Sophic Logo gordian knotLung Cancer Clinical Trials Intelligence

Monthly Update Report for Trials Started in February 2026


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


Overview

Number of Trials: 24

These 24 trials span diverse cancer types including lung (NSCLC, SCLC), breast, head and neck, urothelial, prostate, and others. Most focus on advanced or metastatic disease. Interventions include novel immunotherapies (checkpoint inhibitors, bispecific antibodies), antibody-drug conjugates (ADCs), targeted therapies (EGFR, MET, MAT2A inhibitors), personalized vaccines, and digital health/behavioral interventions. Many trials combine experimental agents with standard chemotherapy or immunotherapy. Several trials emphasize biomarker-driven enrollment (PD-L1, HER2, MTAP deletion, c-MET overexpression). Screening and early detection studies also feature prominently, including AI-guided risk stratification and educational campaigns.

Common Criteria Across Trials

Common Inclusion

  • Age ≥18 years
  • Histologically or cytologically confirmed cancer diagnosis
  • Measurable disease per RECIST v1.1
  • ECOG performance status 0-2
  • Adequate organ function (bone marrow, liver, kidney)
  • Life expectancy ≥3-12 weeks
  • Prior standard therapy or progression on prior lines
  • Willingness to provide informed consent and comply with study procedures
  • Effective contraception for participants of childbearing potential

Common Exclusion

  • Active or untreated brain metastases or leptomeningeal disease
  • Active autoimmune disease requiring systemic immunosuppression
  • Uncontrolled infection requiring IV antibiotics
  • History of interstitial lung disease or pneumonitis
  • Significant cardiovascular disease (recent MI, unstable angina, heart failure)
  • Pregnant or breastfeeding
  • Prior organ or stem cell transplant
  • Known HIV, hepatitis B or C with active infection
  • Concurrent malignancy requiring active treatment
  • Use of systemic corticosteroids >10 mg prednisone equivalent
  • Recent major surgery or radiation therapy
  • Hypersensitivity to study drugs or excipients

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


NCT07227077

An Adaptive Design for Dosing Physical Activity Among Older Cancer Survivors Who Experience Chronic Pain: a Micro-randomized Trial

Organization/Sponsor: Medical College of Wisconsin


Example patient: A 68-year-old English-speaking woman with treated early-stage breast cancer without recurrence or metastases, who owns a smartphone and experiences chronic pain.

Phase N/A

Interventions

  • Behavioral: Physical Activity Promotion Intervention
    Summary: Uses pedometers and tracking to increase exercise and reduce sedentary behavior, targeting improved fatigue, functional ability, muscle strength, and quality of life in cancer survivors (NCI Thesaurus, Web Search).

Key Inclusion

  • Age greater than or equal to 65 years
  • History of bladder, breast, cervical, colorectal, endometrial, lung, or prostate cancer
  • Completed cancer treatment
  • Fluent in spoken and written English
  • Access to smartphone

Key Exclusion

  • Metastatic disease
  • Cancer recurrence

NCT07219251

Engagement of Veterans With Lung Cancer (EVLC)

Organization/Sponsor: Palo Alto Veterans Institute for Research


Example patient: A 62-year-old Spanish-speaking veteran with newly diagnosed stage III lung cancer starting chemotherapy at a VA oncology clinic with capacity to consent and not in hospice.

Phase N/A

Interventions

  • Behavioral: Usual Care Group
    Summary: Standard treatment protocols for lung cancer, often including chemotherapy or other standard therapies without additional interventions (Web Search).
  • Behavioral: Lay Health Worker (LHW) Planning
    Summary: Community member providing support to local health care system based on community needs and individual skill set (NCI Thesaurus).

Key Inclusion

  • Veteran patients with any stage lung cancer
  • 18 years of age or older
  • English- or Spanish-speaking
  • Can self-administer questionnaires
  • Valid telephone number
  • Receiving oncology care at participating sites
  • Newly diagnosed or receiving/completed systemic anti-cancer therapy or radiation within 12 months

Key Exclusion

  • No capacity to consent
  • Actively receiving hospice care

NCT07149363

Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer

Organization/Sponsor: Alliance Foundation Trials, LLC.


Example patient: A 62-year-old with ECOG status 0 who underwent lobectomy with mediastinal lymph node dissection 6 weeks ago for pathologic T1N1M0 small-cell lung cancer, with no prior systemic therapy or recent thromboembolic events.

Phase N/A

Interventions

  • Biological: Durvalumab 50 MG/ML
    Summary: Durvalumab is a PD-L1 blocking monoclonal antibody that antagonizes programmed death ligand-1, enhancing anti-tumor immune responses. It is FDA-approved for multiple cancers including small cell lung cancer, used as monotherapy or with chemotherapy. Sources: FDA label, NCI Thesaurus.

Key Inclusion

  • Age ≥18 years
  • Pathologic T1-T2 N0-1 M0 small-cell lung cancer
  • Completely resected SCLC within 78 days of enrollment
  • Complete mediastinal lymph node dissection or systematic sampling required
  • No prior systemic therapies for small cell lung cancer
  • ECOG performance status 0-1
  • Life expectancy at least 12 weeks
  • Body weight >30 kg

Key Exclusion

  • Receiving other investigational agents
  • Prior treatment with durvalumab
  • Active malignancy within 2 years except low-risk cancers
  • Cerebrovascular accident, TIA, pulmonary embolism, or DVT within 3 months
  • Hemoptysis exceeding 2.5 mL within 2 weeks
  • Concomitant phenytoin, phenobarbital, or carbamazepine therapy

NCT07057791

Phase II Dose Optimization Study of Platinum/Etoposide Plus Ivonescimab (CEI) as First-Line Treatment of Extensive-Stage Small Cell Lung Cancer

Organization/Sponsor: PrECOG, LLC.


Example patient: A 62-year-old treatment-naive patient with extensive-stage small cell lung cancer, ECOG performance status 1, adequate organ function, no CNS metastases, and controlled blood pressure on antihypertensive therapy.

Phase II

Interventions

  • Bispecific Antibody: Ivonescimab 20 mg/kg
    Summary: Bispecific antibody targeting PD-1 and VEGF that blocks immune checkpoint inhibition and angiogenesis, enhancing T-cell-mediated tumor lysis and inhibiting vascular proliferation in cancer treatment (NCI Thesaurus).
  • Bispecific Antibody: Ivonescimab 10 mg/kg
    Summary: Bispecific antibody targeting PD-1 and VEGF that blocks immune checkpoint inhibition and angiogenesis, enhancing T-cell-mediated tumor lysis and inhibiting vascular proliferation in cancer treatment (NCI Thesaurus).

Key Inclusion

  • Pathologically confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC)
  • No prior systemic therapy for ES-SCLC
  • Measurable disease per RECIST v1.1
  • Age ≥18 years
  • ECOG performance status 0-1
  • Adequate organ and marrow function
  • Willing to provide archived tumor tissue and blood samples
  • Effective contraception during study and 120 days after last dose

Key Exclusion

  • Symptomatic CNS metastases, CNS metastasis ≥1.5 cm, or leptomeningeal disease
  • Major blood vessel invasion or tumor invading organs on imaging
  • History of bleeding tendencies, hemoptysis ≥0.5 teaspoon, or coagulopathy within 4 weeks
  • Major cardiovascular events or arterial thromboembolic events within 12 months
  • Active autoimmune or lung disease requiring systemic therapy within 2 years
  • Poorly controlled hypertension (systolic ≥150 or diastolic ≥100 mmHg)
  • Pre-existing peripheral neuropathy ≥Grade 2
  • Active infection requiring systemic therapy within 2 weeks

NCT07189871

A Phase 1/2a Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors

Organization/Sponsor: Radiopharm Theranostics, Ltd


Example patient: A 62-year-old man with metastatic castration-resistant prostate cancer progressing after enzalutamide and abiraterone, ECOG 1, with adequate organ function and life expectancy of 6 months.

Phase 1, Phase 2

Interventions

  • Radiopharmaceutical: 177Lu-BetaBart
    Summary: 177Lu-BetaBart is a radiolabeled monoclonal antibody that targets B7-H3 protein on cancer cells, delivering lutetium-177 radiation directly to tumors for targeted radiotherapy. It is being studied for treatment of various solid tumors including breast, lung, and prostate cancers. Source: Web Search.

Key Inclusion

  • Age ≥18 years
  • Histopathologically confirmed CRPC, CRC, NSCLC, SCLC, HNSCC, ovarian, cervical, endometrial, TNBC, or ESCC
  • Documented disease progression during or after most recent anticancer therapy
  • Refractory to or intolerant of standard of care therapy or no standard therapy available
  • At least 1 measurable target lesion per RECIST v1.1 (except CRPC)
  • ECOG performance status ≤2
  • Life expectancy ≥4 months
  • Adequate organ function: eGFR ≥50 mL/min, platelets ≥100×10⁹/L, ANC ≥1.5×10⁹/L, hemoglobin ≥9 g/dL

Key Exclusion

  • Prior organ transplant
  • Active malignancy except treated cervical intraepithelial neoplasia or non-melanoma skin cancer
  • Residual toxicity ≥Grade 2 from prior anticancer therapy (except alopecia and peripheral neuropathy)
  • eGFR <50 mL/min, platelets <100×10⁹/L, ANC <1.5×10⁹/L, hemoglobin <9 g/dL
  • ALT or AST >3×ULN (>5×ULN with liver metastases)
  • Prior Lu-177-PSMA radioligand therapy for CRPC patients
  • Clinically significant cardiovascular disease including NYHA Class II or greater heart failure, QTcF >480 msec
  • Active hepatitis B or C infection

NCT07277413

A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE892 as Monotherapy and Combination Therapy in Participants With MTAP-Deleted Advanced Solid Tumors Genomic-based

Organization/Sponsor: IDEAYA Biosciences


Example patient: A 62-year-old with metastatic MTAP-deleted NSCLC adenocarcinoma, ECOG PS 1, who progressed after platinum-based chemotherapy and pembrolizumab, with adequate organ function and no brain metastases.

Phase 1

Interventions

  • Drug: IDE397
    Summary: An orally bioavailable MAT2A inhibitor that blocks S-adenosyl-L-methionine synthesis, exploiting synthetic lethality in MTAP-deleted cancers by disrupting methylation pathways essential for tumor cell proliferation. Source: NCI Thesaurus.
  • Drug: IDE892
    Summary: A PRMT5 inhibitor designed to target MTAP-deleted tumors through synthetic lethality, disrupting protein arginine methylation critical for cancer cell survival. Source: Summary of Web Search.

Key Inclusion

  • Age ≥18 years
  • Histologically confirmed locally advanced recurrent or metastatic solid tumor with MTAP deletion
  • Homozygous loss of MTAP or MTAP deletion confirmed
  • At least 1 measurable lesion per RECIST v1.1
  • ECOG Performance Status 0 or 1
  • Life expectancy >3 months
  • Adequate bone marrow and organ function
  • NSCLC progressed after platinum chemotherapy and PD-1/PD-L1 inhibitor

Key Exclusion

  • Symptomatic brain metastases requiring supraphysiologic corticosteroids
  • Known primary CNS malignancy
  • Other malignancies within 2 years
  • Impaired cardiac function or clinically significant cardiac disease
  • Uncontrolled effusions requiring recurrent drainage within 2 weeks
  • Severe infections within 4 weeks prior to treatment
  • Prior treatment with MAT2A or PRMT inhibitor
  • Use of proton pump inhibitors within 7 days

NCT07227480

Advancing Lung Cancer Screening One Text at a Time

Organization/Sponsor: University of Rochester


Example patient: A 62-year-old current smoker with a 30 pack-year history who speaks English, has not had lung cancer screening this year, and owns a cellphone with unlimited texting.

Phase N/A

Interventions

  • Behavioral: Educational material
    Summary: Educational materials inform patients about lung cancer screening, targeting knowledge gaps to improve adherence and decision-making (NCI Thesaurus, Web Search Summary).
  • Behavioral: Text messaging program
    Summary: Automated text messages provide reminders and information to encourage lung cancer screening participation and improve adherence (NCI Thesaurus, Web Search Summary).

Key Inclusion

  • 50 to 80 years old
  • have not completed annual screening for lung cancer
  • 20 pack-year smoking history
  • currently smoke or quit within past 15 years
  • speak English and/or Spanish
  • functioning cellphone with unlimited text messaging
  • willing to complete baseline and Month 3 follow-up survey

Key Exclusion

  • up-to-date on annual lung cancer screening

NCT07405086

Knight Cancer Institute Study of Histology-Agnostic Immunotherapy With Focus on Timing: - Knight SHIFT - A Prospective, Multi-Histology Pragmatic Study Genomic-based

Organization/Sponsor: OHSU Knight Cancer Institute


Example patient: A 62-year-old patient with metastatic driver-negative non-small cell lung cancer and measurable disease, no prior immunotherapy, and no active CNS metastases, planned for pembrolizumab treatment.

Phase N/A

Interventions

  • Drug: Immune Checkpoint Inhibitor
    Summary: Targets proteins like PD-1, PD-L1, and CTLA-4 to enhance immune response against cancer cells by blocking inhibitory checkpoint pathways. Used across multiple cancer types to improve treatment outcomes. Source: NCI Thesaurus and Web Search.
  • Procedure: Biospecimen Collection
    Summary: Gathering of tissue and fluid samples for research to analyze genetic and molecular features of cancer. Supports understanding of cancer mechanisms and development of targeted therapies. Source: NCI Thesaurus and Web Search.

Key Inclusion

  • Aged ≥ 18 years
  • Histologically confirmed advanced/metastatic solid tumor (NSCLC driver-negative ICI-eligible, HNSCC platinum-eligible, RCC, BTC, HCC, melanoma)
  • Planned to receive FDA-approved immune checkpoint inhibitor regimen
  • Measurable disease per RECIST 1.1

Key Exclusion

  • Prior ICI-based regimen for treatment of cancer
  • Immunosuppressive medication within 28 days before immunotherapy (except intranasal/inhaled corticosteroids or ≤10 mg/day prednisone equivalent)
  • Uncontrolled autoimmune disease requiring immunosuppression
  • Active, uncontrolled CNS metastases

NCT07133425

A Phase 2 Platform Study of Immunomodulatory Compounds in ICI-refractory Non-small Cell Lung Cancer

Organization/Sponsor: M.D. Anderson Cancer Center


Example patient: A 62-year-old with metastatic NSCLC and ECOG status 1 who progressed after 8 weeks of pembrolizumab and platinum-doublet chemotherapy, with stable treated brain metastases and adequate organ function.

Phase 2

Interventions

  • Biological: SAR445877
    Summary: A fusion protein combining an anti-PD-1 antibody with an IL-15 mutein that inhibits PD-1 checkpoint signaling while stimulating NK cells and cytotoxic T-cells in the tumor microenvironment. Designed to restore immune function and induce anti-tumor responses in checkpoint inhibitor-refractory cancers. Source: NCI Thesaurus.

Key Inclusion

  • Locally advanced or metastatic NSCLC with progression after all available therapies
  • Prior anti-PD-(L)1 exposure for at least 6 weeks with disease progression
  • One lesion suitable for repeat biopsy
  • Measurable disease per RECIST v1.1
  • ECOG performance status 0 or 1
  • Adequate organ and marrow function
  • Treated brain metastases allowed if stable without steroids for ≥7 days
  • Willing to undergo mandatory biopsies and blood collections

Key Exclusion

  • Active autoimmune disease or requiring systemic immunosuppression
  • History of interstitial lung disease or checkpoint inhibitor-induced pneumonitis
  • Required permanent discontinuation of prior ICI due to immune-related adverse events
  • Pregnant or breastfeeding
  • Active hepatitis B or C infection
  • Significant cardiovascular disease or stroke within 3 months
  • Unrecovered toxicities >Grade 1 from prior anticancer therapy
  • Receiving other investigational agents

NCT07102212

Randomized Clinical Trial of a Telemedicine-mHealth Symptom Cluster Intervention for Advanced Cancer Patients: Increasing Access in Rural Areas

Organization/Sponsor: Ohio State University Comprehensive Cancer Center


Example patient: A 62-year-old English-speaking woman with stage IV breast cancer experiencing moderate insomnia and fatigue, who uses email regularly and has an ECOG performance status of 1.

Phase N/A

Interventions

  • Behavioral: mHealth Intervention
    Summary: Mobile technology-based intervention using telemedicine to manage symptom clusters including insomnia, depression, anxiety, and fatigue in advanced cancer patients, offering personalized support and tracking (Web Search, NCI Thesaurus).

Key Inclusion

  • Advanced cancer (stage IIIb/c or IV lung, stage IV breast, stage IV prostate, advanced multiple myeloma, stage IIIb/IV melanoma)
  • Age 18 years or older
  • Able to read and write in English
  • Use internet and email
  • Meet clinical cut-offs on at least two symptoms: insomnia (ISI ≥8), depression (PHQ-2 ≥3), anxiety (GAD-2 ≥2), or fatigue (FSI ≥3)

Key Exclusion

  • Night-shift work
  • Untreated bipolar disorder
  • Substance use disorder
  • Cognitive impairment
  • ECOG performance status 3 or greater (in bed 50% or more of day)
  • Less than 6 months predicted survival

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, ECOG 1, with stable disease after 4 cycles of pembrolizumab, adequate organ function, and no autoimmune conditions.

Phase 1

Interventions

  • Biological: Pembrolizumab
    Summary: Pembrolizumab is a humanized IgG4 monoclonal antibody that blocks PD-1 receptor on T cells, preventing binding of PD-L1 and PD-L2, thereby enhancing immune-mediated tumor destruction. FDA-approved for multiple cancers including NSCLC and head and neck cancers. Source: FDA label, NCI Thesaurus.
  • Biological: PANDA-VAC
    Summary: PANDA-VAC is a personalized cancer vaccine targeting patient-specific tumor neoantigens to stimulate adaptive immune response against cancer cells. Designed to enhance tumor-specific T-cell immunity in lung cancer patients. Source: Summary of Web Search.

Key Inclusion

  • Previously treated squamous NSCLC or head and neck squamous cell carcinoma where cure not possible
  • Stable disease, mixed response, oligoprogressive or non-threatening progression on PD-1/PD-L1 therapy
  • NSCLC with PD-L1 TPS ≥1% and no EGFR or ALK aberrations, or progression on targeted therapy if aberrations present
  • SCCHN with PD-L1 CPS ≥1% for first-line or progression on platinum chemotherapy for non-first-line
  • ECOG performance status ≤1 for vaccine generation, ≤2 for vaccination
  • Adequate bone marrow function: ANC ≥1.5, ALC ≥1.0 for generation or ≥0.5 for vaccination
  • Measurable disease per RECIST 1.1 and iRECIST
  • Age ≥18 years

Key Exclusion

  • Active CNS metastases requiring treatment, leptomeningeal disease excluded
  • Systemic corticosteroids ≥10mg prednisone daily or other immunosuppressive medications
  • Known HIV, HCV, or active HBV infection
  • Active autoimmune disease requiring systemic treatment in past 2 years
  • History of organ transplant, bone marrow transplant, or stem cell transplantation
  • Active additional malignancy requiring treatment except basal/squamous skin cancer or in situ cervical cancer
  • Pregnant or breastfeeding
  • Live attenuated vaccines within 30 days of pembrolizumab dosing

NCT07357597

A Phase IV, Open-Label, Single-Arm Study of Prophylaxis for Datopotamab Deruxtecan-related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer (TROPION-SWISH) Genomic-based

Organization/Sponsor: AstraZeneca


Example patient: A 62-year-old woman with metastatic HR+/HER2- breast cancer, ECOG 1, who progressed on prior endocrine therapy and chemotherapy, with no active oral lesions and adequate bone marrow function.

Phase 4

Interventions

  • Drug: Datopotamab Deruxtecan (Dato-DXd)
    Summary: Trop-2-directed antibody-drug conjugate combining humanized monoclonal antibody with topoisomerase I inhibitor payload DXd, inducing DNA damage and selective tumor cell death in Trop-2-expressing cancers including HR+/HER2- breast cancer and EGFRm NSCLC (FDA label, NCI Thesaurus).
  • Drug: Dexamethasone mouthwash
    Summary: Corticosteroid mouthwash used prophylactically to reduce oral inflammation and prevent chemotherapy-induced stomatitis during Dato-DXd administration (Web Search).

Key Inclusion

  • Unresectable or metastatic HR+/HER2- breast cancer with prior endocrine therapy and chemotherapy
  • Unresectable or metastatic TNBC not candidates for PD-1/PD-L1 inhibitor therapy
  • Locally advanced or metastatic EGFRm NSCLC with prior EGFR-directed therapy and platinum-based chemotherapy
  • Age ≥18 years
  • ECOG performance status 0 or 1
  • Adequate bone marrow function (hemoglobin ≥9 g/dL)
  • Willing to comply with prophylactic dexamethasone mouthwash
  • Negative serum pregnancy test for women of childbearing potential

Key Exclusion

  • Prior receipt of Dato-DXd
  • Active and uncontrolled stomatitis or mouth ulcers at baseline
  • Active oral infections where steroid mouthwash is contraindicated
  • Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
  • Clinically significant corneal disease
  • History of severe hypersensitivity to Dato-DXd or monoclonal antibodies
  • Pregnant or breastfeeding
  • Cardiac, pulmonary, vascular, or renal conditions making participation undesirable

NCT07408531

LUNG-07: Advancing Precision-Based Lung Cancer Screening: Implementation, AI-Guided Risk Stratification, and Biomarker Integration (CREST AI)

Organization/Sponsor: University of Illinois at Chicago


Example patient: A 62-year-old former smoker with 30 pack-year history who quit 10 years ago, scheduled for low-dose CT screening at UI Health with no prior lung cancer diagnosis.

Phase N/A

Interventions

  • Device: Sybil Artificial Intelligence (AI) screening
    Summary: Sybil is an AI tool using deep learning to predict lung cancer risk from a single low-dose CT scan, aiming to improve screening accuracy and early detection outcomes in diverse populations (Web Search).

Key Inclusion

  • Age 50-80 years
  • ≥20 pack-years smoking history
  • Currently smoke or quit ≤15 years ago (USPSTF) or no restriction on quit time (ACS)
  • Receiving or scheduled for LDCT through UI Health Lung Screening Program
  • Willing to view educational video and complete Sybil AI survey
  • Able to provide informed consent
  • Women of childbearing potential must have negative pregnancy test

Key Exclusion

  • Inability to undergo LDCT
  • Current diagnosis or history of lung cancer <5 years prior
  • Life expectancy <1 year
  • Active lung infection requiring systemic therapy
  • Pregnant or nursing women
  • Prisoners or vulnerable populations
  • Mental or medical condition preventing informed consent

NCT07146568

Evaluating the Implementation and Effectiveness of the Pink and Pearl Campaign on Lung Cancer Screening at Christian Hospital

Organization/Sponsor: Washington University School of Medicine


Example patient: A 62-year-old English-speaking woman with a 25 pack-year smoking history who quit 5 years ago, presenting for routine screening mammography at Christian Hospital without symptoms or prior lung cancer.

Phase N/A

Interventions

  • Behavioral: Pink and Pearl Campaign
    Summary: A public health communication campaign targeting breast and lung cancer awareness through television, radio, newspapers, pamphlets, and telephone to improve lung cancer screening uptake among eligible women (NCI Thesaurus, Web Search).

Key Inclusion

  • Undergoing screening mammography at Christian Hospital
  • Between the ages of 50-80 years
  • 20 pack-year smoking history or quit within past 15 years
  • Can speak and understand English
  • Willing and able to get treatment if lung cancer is found

Key Exclusion

  • Previous history of lung cancer
  • Symptoms of lung cancer such as hemoptysis
  • Unexplained weight loss of more than 6.8 kg (15 lb) in previous year
  • Serious health problem limiting life expectancy

NCT07325136

A Phase 1/2 Study of BMS-986525 as Monotherapy and in Combination With Nivolumab in Participants With Relapsed/Refractory Small Cell Lung Cancer

Organization/Sponsor: Bristol-Myers Squibb


Example patient: A 62-year-old patient with relapsed small cell lung cancer after platinum-based chemotherapy, no brain metastases, and no history of autoimmune disease or organ transplant.

Phase 1, Phase 2

Interventions

  • Biological: Nivolumab
    Summary: A fully human IgG4 monoclonal antibody that blocks PD-1 receptor, preventing binding to PD-L1 and PD-L2, thereby activating T-cells and enhancing immune response against tumor cells (FDA label, NCI Thesaurus).
  • Drug: BMS-986525
    Summary: An experimental agent being studied in small cell lung cancer as monotherapy and in combination with Nivolumab; mechanism of action not publicly disclosed (Summary of Web Search).

Key Inclusion

  • Histologically or cytologically documented relapsed/refractory small cell lung cancer
  • Received at least 1 platinum-based chemotherapy regimen
  • Progressed on, ineligible for, or no access to anti-PD-(L)1 therapy where it is standard first-line treatment

Key Exclusion

  • Untreated CNS metastases
  • Active, known or suspected autoimmune disease
  • Prior organ or tissue allograft

NCT07428044

A Phase II Trial of Neoadjuvant Trastuzumab Deruxtecan for Patients With Stage II-III HER2-Amplified or HER2-Mutated Non-Small Cell Lung Cancer (HERCULES) Genomic-based

Organization/Sponsor: Memorial Sloan Kettering Cancer Center


Example patient: A 62-year-old never-smoker with ECOG 1, stage IIIA NSCLC harboring HER2 exon 20 mutation confirmed by tissue biopsy, deemed resectable by thoracic surgeon with LVEF 55% and adequate pulmonary function.

Phase II

Interventions

  • Drug: Trastuzumab Deruxtecan
    Summary: Antibody-drug conjugate targeting HER2-positive cells to deliver chemotherapy directly to cancer cells, studied for HER2-mutated or amplified NSCLC to improve survival and delay progression (Web Search).

Key Inclusion

  • Age ≥18 years with pathologically documented NSCLC
  • Stage II, IIIA, or selected IIIB (T3N2 or T4 by size) NSCLC per AJCC 8th edition
  • HER2 mutation or amplification (≥4 copies) confirmed by CLIA-certified laboratory
  • Measurable disease per RECIST v1.1
  • Technically completely resectable and medically operable per attending surgeon
  • LVEF ≥50% within 28 days before enrollment
  • ECOG Performance Status 0 or 1
  • Adequate hematologic function: ANC ≥1500/uL, platelets ≥100,000/uL, hemoglobin ≥9.0 g/dL

Key Exclusion

  • T4 by mediastinal organ invasion or N3 disease
  • Requires total pneumonectomy for complete resection
  • Any previous lung cancer therapy within 3 years
  • History of ILD or pneumonitis requiring steroids or current suspected ILD
  • Autoimmune or connective tissue disorders with pulmonary involvement
  • Corrected QT interval >470 msec (women) or >450 msec (men)
  • Active HIV, hepatitis B or C infection
  • Other malignancies within 3 years except low-risk cancers

NCT07168993

Detection of Early-Stage Lung Cancer in Sputum Using Flow Cytometry and an Automated Analysis Pipeline

Organization/Sponsor: bioAffinity Technologies Inc.


Example patient: A 62-year-old former smoker with 30 pack-year history who quit 8 years ago, recently found to have a new 12 mm solid lung nodule on screening CT scan.

Phase N/A

Interventions

  • Standard of Care: Standard medical treatment
    Summary: Standard medical treatment for lung cancer includes surgery, chemotherapy, radiation therapy, targeted therapies, or immunotherapies depending on stage and type, serving as a benchmark for comparing new treatments (Source: Web Search).

Key Inclusion

  • Age 50-80 years
  • Current or former smoker with ≥20 pack-year history
  • Former smokers quit within past 15 years
  • Lung nodule >6 to <30 mm diameter on CT scan
  • Nodule is new, increasing, or stable ≤6 months
  • Able to provide sputum sample within 6 weeks of baseline CT
  • High risk for lung cancer
  • Willing to provide contact information for follow-up

Key Exclusion

  • Unable to produce sputum sample
  • Dominant nodule is ground glass or part solid
  • Five or more nodules sized >4 mm
  • Distal endobronchial or perifissural nodule
  • Immunosuppressed or has rheumatoid arthritis
  • Lung cancer diagnosis in past 5 years
  • Any other cancer (except non-melanoma skin cancer) in past 2 years
  • Currently pregnant or planning pregnancy

NCT07323641

A Phase II Trial of Telisotuzumab Vedotin With Osimertinib for EGFR Mutated NSCLC With c-MET Overexpression That is Progressing on Osimertinib Genomic-based

Organization/Sponsor: Jonsson Comprehensive Cancer Center


Example patient: A 62-year-old woman with metastatic lung adenocarcinoma harboring EGFR exon 19 deletion and c-MET overexpression at 40%, ECOG 1, who progressed after 14 months on osimertinib with no brain metastases or neuropathy.

Phase II

Interventions

  • Drug: Telisotuzumab Vedotin
    Summary: Antibody-drug conjugate combining humanized anti-c-Met antibody with MMAE microtubule-disrupting agent to deliver cytotoxic activity to c-Met-overexpressing tumor cells in advanced non-squamous NSCLC (FDA label).
  • Drug: Osimertinib
    Summary: Tyrosine kinase inhibitor targeting EGFR mutations in NSCLC, inhibiting cancer cell growth in patients with specific EGFR mutations (Web Search).
  • Procedure: Survey Administration
    Summary: Self-reported data collection to assess patient experiences, knowledge, anxiety, and trial participation willingness (NCI Thesaurus).
  • Procedure: Magnetic Resonance Imaging
    Summary: Noninvasive imaging using radiofrequency waves and magnetic fields to provide detailed internal organ pictures for diagnosis and monitoring (NCI Thesaurus).
  • Procedure: Computed Tomography
    Summary: X-ray imaging with computer reconstruction to create cross-sectional scans for detecting cancer spread and assessing treatment effectiveness (NCI Thesaurus).
  • Procedure: Biospecimen Collection
    Summary: Gathering tissue and fluid samples to analyze genetic and molecular features for understanding cancer mechanisms and developing targeted therapies (NCI Thesaurus).
  • Procedure: Biopsy Procedure
    Summary: Removal of tissue specimens or fluid for microscopic examination to establish diagnosis and determine cancer type (NCI Thesaurus).

Key Inclusion

  • Age ≥18 years with histologically confirmed NSCLC with activating EGFR mutation
  • Predominantly adenocarcinoma histology
  • Progressed on osimertinib as last systemic therapy
  • c-MET overexpression ≥25% by VENTANA MET SP44 assay from post-osimertinib specimen
  • Measurable disease per RECIST 1.1
  • ECOG performance status 0-1
  • Adequate organ function including ANC ≥1.5×10^9/L, platelets ≥100×10^9/L
  • Effective contraception for females of childbearing potential

Key Exclusion

  • Prior c-MET targeted antibody drug conjugate with microtubule toxin
  • Chemotherapy, immunotherapy, or investigational therapy within 3 weeks or 5 half-lives
  • Thoracic radiation ≥30 Gy within 6 months
  • Progressive or symptomatic brain metastases or leptomeningeal disease
  • History of idiopathic lung disease, drug-induced pneumonitis, or active pneumonitis
  • Major surgery within 4 weeks
  • Active infection requiring parenteral antimicrobials
  • Grade ≥2 neuropathy, corneal disorder, edema, lymphedema, ascites, or pleural effusion

NCT07227623

Randomized Trial of a Digital Health Intervention to Improve Physical Function and Wellness of Lung Cancer Survivors

Organization/Sponsor: Massachusetts General Hospital


Example patient: A 62-year-old Spanish-speaking patient with stage II NSCLC, ECOG status 1, starting adjuvant chemotherapy after surgery with no cognitive impairment.

Phase N/A

Interventions

  • Behavioral: Enhanced Usual Care
    Summary: Standard treatment including surgery, chemotherapy, radiation, and hormone therapy without specific targeted or novel interventions, serving as control in clinical trials (Web Search).
  • Digital Therapeutic: PROMOTE Digital Health App Intervention
    Summary: Digital therapeutic providing 10 sessions of health and wellness education to treat anxiety and depression symptoms related to cancer diagnoses in adult patients (NCI Thesaurus).

Key Inclusion

  • Age ≥ 18 years
  • Stage I-III non-small cell lung cancer
  • Within six weeks of initiating curative treatment with chemotherapy ± immunotherapy
  • Neo-adjuvant or adjuvant setting with surgery or definitive chemoradiation
  • ECOG Performance Status 0-2
  • Ability to use digital health intervention in English
  • Ability to complete questionnaires in English or Spanish

Key Exclusion

  • Significant uncontrolled psychiatric disorder
  • Dementia or cognitive impairment prohibiting study participation

NCT07282444

Collaborative Oncology Between Radiologists and Radiation Oncologists for the Evaluation of Contoured Targets (CORRECT)

Organization/Sponsor: Wake Forest University Health Sciences


Example patient: A 62-year-old English-speaking patient with stage III non-small cell lung cancer planned for curative intent definitive chemoradiation at a community practice using PACS software.

Phase N/A

Interventions

  • Procedure: Electronic Health Record Review
    Summary: Checking and assessing patient data in electronic health records to improve care delivery and outcomes (NCI Thesaurus).
  • Behavioral: Interview
    Summary: Qualitative conversation to gather professional details, opinions, and experiences from radiation oncologists and radiologists regarding collaboration practices (NCI Thesaurus).
  • Behavioral: Survey Administration
    Summary: Presentation of questionnaires to obtain self-reported data on experiences and practices from study participants (NCI Thesaurus).
  • Behavioral: Communication Intervention
    Summary: Intervention to improve information exchange between radiologists and radiation oncologists regarding radiation therapy target contouring (NCI Thesaurus).
  • Behavioral: Training and Education
    Summary: Fifteen-minute mandatory virtual CORRECT training providing theory and hands-on experience for collaborative target evaluation (NCI Thesaurus).

Key Inclusion

  • Any stage clinically diagnosed lung or head and neck cancer
  • Planned curative intent definitive radiation therapy
  • Age 18 years or older
  • Practice treats at least 3 lung or head and neck cancer patients per month
  • Radiation oncologist and radiologist in independent practice for minimum six months
  • Use of PACS software at practice
  • Willing to participate in 15-minute virtual CORRECT training
  • Radiologist agrees to review pre-treatment radiation therapy targets

Key Exclusion

  • Early glottic larynx cancer planned for definitive RT alone
  • Unable to understand English or Spanish
  • Radiation oncologist or radiologist planning to leave position within 12 months
  • Temporary service providers (locum tenens)
  • Practice participation in another NCI NCORP CCDR U34-supported protocol funded in fiscal year 2025 or later

NCT07287995

A Phase 1b/2 Study of ASP2998 as Monotherapy and in Combination With Standard Therapies in Participants With Locally Advanced Unresectable or Metastatic Solid Tumors Genomic-based

Organization/Sponsor: Astellas Pharma Inc


Example patient: A 62-year-old with metastatic NSCLC adenocarcinoma without actionable mutations, PD-L1 positive, ECOG 1, who progressed after platinum-based chemotherapy and checkpoint inhibitor, seeking second-line treatment.

Phase 1, Phase 2

Interventions

  • Drug: ASP2998
    Summary: ASP2998 is an investigational agent being studied for HER2-positive and other solid tumors, modulating immune responses to enhance anti-tumor activity (source: Web Search).
  • Drug: Carboplatin
    Summary: Carboplatin is a platinum-based chemotherapy agent that forms DNA cross-links, inducing apoptosis in cancer cells; FDA-approved for ovarian carcinoma and used in various solid tumors (sources: FDA label, NCI Thesaurus).
  • Drug: Pembrolizumab
    Summary: Pembrolizumab is a humanized anti-PD-1 monoclonal antibody that blocks PD-1/PD-L1 interaction, enhancing T-cell-mediated immune responses against tumors; FDA-approved for multiple cancers including NSCLC and urothelial carcinoma (sources: FDA label, NCI Thesaurus).
  • Drug: Enfortumab Vedotin
    Summary: Enfortumab vedotin is a Nectin-4-directed antibody-drug conjugate delivering monomethyl auristatin E (MMAE) to induce microtubule disruption and apoptosis; FDA-approved for locally advanced or metastatic urothelial cancer (sources: FDA label, NCI Thesaurus).

Key Inclusion

  • Locally advanced unresectable or metastatic solid tumors (NSCLC, urothelial carcinoma, gastric/GEJ cancer, HER2-negative breast cancer)
  • ECOG performance status 0 or 1
  • At least one measurable lesion per RECIST v1.1
  • Life expectancy ≥12 weeks
  • Adequate organ function per laboratory values
  • NSCLC without actionable oncogenic alteration and known PD-L1 status
  • Urothelial carcinoma with <50% squamous differentiation allowed
  • Prior therapy requirements vary by cohort: 1L (no prior metastatic therapy) or 2L+ (≤3 prior lines)

Key Exclusion

  • Weight <40 kg
  • Active CNS metastases requiring glucocorticoids
  • History of Grade 4 adverse events or recurrent Grade 3 immune-related adverse events
  • Active autoimmune/inflammatory disorders requiring systemic therapy within 3 years
  • QTcF ≥470 msec or congenital long QT syndrome
  • Current Grade ≥1 interstitial lung disease/pneumonitis or history of non-infectious ILD
  • SpO2 <92% or chronic oxygen supplementation requirement
  • Peripheral neuropathy Grade ≥2 (for enfortumab vedotin or carboplatin cohorts)

NCT07169617

Evaluating the Feasibility of a Survivin Peptide Vaccine (SurVaxM) as an Interception Agent in Patients at High Risk for Lung Cancer

Organization/Sponsor: National Cancer Institute (NCI)


Example patient: A 62-year-old former smoker with 30 pack-year history, PLCO risk score of 2.1%, ECOG status 0, normal organ function, and no active malignancy or autoimmune disease.

Phase N/A

Interventions

  • Biological: SVN53-67/M57-KLH Peptide Vaccine
    Summary: A 15-mer peptide vaccine derived from survivin protein conjugated with KLH that activates cytotoxic T-lymphocyte and T-helper cell responses against survivin-expressing cancer cells. Survivin is upregulated in various cancers and associated with aggressive phenotype and chemotherapy resistance. Source: NCI Thesaurus.
  • Biological: Sargramostim
    Summary: Recombinant human granulocyte-macrophage colony-stimulating factor that boosts immune cell production to enhance immune response and support immunotherapy. Source: Summary of Web Search.
  • Procedure: Questionnaire Administration
    Summary: Collection of patient self-reported outcomes to assess quality of life and treatment effects. Source: NCI Thesaurus.
  • Drug: Montanide ISA 51 VG
    Summary: Water-in-oil emulsion immunoadjuvant that enhances cytotoxic T-lymphocyte response against vaccine antigens, containing vegetable-grade oleic acid from olive oil. Source: NCI Thesaurus.
  • Procedure: Biospecimen Collection
    Summary: Gathering of tissue and fluid samples for research to analyze genetic and molecular features. Source: NCI Thesaurus.

Key Inclusion

  • Former and current smokers with ≥20 pack year smoking history
  • PLCO m2012 Lung Cancer Risk Prediction Score >1.34%
  • Age ≥18 years
  • ECOG performance status ≤1
  • Platelets ≥100,000/microliter
  • Total bilirubin ≤1.5x ULN
  • AST/ALT ≤1.5x ULN
  • Serum creatinine ≤1.5x ULN

Key Exclusion

  • History of autoimmune disease requiring systemic immunosuppression
  • Current chemotherapy, immunotherapy, or investigational agents
  • Current or prior malignancy within 3 years except specified exceptions
  • History of allergic reactions to montanide or GM-CSF
  • Uncontrolled intercurrent illness or psychiatric conditions
  • Pregnant or breastfeeding women
  • Participation in another immunomodulatory interception trial within 6 months
  • Receiving systemic steroids or immunosuppressive agents

NCT06681220

Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC Genomic-based

Organization/Sponsor: VA Office of Research and Development


Example patient: A 62-year-old male veteran with extensive-stage SCLC, ECOG status 1, who progressed 8 months after first-line carboplatin/etoposide, with asymptomatic brain metastases and adequate organ function.

Phase N/A

Interventions

  • Drug: Lurbinectedin
    Summary: Lurbinectedin is an alkylating drug that covalently binds to DNA minor groove residues, causing DNA damage, delayed S phase progression, G2/M arrest, and cell death. FDA-approved for metastatic SCLC after platinum-based chemotherapy failure (accelerated approval). Source: FDA label, NCI Thesaurus.
  • Drug: Stenoparib/Temozolomide
    Summary: Stenoparib is a dual PARP and WNT pathway inhibitor combined with temozolomide, a DNA-alkylating agent, to enhance DNA damage response and block WNT signaling in relapsed small cell lung cancer. Source: Web Search Summary.

Key Inclusion

  • Age 18 years or older
  • Histological or cytological diagnosis of extensive-stage small cell lung cancer
  • One prior line of systemic therapy with Carboplatin and Etoposide
  • ECOG Performance status 0-2
  • Measurable disease per RECIST v1.1
  • Adequate bone marrow, liver, and renal function
  • Previously treated or asymptomatic brain metastases allowed
  • Patients who received Tarlatamab as second line treatment allowed

Key Exclusion

  • Prior exposure to lurbinectedin, temozolomide, or stenoparib
  • Pregnant or breastfeeding
  • Clinically significant acute infection requiring systemic therapy
  • Known history of myelodysplastic syndrome or acute myeloid leukemia
  • QTc interval >470 ms for females or >450 ms for males
  • Known hypersensitivity to Stenoparib components
  • Active clinically significant cardiovascular disease
  • Unstable concurrent medical condition jeopardizing safety or compliance

NCT07339059

Phase II Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer

Organization/Sponsor: Henry Ford Health System


Example patient: A 62-year-old male with extensive-stage small cell lung cancer and stable brain metastases, ECOG status 1, who completed 4 cycles of platinum-etoposide plus 3 cycles of atezolizumab without progression and adequate organ function.

Phase II

Interventions

  • Biological: Durvalumab
    Summary: Durvalumab is a PD-L1 blocking monoclonal antibody that enhances immune system recognition and attack of cancer cells by preventing PD-L1 binding to PD-1 on T-cells, indicated for small cell lung cancer and other malignancies (FDA label, NCI Thesaurus).
  • Biological: Atezolizumab
    Summary: Atezolizumab is a PD-L1 blocking monoclonal antibody that enhances T-cell-mediated immune response by preventing PD-L1 binding to PD-1 and B7.1, indicated for small cell lung cancer and other cancers (FDA label, NCI Thesaurus).
  • Biological: Sacituzumab govitecan
    Summary: Sacituzumab govitecan is an antibody-drug conjugate targeting Trop-2 that delivers a chemotherapy payload directly to cancer cells to induce cell death, used in metastatic non-small cell lung cancer (Summary of Web Search).

Key Inclusion

  • Histologically or cytologically confirmed small cell lung cancer (SCLC), extensive stage or locally advanced unable to receive curative radiation
  • At least four cycles of platinum plus etoposide and 2-3 cycles of atezolizumab or durvalumab
  • No evidence of progression on restaging CT after 4-6 cycles of chemo/IO
  • ECOG performance status 0-2
  • Stable and asymptomatic brain metastasis allowed
  • Adequate bone marrow, kidney, and liver function

Key Exclusion

  • Significant renal impairment requiring dialysis or end-stage liver disease
  • Leptomeningeal disease
  • Recent heart failure or acute coronary disease within 3 months
  • Unable to receive immunotherapy with chemotherapy or immunotherapy discontinued due to immune-related adverse events
  • Active chronic inflammatory bowel disease or gastrointestinal perforation within 6 months
  • Prior exposure to anti-PD-1, anti-PD-L1, anti-PD-L2, or CTLA-4 agents within 12 months