Sophic Logo gordian knotLung Cancer Clinical Trials Intelligence

Monthly Update Report for Trials Started in December 2025


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1: Summary data from new trials identified for Lung Cancer.


Overview

Number of Trials: 29

These 29 trials span diverse lung cancer types (NSCLC, SCLC, stage I-IV) and treatment modalities. Most focus on advanced or metastatic disease, testing immunotherapy (PD-1/PD-L1 inhibitors), targeted therapies (EGFR, KRAS, SMARCA inhibitors), chemotherapy combinations, and novel agents (glutamine antagonists, PARP inhibitors, neoantigen vaccines). Several trials explore supportive care (exercise, telerehabilitation, remote monitoring, smoking cessation). Common themes include biomarker-driven selection (EGFR, KRAS, SMARCA4, NFE2L2/KEAP1, SLFN11), combination strategies to overcome resistance, and precision medicine approaches. Trials also address oligoprogression, maintenance therapy, and quality-of-life interventions.

Common Criteria Across Trials

Common Inclusion

  • Age ≥18 years
  • Histologically or cytologically confirmed lung cancer (NSCLC or SCLC)
  • Measurable disease per RECIST 1.1
  • ECOG performance status 0-2
  • Adequate organ function (bone marrow, hepatic, renal)
  • Prior standard therapy (chemotherapy, immunotherapy, or targeted therapy)
  • Ability to provide informed consent
  • Willingness to use contraception (for reproductive-age participants)

Common Exclusion

  • Active brain metastases or leptomeningeal disease (unless treated and stable)
  • Uncontrolled intercurrent illness or active infection
  • Pregnant or breastfeeding
  • Prior or concurrent malignancy interfering with study assessment
  • Active autoimmune disease requiring systemic treatment
  • History of severe hypersensitivity to study drug or similar agents
  • Unresolved toxicity from prior therapy (>Grade 1 or baseline)
  • Use of live vaccines within 30 days
  • Significant cardiac disease or QTc prolongation

Outcomes Summary

Primary Outcomes

Secondary Outcomes


2: Extracted Trials with New Information


Trials with Special Criteria

Genomic / Biomarker Trials

Unique or Unusual Criteria

Trials with Emerging Treatments


3: Individual Trial Overviews


NCT06945484

PILOT for The Precision Exercise Regimen for Cancer Care (PERCC) Study

Organization/Sponsor: University of Utah


Example patient: A 62-year-old English-speaking patient with stage III NSCLC, BMI 28, scheduled for neoadjuvant immunotherapy followed by surgery in four weeks, with no significant mental health concerns.

Phase N/A

Interventions

  • Behavioral: Precision Exercise Regimen for Cancer Care (PERCC)
    Summary: PERCC is a precision exercise intervention targeting improved physical function in stage II-III lung cancer patients undergoing neoadjuvant therapy and surgery, aiming to enhance exercise feasibility and adherence (Web Search).

Key Inclusion

  • Ages 18 and older
  • Stage II and III non-small cell lung cancer
  • Receives neoadjuvant chemotherapy or immunotherapy and surgery
  • Able to complete questionnaires in English or Spanish
  • Agrees to complete PERCC intervention

Key Exclusion

  • Morbidly obese (BMI >40 kg/m2) or anorexic (BMI <17.5 kg/m2)
  • Abnormalities on screening physical exam contraindicting exercise
  • Alcohol or drug abuse
  • Significant mental or emotional problems interfering with compliance
  • Scheduled for single modality cancer treatment
  • Treatment begins within 2 weeks of pre-treatment visit or already started

NCT07224971

Assessing the Impact of Circadian Rhythm on Anti-PD-1/PD-L1 Immunotherapy

Organization/Sponsor: University of Pittsburgh


Example patient: A 62-year-old English-speaking patient with newly diagnosed metastatic NSCLC with high PD-L1 expression, no prior immunotherapy, willing to receive treatment at randomized times of day.

Phase N/A

Interventions

  • Biological: Immunotherapy - PD-1 Blocker
    Summary: PD-1 blocker targets PD-1 on T cells to prevent PD-L1 binding, restoring T cell activity against cancer cells, used in non-small cell lung cancer particularly with high PD-L1 expression (Source: Web Search).

Key Inclusion

  • Advanced/metastatic NSCLC eligible for first-line PD-1/PD-L1 therapy
  • Advanced/metastatic solid tumor eligible for first-line anti-PD-1/PD-L1 therapy
  • Completed up to 4 cycles of induction therapy with stable or responsive disease
  • ICI-naïve or received ICI induction eligible for maintenance
  • Willing to be randomized to assigned time of day for therapy
  • Able to read and write in English

Key Exclusion

  • Unable to receive anti-PD-1/PD-L1 therapy due to prior allergic reactions
  • Allergic to therapy ingredients

NCT07155187

Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan Compared to Standard of Care in Subjects With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer After Progression on a Third-Generation EGFR TKI Genomic-based

Organization/Sponsor: AbbVie


Example patient: A 62-year-old woman with metastatic non-squamous NSCLC harboring EGFR Exon 19 deletion, ECOG status 1, who progressed on osimertinib monotherapy with stable brain metastases after radiation.

Phase 2, Phase 3

Interventions

  • Drug: Telisotuzumab Adizutecan
    Summary: An antibody-drug conjugate targeting c-Met that delivers a topoisomerase inhibitor to tumor cells, inhibiting DNA replication and killing c-Met-expressing cancer cells in NSCLC (NCI Thesaurus).
  • Other: Standard of Care
    Summary: An informed treatment recommendation expected to benefit the greatest number of people within a certain patient group (NCI Thesaurus).

Key Inclusion

  • Locally advanced or metastatic non-squamous NSCLC with EGFR Exon 19 deletion or Exon21 L858R mutation
  • Received one prior third-generation EGFR TKI therapy with documented radiographic progression
  • ECOG Performance Status 0 to 1
  • At least 1 measurable lesion per RECIST v1.1 not previously irradiated
  • CNS metastases must be clinically asymptomatic or stable after treatment
  • Tumor tissue available for analysis

Key Exclusion

  • Adenosquamous, squamous histology, or sarcomatoid features
  • More than 1 line of systemic therapy in locally advanced or metastatic setting
  • Current, historical, or suspected interstitial lung disease or pneumonitis requiring steroids
  • Clinically significant medical conditions interfering with participation

NCT05179408

Telerehabilitation for Veteran Lung Cancer Survivors Following Curative Intent Therapy

Organization/Sponsor: VA Office of Research and Development


Example patient: A 68-year-old Veteran who completed lobectomy for stage II lung cancer three months ago with stable cardiopulmonary function and no cognitive impairment.

Phase N/A

Interventions

  • Behavioral: Waitlist
    Summary: A list of people waiting for inclusion in some activity, vacancy, or service (NCI Thesaurus).
  • Behavioral: Targeted-telerehabilitation
    Summary: Remote exercise and support program aiming to improve physical fitness and psychological health in lung cancer patients, showing similar effectiveness to in-person programs (Summary of Web Search).

Key Inclusion

  • Adult Veterans with stage I-III A/B lung cancer history
  • Completed curative intent therapy within 1-6 months
  • Prior lung cancer resection surgery, definitive radiation, or concurrent chemoradiation

Key Exclusion

  • Orthopedic conditions such as bilateral below-knee amputation
  • Severe cardiopulmonary disease including unstable ventricular tachycardia
  • Heart failure with systolic ejection fraction less than 25%
  • Chronic hypoxemia requiring more than 5 L/min oxygen at rest
  • Inability to follow directions or provide informed consent
  • Moderate to severe dementia
  • Enrolled in hospice
  • Estimated life expectancy less than 6 months

NCT06552000

Phase 0 Trial of Pre-operative Tumor Treating Fields in Patients With Resectable Lung Cancer

Organization/Sponsor: University of Texas Southwestern Medical Center


Example patient: A 58-year-old man with newly diagnosed stage IIA NSCLC, ECOG performance status 1, scheduled for surgical resection without neoadjuvant therapy, with available fresh biopsy tissue.

Phase 0

Interventions

  • Device: NovoTTF-200T System
    Summary: A second generation tumor treatment field (TTField) device that delivers alternating electric fields to disrupt cancer cell division; used pre-operatively in resectable NSCLC (source: NCI Thesaurus).

Key Inclusion

  • Stage I-IIIA NSCLC planned for surgical resection
  • ECOG performance status 0-2
  • Fresh biopsy diagnostic material available (10-15 slides)
  • Age ≥22 years at screening
  • Willingness to undergo correlative imaging studies
  • Adequate contraception required for men and women of child-bearing potential

Key Exclusion

  • Prior therapy for current NSCLC
  • Planned neoadjuvant therapy for current NSCLC
  • History of major allergic reactions to adhesive or TTFields micro-array compounds
  • Uncontrolled infection, symptomatic heart failure, unstable angina, or cardiac arrhythmia
  • Pregnant or nursing patients
  • Use of electronic devices or prosthetics (pacemakers, defibrillators, spinal infusion pumps)

NCT07185997

A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of Osimertinib or Afatinib as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic Non-Small-Cell Lung Cancer With Epidermal Growth Factor Receptor P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations (ALPACCA) Genomic-based

Organization/Sponsor: ArriVent BioPharma, Inc.


Example patient: A 62-year-old treatment-naive patient with metastatic NSCLC harboring an EGFR PACC uncommon mutation detected in tumor tissue, with asymptomatic brain metastases not suitable for curative surgery.

Phase 3

Interventions

  • Drug: Firmonertinib
    Summary: An orally available selective EGFR tyrosine kinase inhibitor targeting the T790M resistance mutation, preventing EGFR-mediated signaling and inducing cell death in T790M-expressing NSCLC tumors (NCI Thesaurus).
  • Drug: EGFR-TKI inhibitor based on investigator's choice
    Summary: EGFR tyrosine kinase inhibitors such as osimertinib or afatinib that block EGFR activity to inhibit cancer cell growth in EGFR-mutated NSCLC (Web Search Summary).

Key Inclusion

  • Histologically or cytologically documented locally advanced or metastatic NSCLC
  • Not amenable to curative surgery or radiotherapy
  • Documented EGFR PACC mutation in tumor tissue or blood
  • No prior systemic anticancer therapy for locally advanced or metastatic NSCLC
  • No prior EGFR-targeting agents including TKIs, monoclonal antibodies, or bispecific antibodies
  • At least 12 months treatment-free interval after neo-adjuvant or adjuvant therapy for non-metastatic disease
  • Asymptomatic CNS metastases are eligible

Key Exclusion

  • Prior systemic therapy for locally advanced or metastatic NSCLC
  • Prior treatment with EGFR-targeting agents
  • Less than 12 months since completion of neo-adjuvant or adjuvant therapy

NCT07285044

Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Pilot, Phase 2 Clinical Trial to Evaluate Administration of Cancer-Directed Therapy in the Patient's Homes Versus in Clinic in the Florida Panhandle and Surrounding Areas

Organization/Sponsor: Mayo Clinic


Example patient: A 62-year-old woman with metastatic lung cancer receiving pembrolizumab infusions, ECOG PS 1, living independently in Pensacola with Wi-Fi access and planning to continue immunotherapy for at least 12 weeks.

Phase 2

Interventions

  • Procedure: Questionnaire Administration
    Summary: Data collection method where participants complete questionnaires to assess outcomes and experiences during at-home cancer therapy administration (NCI Thesaurus).
  • Procedure: Cancer Therapeutic Procedure
    Summary: Standard-of-care cancer interventions including immunotherapies, targeted therapies, and supportive medications administered at home via remote monitoring (NCI Thesaurus).

Key Inclusion

  • Histologically confirmed malignancy receiving eligible treatment regimen
  • Age >= 18 years
  • ECOG performance status 0-3
  • Adequate tolerability of standard-of-care treatment
  • Resides within Florida Panhandle service area
  • Home has Wi-Fi connection or can be provided mobile device
  • Plan to continue eligible treatment >= 12 weeks
  • Social stability appropriate for at-home program

Key Exclusion

  • Co-morbid systemic illnesses making patient inappropriate for study
  • Receiving investigational agent for primary neoplasm
  • Require continuous 24/7 assistance without available caregiver support
  • Current inpatient hospitalization (excluding Advanced Care at Home)

NCT07224464

Open Label Feasibility Dose Escalation Study to Evaluate the Safety of Sarah Nanotechnology System, With Alternating Magnetic Field (AMF) Application in Patients With Advanced Metastatic Solid Tumors.

Organization/Sponsor: New Phase Ltd.


Example patient: A 62-year-old with metastatic pancreatic cancer refractory to chemotherapy, ECOG status 1, no brain metastases, rib circumference 85 cm, and no metallic implants.

Phase N/A

Interventions

  • Device: The Sarah Nanotechnology System
    Summary: A nanotechnology-based system that delivers thermal energy via alternating magnetic field to malignant cells for thermal destruction in advanced metastatic solid tumors. The mechanism induces hyperthermia, raising body temperature to override heat loss and destroy cancer cells (NCI Thesaurus).

Key Inclusion

  • Histologically confirmed advanced metastatic solid tumors between thoracic inlet and pelvic floor
  • Progressed on or after standard therapy, ineligible for surgical resection
  • Measurable disease per RECIST 1.1
  • Exhausted all standard treatment options
  • No prior history of brain metastasis
  • Age ≥18 years
  • Rib cage circumference ≤90 cm
  • ECOG performance status ≤2

Key Exclusion

  • Chemotherapy, radiotherapy, or hormonal therapy within 14 days before screening
  • Immunotherapy or investigational agent within 21 days before screening
  • Residual toxicities >Grade 1 from prior therapy
  • Presence or prior history of brain metastases
  • Uncontrolled intercurrent illness including infection or cardiac conditions
  • Pregnant or breastfeeding
  • Electronic or electronically conductive implants or metals in body
  • Unable to lay down with hands extended over head

NCT06686771

Consolidative Use of Radiotherapy to Block (CURB2) Oligoprogression In Patients With Metastatic Non-Small-Cell Lung Cancer Genomic-based

Organization/Sponsor: Canadian Cancer Trials Group


Example patient: A 62-year-old man with stage IV NSCLC without driver mutations, ECOG 1, who developed three new lung nodules after 6 cycles of pembrolizumab plus chemotherapy, with all lesions amenable to SBRT.

Phase N/A

Interventions

  • Radiation: SBRT
    Summary: Stereotactic body radiation therapy delivers one or several maximum dose radiation treatments targeting body cancers excluding brain or spine, used here to ablate oligoprogressive lesions (NCI Thesaurus).
  • Drug: Second-line standard of care therapy
    Summary: Second preferred systemic therapy used after first-line treatment fails or is not tolerated, applied here as alternative to continued ICI therapy (NCI Thesaurus).

Key Inclusion

  • Metastatic NSCLC stage IV without actionable driver mutation
  • Oligoprogression on first-line ICI +/- chemotherapy after at least 3 cycles
  • All oligoprogressive sites safely treatable with SBRT or ablative radiotherapy
  • ECOG performance status 0, 1, or 2
  • Age ≥18 years
  • Candidate for regulatory approved second-line systemic therapy if randomized to Arm 2
  • Recovered to ≤grade 1 from prior systemic therapy toxicity
  • Stable treated CNS disease without steroids for at least 1 week

Key Exclusion

  • Large-cell neuroendocrine carcinoma, pulmonary carcinoid, or mixed small cell NSCLC
  • Leptomeningeal disease
  • Pregnancy
  • Medical conditions contraindicating radiotherapy (scleroderma, ATM, ILD, Child-Pugh C)
  • Not actively on ICI or ICI + chemotherapy
  • Concurrent treatment with other anti-cancer therapy or investigational agents
  • Live attenuated vaccination within 30 days prior to enrollment
  • Prior or concurrent malignancy interfering with safety or efficacy assessment

NCT06769126

PRISM: PRecIsion in SCLC Via a Multicohort Study: Randomized Phase II Studies Evaluating Maintenance Durvalumab With or Without Biomarker-Directed Therapy for Extensive Stage Small Cell Lung Cancer (ES-SCLC) Genomic-based

Organization/Sponsor: SWOG Cancer Research Network


Example patient: A 62-year-old with extensive stage small cell lung cancer, performance status 1, who completed 4 cycles of carboplatin/etoposide/durvalumab without progression, has adequate tissue for SLFN11 testing, and no symptomatic brain metastases.

Phase II

Interventions

  • Biological: Durvalumab
    Summary: PD-L1 blocking monoclonal antibody that antagonizes programmed death ligand-1, blocking immune checkpoint inhibition and enhancing anti-tumor immune responses in multiple cancer types including small cell lung cancer (NCI Thesaurus, FDA label).
  • Drug: Etoposide
    Summary: Topoisomerase II inhibitor that prevents DNA replication by causing single- or double-strand DNA breaks, used for refractory testicular tumors and small cell lung cancer in combination chemotherapy (NCI Thesaurus, FDA label).
  • Drug: Platinum Compound
    Summary: Chemotherapy compound containing platinum that causes DNA crosslinks and adducts similar to alkylating agents, ultimately inducing apoptosis (NCI Thesaurus).
  • Drug: Ceralasertib
    Summary: Orally available ATR kinase inhibitor that blocks CHK1 phosphorylation, preventing DNA damage checkpoint activation and sensitizing tumor cells to chemo- and radiotherapy (NCI Thesaurus).
  • Biological: Monalizumab
    Summary: Humanized IgG4 monoclonal antibody against NKG2A that blocks HLA-E binding, inducing NK and cytotoxic T-lymphocyte-mediated immune response against cancer cells (NCI Thesaurus).
  • Drug: Saruparib
    Summary: Orally bioavailable PARP inhibitor that prevents DNA repair of single-strand breaks via base-excision repair, enhancing DNA damage accumulation and promoting apoptosis (NCI Thesaurus).
  • Radiation: Thoracic Radiation Therapy
    Summary: Radiation therapy directed at structures in the thoracic cavity for consolidation treatment (NCI Thesaurus).
  • Procedure: Biospecimen Collection
    Summary: Collection of biospecimens for testing, diagnostic, and research purposes including SCLC tissue for SLFN11 biomarker testing and cohort assignment (NCI Thesaurus).
  • Diagnostic: Computed Tomography
    Summary: X-ray imaging method using computer reconstruction to create cross-sectional scans for disease assessment and monitoring (NCI Thesaurus).
  • Diagnostic: Magnetic Resonance Imaging
    Summary: Imaging using radiofrequency waves and magnetic field to provide detailed pictures of internal organs for diagnosis of pathologic conditions including cancer (NCI Thesaurus).
  • Diagnostic: Positron Emission Tomography
    Summary: Imaging technique measuring gamma radiation from positron-electron collisions using metabolically active radionuclides to reveal tissue location of administered substances (NCI Thesaurus).

Key Inclusion

  • Extensive stage small cell lung cancer (ES-SCLC)
  • Treatment naïve or completed 1-3 cycles of platinum plus etoposide with durvalumab
  • Age ≥18 years
  • Zubrod performance status 0-2
  • Adequate tumor tissue available for SLFN11 biomarker testing
  • Completed 4-6 cycles platinum/etoposide and 4 cycles durvalumab induction
  • No disease progression during induction treatment
  • Body weight >30 kg at Step 2

Key Exclusion

  • Prior limited stage small cell lung cancer
  • Received anti-PD-1/PD-L1 other than durvalumab (atezolizumab, pembrolizumab, nivolumab)
  • Grade ≥3 immune-mediated adverse event or unresolved grade 2 irAE during induction
  • Leptomeningeal disease or symptomatic brain metastases
  • Active autoimmune disease requiring systemic treatment in past 2 years
  • History of non-infectious pneumonitis requiring steroids
  • Received prophylactic cranial irradiation
  • Pregnant or nursing

NCT06922539

A Phase 1a/1b Trial in Relapsed/Refractory Small Cell Lung Cancer to Determine the Safety Profile, Pharmacology, and Maximum Tolerated Dose of ST-001, a Fenretinide Phospholipid Suspension (12.5 mg/mL) for Intravenous Infusion

Organization/Sponsor: SciTech Development, Inc.


Example patient: A 62-year-old man with relapsed small cell lung cancer after two prior lines of platinum-based chemotherapy, ECOG performance status 1, normal organ function, and fasting triglycerides of 180mg/dL.

Phase 1

Interventions

  • Drug: Fenretinide
    Summary: A synthetic phenylretinamide analogue of vitamin A that binds and activates retinoic acid receptors inducing cell differentiation and apoptosis, and inhibits tumor growth by modulating angiogenesis-associated factors with retinoid receptor-independent apoptotic properties (NCI Thesaurus).

Key Inclusion

  • Small cell lung cancer (SCLC)
  • At least one measurable disease site using RECIST version 1.1
  • Prior treatment with radiation therapy or platinum-based chemotherapy ± immunotherapy
  • Relapsed/refractory disease of any stage if incurable
  • ECOG performance status 0-1
  • Life expectancy greater than 6 months
  • Normal organ and marrow function
  • Triglyceride blood level (fasting) <300mg/dL

Key Exclusion

  • Mixed SCLC/NSCLC tumors
  • Pregnant or breastfeeding women
  • Receiving other investigational agents
  • History of allergic reactions or sensitivity to retinoids
  • Concurrent treatment with strong CYP3A inducers or moderate to strong CYP3A inhibitors
  • Uncontrolled intercurrent illness including symptomatic CHF, unstable angina, QTc >450ms (men) or >460ms (women)
  • HIV-positive on antiretroviral therapy or active hepatitis infections
  • Presence of nyctalopia, hemeralopia, or other retinal/ophthalmological conditions including glaucoma

NCT07225036

PRIME-LRT: PRomoting IMmunotherapy Efficacy With Low-Dose Liver RT Genomic-based

Organization/Sponsor: University of Cincinnati


Example patient: A 62-year-old man with biopsy-proven metastatic NSCLC without EGFR/ALK mutations, ECOG status 1, with liver metastases on imaging, starting pembrolizumab and planning low-dose liver radiotherapy.

Phase N/A

Interventions

  • Radiation: LD-LRT
    Summary: Low-dose liver radiotherapy (LD-LRT) aims to enhance immunotherapy efficacy by targeting liver metastases with radiation, potentially improving immune response and treatment outcomes in lung cancer and melanoma patients receiving checkpoint inhibitors (source: Web Search).

Key Inclusion

  • Age ≥18 years
  • ECOG performance status ≤2
  • Biopsy proven NSCLC or Melanoma
  • Radiographic evidence of liver metastases
  • Planning active treatment with PD-L1 or PD-1 checkpoint immunotherapy
  • Adequate organ and marrow function for immunotherapy/chemoimmunotherapy
  • Insurance authorization for radiotherapy
  • Adequate contraception for women of child-bearing potential and men

Key Exclusion

  • Adjuvant immunotherapy within 6 months of enrollment
  • NSCLC with EGFR, ALK, ROS1, or RET driver mutations (cohort 1)
  • Uncontrolled intercurrent illness making participation hazardous
  • Prior or concurrent malignancy interfering with safety or efficacy assessment
  • Pregnant women

NCT07220356

C-Raven: Pilot RCT of an Avatar-delivered Computerized Intervention for Tobacco Cessation With Community Health Worker Linkage to Lung Cancer Screening in Baltimore City (FY26)

Organization/Sponsor: Johns Hopkins University


Example patient: A 58-year-old English-speaking current smoker with 40-pack-year history considering quitting, not currently in cessation programs, without cardiovascular contraindications to nicotine replacement, planning to stay in Baltimore for the next year.

Phase N/A

Interventions

  • Procedure: Lung Cancer Screening
    Summary: Screening procedure to detect presence or absence of lung cancer in at-risk individuals (NCI Thesaurus).
  • Other: Community Health Worker
    Summary: Community member providing local health care support tailored to community needs and individual skill set (NCI Thesaurus).
  • Drug: Nicotine Replacement Product
    Summary: Nicotinic cholinergic agonist delivering nicotine systemically to reduce withdrawal symptoms and cravings during smoking cessation; requires monitoring in cardiovascular patients (FDA label, NCI Thesaurus).
  • Behavioral: C-Raven Virtual Tobacco Cessation Counseling
    Summary: Avatar-delivered virtual counseling providing education, recommendations, and interventions to help clients stop tobacco use (NCI Thesaurus).

Key Inclusion

  • Age 50 or older
  • Current tobacco use with >100 cigarettes smoked in lifetime
  • Considering smoking cessation
  • Planning to remain in local area for at least 6 months
  • English speaking

Key Exclusion

  • Contraindication to nicotine replacement therapy
  • Current engagement in formal smoking cessation program
  • Major cognitive or psychiatric impairment
  • Severe hearing impairment

NCT06974370

Avoiding Radiation Therapy Due to Intracranial Response to Chemotherapy, Targeted Therapy and/or Immuno-ONcology Therapy for Brain Metastases: Pilot Pragmatic Trial (ACTION-Brain Metastases: Pilot Pragmatic Trial) Genomic-based

Organization/Sponsor: University of Vermont Medical Center


Example patient: A 62-year-old woman with EGFR-mutant lung adenocarcinoma and two newly diagnosed 2 cm brain metastases, KPS 80, starting osimertinib without prior brain radiation.

Phase N/A

Interventions

  • Procedure: Active Surveillance
    Summary: Closely monitoring patient condition with regular exams and tests without immediate treatment, used to detect early disease progression while avoiding radiation or surgery complications (NCI Thesaurus).

Key Inclusion

  • Pathologically proven solid tumor malignancy within 5 years
  • At least 1 brain metastasis not planned for radiation or surgery
  • Brain metastases ≤3 cm
  • Initiating systemic therapy with brain penetrant targeted therapy, checkpoint inhibitor immunotherapy, HER2 antibody-drug conjugate, or anti-hormone therapy
  • Systemic therapy started or planned within 4 weeks of MRI showing new or progressive disease
  • Age ≥18 years
  • KPS >60
  • Ability to obtain MRI head with contrast, slice thickness ≤1.5 mm

Key Exclusion

  • Use of planned systemic therapy for brain metastases within last 6 months
  • Prior radiotherapy to active brain metastases
  • Pregnant or nursing
  • Known leptomeningeal disease
  • Serious medical comorbidities preventing participation

NCT07249372

A Phase 2 Study of DRP-104, a Glutamine Antagonist, in Patients With NFE2L2/KEAP1-altered Non-Small Cell Lung Cancer Genomic-based

Organization/Sponsor: NYU Langone Health


Example patient: A 62-year-old with ECOG 1, metastatic NSCLC harboring KEAP1 mutation, who progressed after platinum-doublet chemotherapy and pembrolizumab, with stable treated brain metastases and adequate organ function.

Phase 2

Interventions

  • Drug: DRP-104
    Summary: DRP-104 (sirpiglenastat) is a broad-acting glutamine antagonist that converts to DON in tumor cells, irreversibly inhibiting glutamine metabolism enzymes to block tumor cell proliferation and induce death while enhancing T-cell activation in the tumor microenvironment. Source: NCI Thesaurus.

Key Inclusion

  • Advanced or recurrent metastatic or unresectable NSCLC with NFE2L2 or KEAP1 alterations
  • Progression following standard chemotherapy and immune checkpoint inhibitors
  • ECOG Performance Status 0 or 1
  • RECIST measurable lesions
  • Age 18 years or older
  • Adequate organ function including ANC ≥1.5x10^9/L, hemoglobin ≥9 g/dL, platelets >75x10^9/L
  • Creatinine clearance ≥50 ml/min or GFR ≥50 mL/min
  • Corrected QTcF <470 ms

Key Exclusion

  • Progressive or symptomatic brain metastases or leptomeningeal disease
  • Prior glutaminase inhibitor use
  • Unrecovered adverse events from prior therapy (grade >1 except specified exceptions)
  • Prior systemic anticancer treatment within 21 days or 5 half-lives
  • Active Hepatitis B or C, or known HIV
  • Uncontrolled heart disease or baseline QTcF ≥470 ms
  • Potent CYP3A4/5 inducers that cannot be discontinued
  • Other active malignancies except specified exceptions

NCT07284186

A Phase 1, First-in-Human Study of the SMARCA2 Degrader, PLX-61639, in Patients With SMARCA4-Mutated Locally Advanced or Metastatic Solid Tumors Genomic-based

Organization/Sponsor: Plexium, Inc.


Example patient: A 62-year-old with metastatic non-small cell lung cancer harboring somatic SMARCA4 loss-of-function mutation, ECOG PS 1, who progressed on platinum chemotherapy and immunotherapy with no CNS involvement or cardiac disease.

Phase 1

Interventions

  • Drug: PLX-61639
    Summary: PLX-61639 is a SMARCA2 degrader that induces selective degradation to inhibit tumor growth in SMARCA4-mutated solid tumors, currently in Phase 1 trials (Source: Web Search).

Key Inclusion

  • Locally advanced or metastatic solid tumors with SMARCA4 loss-of-function mutation
  • Relapsed/refractory disease progressed on or intolerant to approved therapies
  • Adequate liver, bone marrow, coagulation, renal, and cardiopulmonary function
  • Measurable disease per RECIST 1.1
  • ECOG performance status 0 or 1

Key Exclusion

  • Germline SMARCA4 mutations
  • Known SMARCA2 mutation or loss of expression
  • Symptomatic CNS disease
  • Prior treatment with SMARCA2-directed therapy
  • History of other malignancies
  • Clinically significant heart disease
  • Uncontrolled hypertension
  • Prolongation of QT interval

NCT07227025

A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Olomorasib Combination Therapy in Metastatic Non-small Cell Lung Cancer Genomic-based

Organization/Sponsor: Janssen Research & Development, LLC


Example patient: A 62-year-old with metastatic NSCLC harboring KRAS G12C mutation, ECOG status 1, who progressed after platinum-doublet chemotherapy and pembrolizumab, with no other driver mutations and no prior KRAS inhibitor treatment.

Phase 1, Phase 2

Interventions

  • Drug: Olomorasib
    Summary: Olomorasib is an orally available inhibitor selectively targeting the KRAS G12C mutation, blocking constitutive signaling that drives tumor growth, proliferation, invasion, and metastasis in KRAS G12C mutant cancers (NCI Thesaurus).
  • Biological: Amivantamab
    Summary: Amivantamab is a bispecific antibody targeting EGFR and MET receptors, inhibiting tumor signaling pathways, inducing receptor degradation, and causing ADCC; FDA-approved for NSCLC with specific EGFR mutations (FDA label, NCI Thesaurus).

Key Inclusion

  • Metastatic NSCLC with KRAS G12C mutation
  • Progressed on or after platinum-based chemotherapy and PD-L1 immunotherapy
  • At least 1 measurable lesion per RECIST v1.1 not previously irradiated
  • ECOG performance status 0 or 1
  • Brain metastases allowed if definitively treated and clinically stable for >2 weeks

Key Exclusion

  • History of uncontrolled illness
  • Allergies to amivantamab or olomorasib excipients
  • History or current interstitial lung disease or pneumonitis
  • Presence of other primary driver mutations (EGFR, ALK, MET, HER2, ROS1, NTRK, BRAF, RET, NRAS, non-G12C KRAS)
  • Prior treatment with any KRAS inhibitor

NCT07252739

KEYMAKER-U01 Substudy 01J: A Randomized Phase 2 Umbrella Study With Rolling Arms of Investigational Agents for First-line Treatment of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations Genomic-based

Organization/Sponsor: Merck Sharp & Dohme LLC


Example patient: A 62-year-old with newly diagnosed metastatic nonsquamous NSCLC harboring KRAS G12C mutation detected by ctDNA testing, no prior systemic therapy for advanced disease, and adequate organ function without active autoimmune conditions.

Phase 2

Interventions

  • Drug: Pemetrexed
    Summary: Folate analog metabolic inhibitor that disrupts nucleotide synthesis by inhibiting thymidylate synthase and other enzymes, indicated for non-squamous NSCLC in combination with platinum chemotherapy or pembrolizumab (FDA label, NCI Thesaurus).
  • Drug: Carboplatin
    Summary: Second-generation platinum compound that forms DNA cross-links causing apoptosis, with similar efficacy to cisplatin but improved tolerability, indicated for ovarian and other solid tumors (FDA label, NCI Thesaurus).
  • Biological: Cetuximab
    Summary: Chimeric monoclonal antibody targeting EGFR extracellular domain to inhibit receptor activation and tumor proliferation, indicated for head and neck cancer and K-Ras wild-type colorectal cancer (FDA label, NCI Thesaurus).
  • Biological: Pembrolizumab
    Summary: Humanized anti-PD-1 monoclonal antibody that blocks immune checkpoint signaling to enhance T-cell-mediated tumor destruction, approved for multiple solid tumors including NSCLC, often requiring PD-L1 testing (FDA label, NCI Thesaurus).
  • Drug: MK-1084
    Summary: Orally available selective inhibitor of KRAS G12C mutation that blocks constitutive oncogenic signaling to halt tumor proliferation and metastasis in KRAS G12C-mutant cancers (NCI Thesaurus).

Key Inclusion

  • Histologically or cytologically confirmed advanced or metastatic nonsquamous NSCLC
  • KRAS G12C mutation detected in tumor tissue or circulating tumor DNA
  • Archival or newly obtained tumor biopsy available
  • Recovered to Grade 1 or baseline from prior anticancer therapy adverse events
  • Well-controlled HIV on antiretroviral therapy if HIV-infected
  • Undetectable HBV viral load with at least 4 weeks antiviral therapy if HBsAg positive
  • Undetectable HCV viral load if HCV-infected

Key Exclusion

  • Small cell lung cancer or mixed tumors with small cell elements
  • Prior systemic anticancer therapy for advanced or metastatic NSCLC
  • Previous treatment with KRAS-targeting agent
  • Prior immunotherapy discontinued due to Grade 3+ immune-related adverse event
  • Active CNS metastases or carcinomatous meningitis
  • History of pneumonitis or interstitial lung disease requiring steroids
  • Uncontrolled cardiovascular disease or QTcF >470 ms
  • Active autoimmune disease requiring systemic treatment in past 2 years

NCT07276789

A Phase 2, Open-Label, Multicenter Study to Investigate the Efficacy and Safety of a Single Dose of LS301-IT for Fluorescence Intraoperative Molecular Imaging (IMI) for Lung Cancer Resection

Organization/Sponsor: Integro Theranostics


Example patient: A 62-year-old male with CT-confirmed lung mass suspicious for cancer, scheduled for thoracoscopic resection, with normal liver and renal function and no prior chest radiation.

Phase 2

Interventions

  • Drug: LS301-IT 0.1 mg/kg
    Summary: Cronexitide lanocianine is a near-infrared fluorescent probe combining cypate dye with a cyclic octapeptide that targets integrin receptors on tumor cells for intraoperative imaging. It enables surgeons to visualize and remove cancer cells during resection using Cancer Vision Goggles. Source: NCI Thesaurus.

Key Inclusion

  • Primary diagnosis or high clinical suspicion for lung cancer based on CT, biopsy, or imaging
  • Scheduled to undergo surgical thoracoscopy and lung resection
  • Negative serum pregnancy test at screening and Day 1 if of childbearing potential
  • Using medically acceptable contraception or abstinence if of childbearing potential
  • Ability to understand study requirements

Key Exclusion

  • Contraindications for surgery or medical conditions jeopardizing safety
  • History of drug-related hypersensitivity, anaphylactic reactions, or ICG/contrast agent allergies
  • Impaired renal function
  • Clinically significant ECG abnormalities or cardiac conduction abnormalities
  • History of chest radiation therapy
  • Total bilirubin >1.5 times upper limit
  • AST/SGOT and ALT/SGPT >2.5 times upper limit of normal
  • Pregnant or breastfeeding

NCT05467748

Phase Ib/II Study of Safety and Efficacy of EZH2 Inhibitor, Tulmimetostat, and PD-1 Blockade for Treatment of Advanced Non-small Cell Lung Cancer Genomic-based

Organization/Sponsor: VA Office of Research and Development


Example patient: A 62-year-old male veteran with metastatic NSCLC (EGFR/ALK negative) and ECOG 1, who progressed 8 weeks after completing 6 cycles of pembrolizumab plus platinum-based chemotherapy, with adequate organ function and no active autoimmune disease.

Phase 1, Phase 2

Interventions

  • Biological: Pembrolizumab
    Summary: Humanized monoclonal IgG4 antibody blocking PD-1 receptor, enhancing T-cell-mediated immune responses against tumors. FDA-approved for multiple cancers including NSCLC, often combined with chemotherapy. Source: FDA label, NCI Thesaurus.
  • Drug: Tulmimetostat
    Summary: EZH2 inhibitor being investigated in combination with PD-1 blockade for advanced NSCLC treatment. Mechanism targets epigenetic regulation to potentially enhance immunotherapy response.

Key Inclusion

  • Histologically confirmed advanced non-small cell lung cancer
  • Progressed on anti-PD-1/L1 therapy (at least 2 doses) as monotherapy or combination
  • Disease progression within 12 weeks from last anti-PD-1/L1 dose
  • Measurable disease per RECIST v1.1
  • ECOG performance status 0-1
  • Life expectancy of at least 12 weeks
  • Adequate organ function including ANC ≥1500/mm3, platelets ≥100,000/mm3
  • Archival or newly obtained tumor tissue sample available

Key Exclusion

  • EGFR or ALK altered patients
  • Immunotherapy naïve patients
  • Prior exposure to tulmimetostat or other EZH2 inhibitors
  • Clinically active cerebral metastases requiring steroids within one month
  • Active autoimmune disease requiring systemic treatment within past 2 years
  • HIV positive, active Hepatitis B or C
  • Taking strong CYP3A4 inducers or inhibitors
  • History of non-infectious pneumonitis requiring steroids or current pneumonitis

NCT07315113

A Phase 1b Clinical Study of NXP900 in Combination With Osimertinib in Subjects With Advanced, EGFRMut+ Non-Small Cell Lung Cancer Genomic-based

Organization/Sponsor: Nuvectis Pharma, Inc.


Example patient: A 62-year-old with ECOG 1, metastatic EGFR-mutated NSCLC previously treated with first-line osimertinib plus chemotherapy, without HER2 overexpression or other oncogenic drivers.

Phase 1b

Interventions

  • Drug: Osimertinib
    Summary: A third-generation oral irreversible EGFR tyrosine kinase inhibitor targeting mutant EGFR including T790M, L858R, and exon 19 deletions, used for NSCLC treatment while sparing wild-type EGFR. Source: FDA label, NCI Thesaurus.
  • Drug: NXP900
    Summary: An oral SRC/YES1 kinase inhibitor that locks these kinases in closed conformation, blocking oncogenic signaling pathways in tumors overexpressing SRC family kinases. Source: NCI Thesaurus.

Key Inclusion

  • 18 years old or older
  • ECOG performance status of 0-1
  • Unresectable, metastatic or locally advanced EGFR-mutated NSCLC
  • Prior treatment with osimertinib as first or second line
  • Osimertinib as single agent or in combination with chemotherapy

Key Exclusion

  • Known oncogenic driver alteration other than EGFR
  • Known EGFR mutations that cause resistance to osimertinib
  • Known HER2 overexpression
  • Contraindications to treatment with osimertinib

NCT06861088

A Randomized, Placebo-Controlled, Double-Blind Phase 3 Trial Comparing, Relative to Placebo, the Effect of Kinisoquin on Thromboembolic Events in Patients With Metastatic Pancreatic Cancer (CATIQ P3)

Organization/Sponsor: Quercis Pharma AG


Example patient: A 62-year-old with newly diagnosed metastatic pancreatic adenocarcinoma, ECOG status 1, starting FOLFIRINOX chemotherapy with no history of bleeding disorders or recent thromboembolic events.

Phase 3

Interventions

  • Drug: Kinisoquin
    Summary: Kinisoquin (Isoquercetin) is an antioxidant and anti-inflammatory compound being studied for prevention of thromboembolic events in metastatic pancreatic cancer patients (source: Web Search).
  • Other: Placebo
    Summary: Inactive compound identical in appearance to Kinisoquin used as control to distinguish drug action from placebo effect (source: NCI Thesaurus).

Key Inclusion

  • Histologically or cytologically confirmed advanced metastatic pancreatic adenocarcinoma
  • Receiving first line chemotherapy within 30 days of first study drug dose
  • Age 18 years or older
  • Life expectancy greater than 6 months
  • ECOG performance status ≤2
  • Adequate organ and marrow function
  • Willingness to use contraception during study participation

Key Exclusion

  • Known brain metastases
  • Thromboembolic event within last 2 years
  • Active bleeding or high bleeding risk
  • Currently receiving anticoagulant therapy
  • Daily aspirin >81mg or antiplatelet agents
  • Known intolerance of quercetin, niacin, or ascorbic acid
  • Pregnant or lactating females
  • Participation in other clinical trials

NCT07226999

A GLOBAL PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER

Organization/Sponsor: Pfizer


Example patient: A 62-year-old male with newly diagnosed extensive-stage small cell lung cancer, ECOG performance status 1, no prior systemic therapy, adequate organ function, and no active CNS metastases or autoimmune disease.

Phase 2, Phase 3

Interventions

  • Drug: Chemotherapy
    Summary: Synthetic or naturally-occurring chemicals used for disease treatment (NCI Thesaurus).
  • Biological: Atezolizumab
    Summary: Humanized monoclonal antibody blocking PD-L1, enhancing T-cell immune response against tumors; indicated for small cell lung cancer and other cancers (FDA label, NCI Thesaurus).
  • Drug: PF-08634404
    Summary: Investigational agent studied in combination with chemotherapy for non-small cell and small cell lung cancer; mechanism not publicly disclosed (Web Search).

Key Inclusion

  • Histologically or cytologically confirmed extensive-stage small cell lung cancer
  • No prior systemic therapy for ES-SCLC
  • Treatment-free for at least 6 months if prior limited-stage SCLC therapy
  • At least one measurable lesion per RECIST V1.1
  • ECOG performance status 0 or 1
  • Adequate organ function

Key Exclusion

  • Known active CNS lesions including brainstem, meningeal, or spinal cord metastases
  • Leptomeningeal disease
  • Clinically significant risk of hemorrhage or fistula
  • History of another malignancy within 3 years
  • Active autoimmune diseases requiring systemic treatment within past 2 years

NCT04266730

Phase I Trial of a Personalized and Adaptive Neoantigen Dose-Adjusted Vaccine Administered Concurrently With Pembrolizumab Genomic-based

Organization/Sponsor: UNC Lineberger Comprehensive Cancer Center


Example patient: A 62-year-old man with metastatic squamous NSCLC (PD-L1 TPS 40%, EGFR/ALK negative) showing stable disease after 4 cycles of pembrolizumab, ECOG 1, with adequate organ function and available archival tumor tissue for neoantigen sequencing.

Phase 1

Interventions

  • Biological: Pembrolizumab
    Summary: Humanized monoclonal IgG4 antibody blocking PD-1 receptor on T cells, preventing ligand binding and enhancing T-cell-mediated immune responses against tumors; FDA-approved for multiple solid and hematologic malignancies including NSCLC and head/neck cancers (FDA label, NCI Thesaurus).
  • Biological: PANDA-VAC
    Summary: Personalized peptide vaccine containing up to 8 patient-specific tumor neoantigens identified via tumor sequencing, combined with poly-ICLC adjuvant (TLR3 agonist) to stimulate cytotoxic T-lymphocyte responses against tumor cells expressing those neoantigens (NCI Thesaurus).

Key Inclusion

  • Histologically confirmed squamous NSCLC or head and neck squamous cell carcinoma
  • PD-L1 positive (TPS ≥1% for NSCLC, CPS ≥1 for SCCHN)
  • Stable disease, mixed response, oligoprogressive or non-threatening progression on PD-1/PD-L1 therapy
  • ECOG performance status ≤1 for vaccine generation, ≤2 for vaccination
  • Adequate archival tumor tissue for sequencing
  • Radiographically measurable disease per RECIST 1.1
  • Age ≥18 years
  • Adequate bone marrow, hepatic, and renal function

Key Exclusion

  • Active CNS metastases or leptomeningeal disease
  • Systemic corticosteroids ≥10mg prednisone daily or immunosuppressive medications
  • Active autoimmune disease requiring systemic treatment in past 2 years
  • Known HIV, active HCV, or active HBV
  • History of organ or stem cell transplant
  • Active infection requiring systemic therapy
  • Pregnant or breastfeeding
  • Additional active malignancy requiring treatment

NCT07104630

Pulmonary Rehabilitation in Advanced Lung Cancer Survivors

Organization/Sponsor: Case Comprehensive Cancer Center


Example patient: A 62-year-old English-speaking adult with Stage IV NSCLC on palliative therapy, ECOG status 2, experiencing moderate dyspnea but clinically stable without recent progression or cardiac complications.

Phase N/A

Interventions

  • Behavioral: No intervention: Usual care
    Summary: A study arm without an intervention or treatment, serving as control (NCI Thesaurus).
  • Behavioral: Pulmonary Rehabilitation (PR)
    Summary: Treatment programs using strategies to maintain function, participation and quality of life for individuals with pulmonary disorders (NCI Thesaurus).

Key Inclusion

  • Histologically confirmed NSCLC, Stages III or IV treated with palliative intent
  • Adults ≥18 years of age
  • ECOG performance status ≤3
  • Clinical stability with no progression within last three months
  • Self-reported dyspnea score ≥2 on modified Medical Research Council Dyspnea Scale
  • Fluent in written and spoken English

Key Exclusion

  • Treated with curative intent for locally advanced or oligometastatic NSCLC with concurrent chemoradiation
  • Evidence of clinical and/or radiographic progression
  • Mental impairment preventing study completion
  • High risk of fracture or spine instability (Mirels score ≥7 or SINS ≥7)
  • NYHA Class II-IV heart failure
  • Acute coronary syndromes, angioplasty or stenting within past 6 months
  • Acute pulmonary embolus or infarction within last 3 months
  • Respiratory failure or pulmonary edema

NCT07235280

An Open-Label Safety and Tolerability Pilot Study of Dapagliflozin in Stage IA Lung Adenocarcinoma

Organization/Sponsor: Jonsson Comprehensive Cancer Center


Example patient: A 58-year-old non-diabetic woman with newly diagnosed stage Ia lung adenocarcinoma, ECOG 0, normal organ function, scheduled for surgical resection, willing to undergo research biopsy for Ki-67 analysis.

Phase N/A

Interventions

  • Drug: Dapagliflozin Propanediol
    Summary: SGLT2 inhibitor that blocks renal glucose reabsorption, FDA-approved for diabetes, heart failure, and chronic kidney disease; being studied for safety in stage IA lung adenocarcinoma (FDA label, NCI Thesaurus).
  • Procedure: Computed Tomography Assisted Biopsy
    Summary: CT-guided needle biopsy procedure to obtain lung tissue for Ki-67 determination (NCI Thesaurus).
  • Procedure: Biospecimen Collection
    Summary: Collection of biological samples for testing, diagnostic, or research purposes (NCI Thesaurus).
  • Other: Questionnaire Administration
    Summary: Administration of questionnaires to participants for data collection (NCI Thesaurus).

Key Inclusion

  • Histologically confirmed stage Ia lung adenocarcinoma
  • Planning to undergo surgery for lung adenocarcinoma
  • Age ≥22 years
  • ECOG performance status ≤1
  • Availability of biopsy tissue for Ki-67 determination
  • Willing to receive CT-guided lung biopsy
  • Adequate hematologic function (leukocytes ≥3.0 K/mm³, ANC ≥1.5 K/mm³, platelets ≥100 K/mm³)
  • eGFR ≥30 mL/min/1.73m²

Key Exclusion

  • Current or previous treatment with SGLT2 inhibitors
  • Pregnant or breastfeeding
  • History of other malignancies within 2 years
  • Currently receiving other investigational agents
  • Regular systemic steroids >10 mg prednisone daily equivalent
  • Allergic reactions to dapagliflozin or similar compounds
  • Severe kidney disease (eGFR <30 mL/min/1.73m²)
  • HIV with CD4+ <350 cells/µL or AIDS-defining infection within 12 months

NCT06869447

Lung Cancer Better Breathing Study

Organization/Sponsor: Roswell Park Cancer Institute


Example patient: A 62-year-old non-Hispanic White male, 10 months post-surgery for stage II lung cancer, completed chemotherapy and radiation, sedentary lifestyle, English-speaking, willing to provide blood samples.

Phase N/A

Interventions

  • Procedure: Sham Intervention
    Summary: A control procedure mimicking the intervention under investigation in all aspects without actually performing the studied procedure (NCI Thesaurus).
  • Procedure: Respiratory Muscle Training
    Summary: Breathing and exercises designed to improve respiratory muscle function through resistance and endurance training (NCI Thesaurus).
  • Other: Questionnaire Administration
    Summary: The act of having an individual fill out a questionnaire for data collection (NCI Thesaurus).
  • Device: Medical Device Usage and Evaluation
    Summary: Classification term for medical device usage and performance evaluation (NCI Thesaurus).
  • Other: Electronic Health Record Review
    Summary: Checking and assessing data present in an electronic health record (NCI Thesaurus).
  • Procedure: Biospecimen Collection
    Summary: Gathering biospecimens such as blood for testing, diagnostic, or research purposes (NCI Thesaurus).

Key Inclusion

  • Age ≥ 18 years
  • Self-identify as non-Hispanic Black or White
  • < 15 months of histologically confirmed invasive, non-metastatic lung cancer diagnosis
  • Received surgical treatment (primarily stage I, II, III)
  • Completed all cancer treatments (surgery, chemotherapy, radiation)
  • Willing to provide blood biospecimen samples
  • Able to speak, read and comprehend English

Key Exclusion

  • Metastatic (stage IV) at study entry
  • Contraindications for respiratory muscle training (pulmonary embolism, aortic aneurysm, pneumothorax)
  • Actively engaging in structured exercise program or meeting exercise guidelines
  • Unwilling or unable to follow protocol requirements

NCT07155200

Small Cell Lung Cancer Irinotecan and CDC2-like Kinase Inhibition Trial (SLICK Trial)

Organization/Sponsor: Washington University School of Medicine


Example patient: A 62-year-old patient with ECOG performance status 1 and relapsed small cell lung cancer after first-line platinum-doublet chemotherapy, with measurable lung lesions and adequate organ function.

Phase N/A

Interventions

  • Drug: Irinotecan
    Summary: A topoisomerase I inhibitor that is converted to active metabolite SN-38, which stabilizes the DNA-topoisomerase I complex causing DNA breaks and apoptosis in S-phase cancer cells; FDA-approved for metastatic colorectal cancer (FDA label, NCI Thesaurus).
  • Drug: Cirtuvivint
    Summary: An investigational agent that modulates alternative pre-mRNA splicing to reduce expression of genes promoting tumor growth, particularly in small cell lung cancer (Web Search Summary).

Key Inclusion

  • Histologically or cytologically confirmed small cell lung cancer
  • Progressed on at least one line of prior platinum-based chemotherapy
  • Measurable disease per RECIST 1.1 criteria
  • At least 18 years of age
  • ECOG performance status ≤ 2
  • Adequate bone marrow function (ANC ≥ 1.0 K/cumm, platelets ≥ 100 K/cumm)
  • Adequate organ function (bilirubin ≤ 1.5x ULN, AST/ALT ≤ 2.5x ULN)
  • Creatinine clearance > 35 mL/min by Cockcroft-Gault

Key Exclusion

  • Previous intolerance to irinotecan
  • Untreated symptomatic brain metastases or clinically evident CNS hemorrhage
  • Concurrent diarrheal illness requiring medical therapy
  • Major surgery within 28 days prior to treatment
  • Clinically significant liver disease or cirrhosis Child-Pugh B or worse
  • Unresolved grade 2 or higher toxicities from previous treatment
  • Pregnant or breastfeeding
  • Known retinal abnormalities including diabetic retinopathy or macular degeneration

NCT06682013

A Randomized Pilot Study Comparing the Feasibility of Using a Virtual Agent vs. an Off-site Human Agent to Onboard Oncology Patients to a Remote Monitoring Device

Organization/Sponsor: Duke University


Example patient: A 52-year-old English-speaking woman with metastatic breast cancer, ECOG status 1, weighing 75 kg with normal vital signs, scheduled for three consecutive chemotherapy infusion visits at Duke Cancer Center.

Phase N/A

Interventions

  • Behavioral: Human agent
    Summary: Off-site human personnel assist oncology patients with onboarding to remote patient monitoring devices over three consecutive clinic days (source: Summary of Web Search).
  • Behavioral: Virtual agent
    Summary: Digital virtual agent provides automated assistance to oncology patients for remote monitoring device onboarding and adherence support (source: Summary of Web Search).

Key Inclusion

  • Age ≥18 years
  • Solid tumor cancer diagnosis
  • Planning to return to Duke Cancer Center clinic for three consecutive days
  • ECOG performance status 0-2
  • Native fluency in spoken English
  • Weight ≤180 kg
  • Arm circumference 22-42 cm
  • Vital signs within device-specified ranges

Key Exclusion

  • Vision, speech, auditory, physical, or cognitive impairment interfering with device use
  • Implanted pacemaker
  • History of mastectomy or lymph node clearance
  • Arterio-venous shunt
  • Severe blood flow problems or blood disorders
  • Severe circulatory deficit in arm
  • Pregnancy