Sophic Logo gordian knotLung Cancer Clinical Trials Intelligence

Monthly Update Report for Trials Started in March 2026


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


Overview

Number of Trials: 28

These 28 trials investigate diverse therapeutic and diagnostic approaches for solid tumors, with a strong focus on lung cancer (NSCLC, SCLC, osteosarcoma pulmonary metastases). Immunotherapies dominate, including checkpoint inhibitors (PD-1/PD-L1, CTLA-4), bispecific antibodies, and novel combinations with targeted agents, chemotherapy, or radiation. Several trials explore antibody-drug conjugates (ADCs) targeting B7-H3, CLDN18.2, and MUC16. Emerging modalities include molecular glue degraders (ALK, KRAS G12C), MAT2A/PRMT5 inhibitors for MTAP-deleted tumors, and imaging agents (PET tracers, fluorescent dyes, AI-based risk models). Screening and early detection studies leverage AI, platelet RNA assays, and hyperpolarized xenon MRI. Trials span Phase 1 through Phase 3, enrolling patients with advanced, metastatic, or recurrent disease, often after standard-of-care failure.

Common Criteria Across Trials

Common Inclusion

  • Age ≥18 years
  • Histologically or cytologically confirmed advanced or metastatic solid tumor
  • Measurable disease per RECIST v1.1
  • ECOG performance status 0-1 (or 0-2)
  • Adequate organ function (bone marrow, liver, kidney)
  • Life expectancy ≥3 months (or ≥12 weeks)
  • Prior standard-of-care therapy or progression on prior lines
  • Willingness to provide tissue/blood samples for biomarker analysis
  • Effective contraception for participants of childbearing potential

Common Exclusion

  • Symptomatic or untreated brain metastases
  • Active autoimmune disease requiring systemic therapy
  • History of interstitial lung disease or pneumonitis
  • Significant cardiovascular disease (recent MI, CHF NYHA Class ≥II, uncontrolled arrhythmia)
  • Active infection requiring systemic therapy
  • Prior malignancy within 2-5 years (with exceptions)
  • Pregnancy or breastfeeding
  • HIV, hepatitis B, or hepatitis C infection (with active viral replication)
  • QTc prolongation >470-480 msec
  • Prior treatment with same class of investigational agent
  • Recent major surgery (within 14-28 days)
  • Use of strong CYP3A4 inhibitors/inducers or other interacting drugs

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


NCT06439914

IFN-y PET Imaging: Bench to Bedside

Organization/Sponsor: Barbara Ann Karmanos Cancer Institute


Example patient: A 62-year-old man with newly diagnosed stage IV non-small cell lung cancer, measurable 3 cm lung nodule on recent FDG PET, no prior immunotherapy, planning to start checkpoint inhibitor treatment.

Phase N/A

Interventions

  • Radioimmunoconjugate: [89Zr]Zr-DFO-emapalumab
    Summary: A PET imaging agent combining emapalumab (anti-IFN-gamma monoclonal antibody) with zirconium-89 radioisotope via DFO chelator to visualize interferon-gamma distribution, assess immune activation, and evaluate immunotherapy response (NCI Thesaurus).

Key Inclusion

  • Histologic or cytologic diagnosis of non-small cell lung cancer
  • FDG PET done within 2 months of baseline imaging
  • Measurable disease by RECIST 1.1 with at least one lesion ≥2 cm
  • Lesion in region imageable by PET outside of liver
  • Age >18 years
  • Able to lie still for imaging tests

Key Exclusion

  • Prior immunotherapy for current stage of NSCLC
  • Pregnant or breast feeding individuals
  • Immunotherapy in neoadjuvant/adjuvant setting with recurrence <12 months after completion

NCT07410117

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess Efficacy and Safety of REGN7508, a Monoclonal Antibody Against FXI, for Primary Prophylaxis of Cancer-Associated Thrombosis for Participants With Solid Tumors Undergoing Cancer Treatment (ROXI-CAT-I) Genomic-based

Organization/Sponsor: Regeneron Pharmaceuticals


Example patient: A 62-year-old woman with metastatic pancreatic adenocarcinoma, ECOG status 1, Khorana score of 3, no bleeding disorders or prior thrombosis, undergoing chemotherapy.

Phase 3

Interventions

  • Drug: REGN7508
    Summary: REGN7508 (cenvacibart) is a human IgG4 monoclonal antibody targeting Factor XI to prevent thrombosis. It binds FXI catalytic domain, blocking activation and reducing platelet and fibrin accumulation for cancer-associated thrombosis prophylaxis. Source: NCI Thesaurus.
  • Other: Placebo
    Summary: Placebo is an inactive compound identical in appearance to the active treatment, used to distinguish drug action from suggestive effects in controlled trials. Source: NCI Thesaurus.

Key Inclusion

  • Histologically confirmed malignant solid tumors, locally advanced or metastatic
  • Khorana thromboembolic risk score ≥2 at screening
  • Somatic tumor genetic variant associated with increased VTE risk
  • ECOG Performance Status 0 to 2

Key Exclusion

  • Known bleeding conditions (Hemophilia A or B, von Willebrand's disease)
  • Hemorrhagic tumor sites or high bleeding risk conditions
  • Basal cell or squamous cell skin carcinoma only
  • Primary brain tumor or brain metastases
  • History of VTE or ATE including incidental VTE requiring anticoagulation
  • Hepatic disease associated with coagulopathy

NCT07192900

Fast TILs to Treat Metastatic Cancer Patients With Pleural Disease: A Phase I Trial

Organization/Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)


Example patient: A 62-year-old patient with pleural mesothelioma and recurrent pleural effusions who has failed multiple lines of chemotherapy, has a Karnofsky score of 80, normal cardiac function, and no active infections.

Phase I

Interventions

  • Biological: Interleukin-2
    Summary: Recombinant interleukin-2 cytokine that stimulates T-cell activation and proliferation to enhance immune response against cancer cells, used in immunotherapy for metastatic melanoma and renal cell carcinoma (FDA label, NCI Thesaurus).
  • Biological: locally manufactured adoptive cellular therapy (ACT) product
    Summary: Allogeneic or autologous cell preparation with immunotherapeutic effect administered to patients, likely tumor-infiltrating lymphocytes expanded for adoptive transfer (NCI Thesaurus).

Key Inclusion

  • Symptomatic biopsy-proven malignant pleural disease or mesothelioma with pleural effusions
  • Refractory to or exhausted available standard of care therapy
  • Age 18 to less than 80 years
  • Cardiac ejection fraction ≥0.45
  • Karnofsky performance score ≥70
  • Expected survival >12 weeks
  • No supplemental oxygen requirement or dyspnea after effusion drainage

Key Exclusion

  • Breast, kidney, lung, pancreatic, prostate, ovarian, rare cancers, or melanoma
  • Active HIV, hepatitis B, or hepatitis C with viral replication
  • Active bacterial, fungal, or viral infection
  • Myocardial infarction within 6 months or symptomatic cardiac disease
  • Cytotoxic therapy or radiation within 2 weeks of effusion collection
  • Corticosteroid therapy >10mg prednisone equivalent within 2 weeks
  • Significant laboratory abnormalities including AST/ALT >2x ULN, creatinine >2x ULN
  • Prior solid organ transplantation

NCT07460440

SPARC - Screening for Lung Cancer With Platelets Via an AI-enabled RNA-based Classifier Genomic-based

Organization/Sponsor: University of Utah


Example patient: A 65-year-old treatment-naive patient with a newly identified 2 cm lung nodule on LDCT scan scheduled for biopsy within the next month, with no prior cancer history.

Phase N/A

Interventions

  • Diagnostic Test: Platelet RNA-based assay
    Summary: Analyzes RNA expression in platelets to detect lung cancer by identifying specific RNA signatures indicative of cancer progression using AI-enabled classification (Source: Web Search).

Key Inclusion

  • Aged 21 years or older
  • Diagnosed with any stage or type of lung cancer
  • Lung nodule identified on imaging within 180 days prior to enrollment
  • Planned biopsy, surgical resection, radiation, or systemic therapy for nodule evaluation
  • Control subjects aged 21 years or older

Key Exclusion

  • Other cancer diagnosis or treatment within last 6 months except non-melanoma skin cancer
  • History of lung cancer with definitive treatment within past 2 years
  • Currently receiving systemic therapy or radiation for lung cancer
  • Already undergone surgical resection of lung cancer
  • Invasive diagnostic or therapeutic procedures for lung nodule within past 3 months
  • Control subjects with active malignancy or cancer diagnosis within last 6 months
  • Control subjects with renal failure, liver failure, or decompensated heart failure
  • Unable to provide blood sample

NCT07154290

A Phase 2 Study to Investigate Ubamatamab With and Without REGN7075 in Treatment-Experienced Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Genomic-based

Organization/Sponsor: Regeneron Pharmaceuticals


Example patient: A 62-year-old with stage IV NSCLC and ECOG status 1, previously treated with platinum-based chemotherapy and anti-PD-1 therapy over 6 months ago, with MUC16-positive tumor tissue and measurable lung lesions.

Phase 2

Interventions

  • Biologic: Sarilumab
    Summary: Human monoclonal antibody blocking IL-6 receptor to inhibit IL-6-mediated inflammation, FDA-approved for rheumatoid arthritis and related conditions (FDA label, NCI Thesaurus).
  • Biologic: REGN7075
    Summary: Bispecific antibody targeting EGFR and CD28 to activate and redirect cytotoxic T-cells against EGFR-expressing tumor cells (NCI Thesaurus).
  • Biologic: Ubamatamab
    Summary: Bispecific human monoclonal antibody targeting CD3 and MUC16 to cross-link T-cells with MUC16-expressing tumor cells, inducing cytotoxic T-lymphocyte response (NCI Thesaurus).

Key Inclusion

  • Histologically or cytologically confirmed advanced (stage IIIB/IIIC) or metastatic (stage IV) NSCLC
  • Received appropriate first line standard of care treatment for advanced or metastatic NSCLC
  • Platinum doublet chemotherapy administered unless documented reason it is not appropriate
  • Tumor tissue available for MUC16 expression testing by immunohistochemistry
  • At least 1 radiographically measurable lesion by CT or MRI per RECIST v1.1
  • ECOG performance status of 0 or 1

Key Exclusion

  • Disease progression fewer than 84 days from starting initial anti-PD-(L)1 therapy
  • Unresolved treatment-related toxicity above grade 1 (except alopecia, hearing loss, grade 2 neuropathy, managed endocrinopathy)
  • Untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression
  • Participation in investigational study within 4 weeks before first dose
  • Prior monoclonal antibody against PD-(L)1 within 21 days of first dose
  • Prior anti-cancer immunotherapy within 21 days
  • Prior cytotoxic chemotherapy within 21 days
  • Anti-EGFR antibody therapy within drug-specific window (approximately 5 half-lives)

NCT07454642

A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6103, a Novel FAP-activated Exatecan Administered Intravenously in Subjects With Locally Advanced or Metastatic Selected Solid Tumors Genomic-based

Organization/Sponsor: Avacta Life Sciences Ltd


Example patient: A 62-year-old woman with metastatic FAP-positive pancreatic ductal adenocarcinoma, ECOG 1, who has progressed on gemcitabine-based chemotherapy and declines further standard treatment, with adequate organ function and no CNS metastases.

Phase 1

Interventions

  • Drug: AVA6103
    Summary: AVA6103 is a FAP-activated prodrug delivering exatecan, a topoisomerase 1 inhibitor payload, targeting fibroblast activation protein-positive tumors in advanced solid cancers including pancreatic, gastric, cervical, vulvar, and small cell lung cancer (Web Search).

Key Inclusion

  • Age ≥18 years
  • FAP-positive cervical/vulvar, SCLC, gastric/GEJ, or PDAC with locally advanced unresectable and/or metastatic disease
  • Received all standard-of-care or FDA-approved treatments, ineligible, or declined those treatments
  • Life expectancy ≥3 months
  • ECOG performance status 0 or 1
  • Adequate hematological function: ANC ≥1.5×10⁹/L, hemoglobin ≥9.0 g/dL, platelets ≥100,000/µL
  • Adequate liver function: bilirubin ≤1.5×ULN, AST/ALT ≤2.5×ULN (≤5×ULN with liver metastases)
  • Creatinine clearance ≥60 mL/min by Cockcroft-Gault

Key Exclusion

  • Active or suspected CNS metastases unless definitively treated, asymptomatic, and stable ≥4 weeks
  • Active other malignancy within 2 years
  • HIV with AIDS-defining infection within 12 months or viral load >400 copies/mL
  • Active HBV (HBsAg positive) or HCV infection
  • Severe infection requiring IV antibiotics within 21 days
  • Major surgery within 21 days prior to Cycle 1 Day 1
  • QTcF >470 ms on ECG
  • Concurrent strong CYP3A4, CYP1A2, CYP2D6, or P-gp inhibitors/inducers

NCT07322367

A Pragmatic Randomized-Controlled Learning Health System Trial

Organization/Sponsor: Wake Forest University Health Sciences


Example patient: A 62-year-old current smoker with 30 pack-year history, established with a primary care provider in North Carolina, with a patient portal account and no prior lung cancer or recent chest CT.

Phase N/A

Interventions

  • Behavioral: Usual Care
    Summary: Standard care without additional experimental interventions for promoting lung cancer screening (Summary of Web Search).
  • Behavioral: Portal message only
    Summary: Informational messaging via healthcare portal to promote awareness and encourage lung cancer screening participation (Summary of Web Search).
  • Behavioral: Text Message with Reminder Text Messages
    Summary: Short electronic communications sent to mobile phones to remind and encourage screening (NCI Thesaurus).
  • Behavioral: Portal Message with Reminder Text Messages
    Summary: Text message-based system guiding patients through screening procedures to improve engagement and compliance (NCI Thesaurus).

Key Inclusion

  • Age 50-77 years
  • Smoked at least 20 pack years
  • Current smoker or quit within past 15 years
  • Established with primary care provider in Atrium Health Wake Forest Baptist network
  • Patient portal account or cellphone number in electronic health record
  • North Carolina address in electronic health record

Key Exclusion

  • Requires language interpreter other than Spanish
  • Prior history of lung cancer
  • Chest CT within last 12 months
  • Meets HEDIS COL-E exclusion criteria for significant comorbidities or frailty

NCT07354919

A Phase II Trial of Cancer Response Using Axelopran in Patients With Advanced Cancers on Opioids (AxeCan)

Organization/Sponsor: HealthPartners Institute


Example patient: A 62-year-old man with metastatic castrate-resistant prostate cancer progressed on enzalutamide and docetaxel, currently taking 10mg oral morphine equivalents daily for bone pain, with measurable lymph node metastases and life expectancy of 6 months.

Phase II

Interventions

  • Drug: axelopran
    Summary: Axelopran is an investigational agent being studied for cancer control in phase II trials; its specific mechanism of action has not been publicly disclosed (Source: Web Search).

Key Inclusion

  • Adults aged 18 or more with histologically or cytologically proven prostate, breast, pancreatic carcinoma, or NSCLC
  • Advanced stage (locally advanced or metastatic) with no curative-intent therapy planned
  • Relapsed or progressed on or after standard systemic treatment including cytotoxic chemotherapy
  • Current opioid use averaging at least 5mg OME/day over past 3 days
  • Minimum life expectancy of at least 2 months
  • At least one measurable lesion meeting RECIST v1.1 criteria
  • At least 2 weeks since last cancer-directed therapy
  • Willing to delay next line of systemic therapy until day 43 for imaging assessment

Key Exclusion

  • Previous gastrointestinal surgery except uncomplicated appendectomy or cholecystectomy
  • Active malignancy with direct GI tract invasion or metastasis
  • Current active untreated brain metastases
  • History of fecal incontinence, inflammatory bowel disease, or intestinal obstruction
  • Use of buprenorphine, alvimopan, naltrexone, methylnaltrexone, naloxone, or related therapies within 14 days
  • Receipt of strong CYP3A4 inhibitors or inducers within 14 days or 5 half-lives
  • Receipt of anti-VEGF therapies within 30 days
  • Pregnant, breastfeeding, or women of childbearing potential without birth control

NCT07224152

NBTXR3 With Radiation Therapy Alone for Locally-advanced Non-small Cell Lung Cancer

Organization/Sponsor: M.D. Anderson Cancer Center


Example patient: A 72-year-old with ECOG 1, stage III NSCLC deemed medically inoperable due to poor pulmonary function, no prior lung radiation, and adequate organ function who is eligible for bronchoscopic NBTXR3 injection followed by radiation therapy.

Phase N/A

Interventions

  • Device/Nanoparticle: NBTXR3
    Summary: Hafnium oxide nanoparticle suspension injected into tumors that amplifies radiation therapy by emitting electrons when exposed to radiation beams, generating free radicals that destroy cancer cells with improved efficiency compared to standard radiotherapy (NCI Thesaurus).

Key Inclusion

  • Biopsy proven stage I-III NSCLC
  • Medically inoperable or patient declines surgery
  • ECOG Performance Status 0-2
  • Age ≥18 years
  • Amenable to bronchoscopic or CT-guided injection of NBTXR3
  • Up to 4 lung lesions may be injected including primary tumor and lymph nodes
  • Target lesions measurable on imaging (RECIST 1.1)
  • May receive up to 1 line of prior systemic therapy

Key Exclusion

  • Unable to undergo NBTXR3 injection or radiation therapy
  • Pregnant or breastfeeding
  • History of interstitial lung disease or drug-related pneumonitis
  • Prior radiation therapy to lung or intrathoracic organs
  • More than 1 line of prior systemic therapy
  • Concurrent systemic therapy or participation in another therapeutic trial
  • Active malignancy with exceptions for definitively treated cancers
  • Uncontrolled infection or intercurrent illness

NCT06492954

Phase 1b Trial of Atezolizumab in Combination With Stereotactic Body Radiation Therapy (SBRT) and Surgery in Patients With Pulmonary Recurrence of Osteosarcoma

Organization/Sponsor: Emory University


Example patient: A 14-year-old with first relapse of osteosarcoma presenting with three resectable bilateral lung nodules (largest 8 mm), Lansky score 80, adequate organ function, and no extrapulmonary disease.

Phase 1

Interventions

  • Biological: Atezolizumab
    Summary: Humanized monoclonal antibody blocking PD-L1 to enhance T-cell immune response against tumors; FDA-approved for multiple cancers including NSCLC and SCLC; Fc-optimized to avoid ADCC/CDC (FDA label, NCI Thesaurus).
  • Radiation: Stereotactic Body Radiation Therapy (SBRT)
    Summary: High-precision radiation delivering maximum dose to body tumors while sparing healthy tissue; effective for early-stage and metastatic lung cancers (NCI Thesaurus, Web Search).
  • Procedure: Surgical Resection
    Summary: Surgical removal of tumor tissue aiming for complete excision to improve survival; often combined with adjuvant therapies in pediatric cancers (NCI Thesaurus, Web Search).

Key Inclusion

  • Histologically verified osteosarcoma in first or greater relapse
  • Recurrence limited to lung (unilateral or bilateral)
  • All pulmonary nodules resectable without pneumonectomy
  • At least 1 lesion ≥5 mm eligible for SBRT plus additional nodule(s) requiring resection
  • Karnofsky/Lansky score ≥60 or ECOG ≤2
  • Adequate organ function (bone marrow, renal, hepatic, cardiac, pulmonary)
  • Life expectancy ≥4 months
  • Effective contraception required for sexually active patients

Key Exclusion

  • Active extrapulmonary metastatic disease (bone, CNS, other sites)
  • Prior lung radiation
  • Active autoimmune disorder requiring systemic treatment in past 12 months
  • Significant cardiovascular disease within 3 months
  • Current or prior pneumonitis
  • Chronic immunosuppressive therapy or uncontrolled infection
  • Prior allogeneic stem cell or solid organ transplant
  • HIV, hepatitis B, or hepatitis C infection

NCT07361510

ROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With PD-L1 ≥ 50%. Genomic-based

Organization/Sponsor: Bristol-Myers Squibb


Example patient: A 62-year-old with Stage IV nonsquamous NSCLC, PD-L1 expression 70%, ECOG status 1, no actionable genomic alterations, no prior systemic therapy, and no autoimmune disease or CNS metastases.

Phase 3

Interventions

  • Bispecific Antibody: Pumitamig
    Summary: Pumitamig is a bispecific antibody targeting PD-L1 and VEGF-A to enhance immune response and vascular normalization, showing promise in cancer immunotherapy (Summary of Web Search).
  • Monoclonal Antibody: Pembrolizumab
    Summary: Pembrolizumab is a humanized IgG4 monoclonal antibody blocking PD-1 receptor, enhancing T-cell-mediated immune responses against tumors; FDA-approved for multiple cancers including NSCLC (FDA label, NCI Thesaurus).

Key Inclusion

  • Histologically or cytologically confirmed NSCLC (squamous and nonsquamous)
  • Stage IIIB/IIIC or Stage IV disease
  • PD-L1 expression ≥ 50%
  • Measurable disease by RECIST v1.1
  • No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC
  • ECOG Performance Status 0-1

Key Exclusion

  • Documented actionable genomic alteration with first-line approved therapies indicated
  • Symptomatic untreated CNS metastases, leptomeningeal metastases, or spinal cord compression
  • Significant cardiovascular impairment including uncontrolled hypertension or recent cardiac events
  • Active coronary disease within 6 months prior to randomization
  • Major thrombotic, embolic, or hemorrhagic events within 6 months
  • Significant risk of pulmonary hemorrhage
  • Active autoimmune disease

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 quit time restriction (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 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

NCT07355205

A Phase II, Single-Center, Open-Label Study of First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer (FLINN) Genomic-based

Organization/Sponsor: Washington University School of Medicine


Example patient: A 62-year-old with ECOG 1, newly diagnosed metastatic NSCLC without EGFR/ALK/ROS1 mutations, adequate organ function, and no active autoimmune disease or recent systemic corticosteroid use.

Phase II

Interventions

  • BLA: Nogapendekin alfa inbakicept
    Summary: An IL-15 receptor agonist fusion protein that activates NK cells, CD8+ T-cells, and memory T-cells to enhance immune response against tumor cells (FDA label, NCI Thesaurus).
  • BLA: Nivolumab
    Summary: A PD-1 blocking monoclonal antibody that prevents PD-1/PD-L1 interaction, activating T-cells and enhancing immune response against cancer cells in NSCLC and other malignancies (FDA label, NCI Thesaurus).
  • BLA: Ipilimumab
    Summary: A CTLA-4 blocking monoclonal antibody that inhibits T-cell downregulation, enhancing cytotoxic T-lymphocyte immune response against cancer cells in multiple advanced cancers (FDA label, NCI Thesaurus).

Key Inclusion

  • Histologically or cytologically confirmed, previously untreated or recurrent metastatic NSCLC
  • At least 18 years of age
  • ECOG performance status ≤ 1
  • Measurable disease per RECIST 1.1
  • Adequate organ and marrow function
  • Availability of archival biopsy tissue or willingness to undergo biopsy for biomarker analysis
  • Brain metastases allowed if previously treated and neurologically stable after 2 weeks
  • Effective contraception required through 6 months after last dose

Key Exclusion

  • Tumor harboring EGFR mutation, HER2 mutation, ALK fusion, ROS1 fusion or RET fusion
  • Mixed histology including small cell lung cancer
  • Prior chemotherapy in adjuvant setting or during concurrent radiation within 12 months
  • Active autoimmune disease or history requiring systemic treatment in past 2 years
  • Concurrent use of supra-physiologic corticosteroids (>10 mg/day prednisone equivalent)
  • History of interstitial lung disease or noninfectious pneumonitis
  • Active infections requiring parenteral treatment within 14 days
  • Pregnant or breastfeeding

NCT07287085

Increasing Lung Cancer Screening Uptake Among Emergency Department Patients

Organization/Sponsor: University of Rochester


Example patient: A 62-year-old English-speaking current smoker with 30 pack-year history presenting to the University of Rochester Emergency Department with a text-capable phone and able to provide informed consent.

Phase N/A

Interventions

  • Behavioral: Basic Referral (enhanced control arm)
    Summary: Control arm intervention providing standard referral process for lung cancer screening without additional facilitation (NCI Thesaurus).
  • Behavioral: Facilitated referral and text messaging
    Summary: Enhanced intervention combining facilitated patient referral to screening services with text message reminders to improve lung cancer screening uptake (NCI Thesaurus).

Key Inclusion

  • Age 50-80 years
  • ≥20 pack-year smoking history
  • Current smoker or quit within 15 years
  • English speaking
  • Current patient in URMC Emergency Department
  • Text-capable mobile phone with ability to use text function

Key Exclusion

  • Non-English speaking
  • Inability to provide consent due to high clinical acuity
  • Cognitive deficit preventing consent
  • Lack of text-capable mobile phone
  • Inability to use text messaging function

NCT06909201

Hyperpolarized Xenon-129 Magnetic Resonance Imaging in Lung Cancer Patients Receiving Radiation Therapy for Investigating Radiation-response and Toxicity

Organization/Sponsor: M.D. Anderson Cancer Center


Example patient: A 62-year-old man with biopsy-confirmed lung cancer scheduled for proton beam radiotherapy at MD Anderson, able to hold his breath for 12 seconds and undergo MRI without claustrophobia.

Phase N/A

Interventions

  • Diagnostic imaging agent: HP 129Xe MRI
    Summary: Hyperpolarized xenon-129 gas is inhaled and distributed throughout the lungs, enhancing NMR signals for MRI visualization of lung structures and function to assess abnormalities (NCI Thesaurus).

Key Inclusion

  • Biopsy proven diagnosis of lung cancer
  • Receiving photon- or proton-based external beam radiotherapy
  • Able to consistently hold breath for 10-12 seconds
  • Able to undergo MRI examination
  • At least 18 years of age
  • Will receive follow-up at UTMDACC
  • Willing to sign informed consent
  • Women and men with child-bearing potential agree to use adequate contraception

Key Exclusion

  • Unable to follow up at MD Anderson for routine clinical care
  • Inability or unwillingness to give informed consent
  • Relapsed disease or life expectancy less than 6 months
  • Severe claustrophobia precluding MRI imaging
  • Active pulmonary infection
  • Pregnant women
  • Under 18 years of age

NCT07361497

ROSETTA Lung-201: A Randomized, Multicenter, Open-label Phase 3 Study of Pumitamig Monotherapy Compared to Durvalumab in Participants With Unresectable Stage III NSCLC Without Progression After Platinum-based Concurrent Chemoradiation Therapy. Genomic-based

Organization/Sponsor: Bristol-Myers Squibb


Example patient: A 62-year-old with unresectable Stage III squamous NSCLC, ECOG PS 1, who completed 4 cycles of platinum-based chemoradiotherapy with 60 Gy radiation without progression, no EGFR/ALK mutations, and no autoimmune or cardiovascular disease.

Phase 3

Interventions

  • Bispecific Antibody: Pumitamig
    Summary: Pumitamig is a bispecific antibody targeting PD-L1 and VEGF-A to enhance immune response and vascular normalization, showing promise in cancer immunotherapy (Web Search).
  • Monoclonal Antibody: Durvalumab
    Summary: Durvalumab is a PD-L1 blocking monoclonal antibody that enhances immune system recognition and attack of cancer cells, indicated for NSCLC consolidation after chemoradiotherapy (FDA label, NCI Thesaurus).

Key Inclusion

  • Histologically or cytologically confirmed NSCLC with unresectable Stage III disease
  • At least 2 cycles of platinum-based concurrent chemoradiotherapy
  • Total radiation dose of at least 54 Gy
  • No progressive disease following concurrent chemoradiotherapy
  • ECOG performance status 0 or 1

Key Exclusion

  • Non-squamous histology with documented EGFR or ALK rearrangements
  • Active autoimmune disease
  • Significant cardiovascular impairment or uncontrolled hypertension
  • Major thrombotic, embolic, or hemorrhagic events within 6 months
  • Advanced lung disease or history of interstitial lung disease or pneumonitis requiring systemic steroids
  • Current or suspected ILD or pneumonitis
  • Prior anticancer therapy outside of concurrent chemoradiotherapy for Stage III disease

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 chemotherapy, ECOG status 2, experiencing moderate dyspnea but clinically stable for four months without cardiac or acute pulmonary complications.

Phase N/A

Interventions

  • Behavioral: No intervention: Usual care
    Summary: Standard care for lung cancer including conventional chemotherapy regimens with cytotoxic action, without targeted or novel therapies (Summary of Web Search).
  • Behavioral: Pulmonary Rehabilitation (PR)
    Summary: Structured program combining exercise, education, and support to improve lung function, physical capacity, walking distance, and quality of life in lung cancer patients (Summary of Web Search).

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 mMRC Dyspnea Scale
  • Fluent in written and spoken English

Key Exclusion

  • Treatment with curative intent for locally advanced or oligometastatic NSCLC
  • Evidence of clinical or radiographic progression
  • Mental impairment preventing study completion
  • High risk of fracture or spine instability (Mirels ≥7 or SINS ≥7)
  • NYHA Class II-IV heart failure
  • Acute coronary syndromes or cardiac procedures within 6 months
  • Uncontrolled arrhythmias or syncope
  • Acute pulmonary embolus, thrombosis, or respiratory failure within 3 months

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 stable antihypertensive therapy.

Phase II

Interventions

  • Biologic: Ivonescimab 20 mg/kg
    Summary: Bispecific antibody targeting PD-1 and VEGF, combining immunotherapy and anti-angiogenesis to enhance T-cell activity and inhibit tumor vascularization in lung cancer treatment (Web Search).
  • Biologic: Ivonescimab 10 mg/kg
    Summary: Bispecific antibody targeting PD-1 and VEGF, combining immunotherapy and anti-angiogenesis, showing superior progression delay compared to PD-1 inhibitors alone in lung cancer trials (Web Search).

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 with fistula risk
  • Major surgical procedures or serious trauma within 28 days
  • Clinically significant bleeding symptoms or hemoptysis ≥0.5 teaspoon within 4 weeks
  • Cardiovascular events requiring hospitalization within 12 months
  • Poorly controlled hypertension (systolic ≥150 or diastolic ≥100 mmHg)
  • Active autoimmune or lung disease requiring systemic therapy within 2 years
  • Pre-existing peripheral neuropathy ≥Grade 2

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 1, who progressed after platinum-doublet chemotherapy and pembrolizumab, with no other driver mutations or prior KRAS inhibitor exposure.

Phase 1, Phase 2

Interventions

  • Drug: Olomorasib
    Summary: Olomorasib targets KRAS G12C mutations to enhance treatment efficacy in lung cancer, studied in combination with immunotherapy (Source: Web Search).
  • Biological: Amivantamab
    Summary: Amivantamab is a bispecific antibody targeting EGFR and MET receptors, inhibiting signaling and inducing immune-mediated tumor destruction in NSCLC with resistance mutations (Source: Web Search).

Key Inclusion

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

Key Exclusion

  • History of uncontrolled illness
  • Allergies or hypersensitivity to amivantamab or olomorasib excipients
  • Medical history of 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

NCT07488676

A Phase 1b/2 Open-label Study to Assess the Safety and Efficacy of ASP546C in Participants With CLDN18.2-expressing Locally Advanced Unresectable or Metastatic Gastroesophageal Adenocarcinoma, Pancreatic Adenocarcinoma or Other Solid Tumor Types Genomic-based

Organization/Sponsor: Astellas Pharma Inc


Example patient: A 62-year-old woman with CLDN18.2-positive metastatic gastric adenocarcinoma, HER2-negative, ECOG 1, who progressed after first-line chemotherapy with no brain metastases or significant cardiac history.

Phase 1, Phase 2

Interventions

  • Drug: ASP546C
    Summary: ASP546C is an antibody-drug conjugate targeting CLDN18.2-positive solid tumors. It delivers cytotoxic agents directly to cancer cells expressing CLDN18.2. Currently in Phase 3 trials for various malignancies including breast cancer. Source: Web Search Summary.

Key Inclusion

  • Histologically confirmed gastroesophageal, pancreatic, or pan-tumor adenocarcinoma (including NSCLC, SCLC, ovarian, breast, colorectal, cholangiocarcinoma)
  • Tumor expresses CLDN18.2
  • Radiologically confirmed unresectable locally advanced or metastatic disease
  • Received at least 1 prior line of therapy for advanced disease
  • ECOG performance status 0 or 1
  • Life expectancy ≥12 weeks
  • Measurable disease per RECIST v1.1 (Cohorts 1-3) or evaluable disease (Cohort 4)
  • Adequate laboratory parameters within 14 days of first dose

Key Exclusion

  • Non-adenocarcinoma or mixed histology (Cohorts 1-3)
  • >2 prior lines of therapy for advanced disease (Cohorts 1-3)
  • Symptomatic or untreated brain metastases
  • Active infection requiring systemic therapy within 7 days
  • Prior CLDN18.2 antibody-drug conjugate treatment
  • Significant cardiovascular disease or QTc >470 msec
  • Peripheral neuropathy >grade 1
  • HER2 positive status (gastroesophageal cohorts only)

NCT07491497

A Phase 1/2, Dose Escalation and Expansion Study of TRI-611, an Oral ALK Molecular Glue Degrader in Participants With Advanced ALK-Positive NSCLC Genomic-based

Organization/Sponsor: TRIANA Biomedicines, Inc.


Example patient: A 58-year-old with ALK-positive metastatic NSCLC previously treated with alectinib and lorlatinib (second line) with disease progression and measurable lung lesions.

Phase 1, Phase 2

Interventions

  • Drug: TRI-611
    Summary: TRI-611 is an investigational oral ALK-fusion molecular glue degrader that targets and degrades ALK fusion proteins in ALK-positive non-small cell lung cancer, with FDA Fast Track designation (Source: Web Search).

Key Inclusion

  • Pathologically confirmed ALK-positive NSCLC
  • Measurable disease per RECIST v1.1
  • Adequate bone marrow reserve and organ function
  • Part 1: prior treatment with 2-3 ALK TKIs including lorlatinib (not first line)
  • Part 2 Cohort M1: prior 2-3 ALK TKIs including lorlatinib, no neladalkib
  • Part 2 Cohort M2: more than 3 ALK TKIs including lorlatinib and neladalkib (neither first line)
  • Part 2 Cohort M3: no prior ALK TKI treatment

Key Exclusion

  • Additional driver alterations causing ALK TKI resistance
  • CNS metastases with progressive neurological symptoms
  • CNS disease requiring increasing corticosteroid doses
  • Ongoing anticancer treatment or investigational agent
  • Known allergy/hypersensitivity to TRI-611
  • Major surgery within 4 weeks

NCT07424547

Phase I Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SYS6043 in Patients With Advanced/Metastatic Solid Tumors

Organization/Sponsor: Conjupro Biotherapeutics, Inc.


Example patient: A 62-year-old man with metastatic colorectal cancer progressing after standard chemotherapy, ECOG 1, LVEF 55%, no cardiac or pulmonary comorbidities, and no prior B7-H3 targeted therapy.

Phase I

Interventions

  • Drug: SYS6043
    Summary: SYS6043 is an antibody-drug conjugate targeting B7-H3, a protein expressed in certain advanced tumors, delivering a cytotoxic payload to cancer cells expressing B7-H3 for treatment of advanced or metastatic solid tumors including breast cancer (Source: Web Search).

Key Inclusion

  • Aged ≥18 years old
  • Advanced/unresectable or metastatic solid tumors confirmed by histology or cytology
  • Disease recurrence or progression during or after standard of care
  • At least one measurable lesion per RECIST V1.1
  • Life expectancy ≥3 months
  • ECOG performance status 0-1
  • LVEF ≥50% by ECHO or MUGA

Key Exclusion

  • Prior B7-H3 targeted therapy
  • Previously received topoisomerase inhibitor antibody-drug conjugate
  • Symptomatic congestive heart failure (NYHA Class II-IV)
  • Mean QTcF >470 ms
  • History of interstitial lung disease or non-infectious pneumonia
  • Active and clinically significant bacterial, fungal, or viral infection
  • Pregnant or lactating women
  • Spinal cord compression or clinically active brain metastasis

NCT07146230

The Selective Personalized Radio-Immunotherapy for Locally Advanced NSCLC Trial 2 (SPRINT 2) Genomic-based

Organization/Sponsor: Montefiore Medical Center


Example patient: A 62-year-old man with newly diagnosed Stage III NSCLC, ECOG status 1, PD-L1 TPS 70%, no autoimmune disease, adequate organ function, and no prior cancer treatment.

Phase N/A

Interventions

  • Radiation: Radiotherapy
    Summary: High-energy beam radiation that kills or damages cancer cells in lung cancer, can induce ferroptosis, with resistance overcome by targeting DHODH enzyme (Summary of Web Search).
  • Biological: Oleclumab
    Summary: Monoclonal antibody against CD73 that prevents conversion of AMP to adenosine, reducing immunosuppression and enhancing CD8+ T-cell activity against tumors while decreasing cancer cell migration (NCI Thesaurus).
  • Biological: Monalizumab
    Summary: Anti-NKG2A monoclonal antibody targeting immune checkpoints that enhances cytotoxic T-cell and NK cell activity in lung cancer, studied in combination with other immunotherapies (Summary of Web Search).
  • Biological: Durvalumab
    Summary: PD-L1 blocking monoclonal antibody that enhances immune recognition of cancer cells, FDA-approved for multiple cancers including NSCLC after chemoradiotherapy, with monitoring required for immune-related adverse events (FDA label, NCI Thesaurus).

Key Inclusion

  • Previously untreated NSCLC, AJCC version 8 Stage II (medically/technically unresectable) or Stage III disease
  • PD-L1 tumor proportion score at least 50% by FDA-approved assay
  • Age >18 years, body weight ≥35 kg
  • ECOG performance status 0 or 1
  • Life expectancy at least 12 weeks
  • At least one hypermetabolic pulmonary lesion or thoracic lymph node on PET/CT
  • Adequate organ and marrow function (hemoglobin ≥9.0 g/dL, ANC ≥1.5×10⁹/L, platelets ≥75×10⁹/L)
  • Creatinine clearance >40 mL/min

Key Exclusion

  • Prior anti-PD-1 or anti-PD-L1 therapy with Grade ≥3 immune-related adverse events
  • Active or prior documented autoimmune or inflammatory disorders
  • History of leptomeningeal carcinomatosis or active brain metastases
  • Concurrent chemotherapy, biologic, or hormonal therapy for cancer
  • Active infection including hepatitis B, hepatitis C, HIV, or tuberculosis
  • Immunosuppressive medication within 14 days (except physiologic doses ≤10 mg/day prednisone equivalent)
  • History of myocardial infarction within 12 months or congestive heart failure ≥Class 3
  • Pregnant or breastfeeding, or not willing to use effective birth control

NCT07407933

A Phase Ib/II, Multicenter, Open-Label Study to Evaluate Safety, Efficacy, and Pharmacokinetics of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors

Organization/Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.


Example patient: A 62-year-old treatment-naive patient with extensive-stage small cell lung cancer, ECOG performance status 1, adequate organ function, no brain metastases, and no history of interstitial lung disease or significant heart failure.

Phase 1b, Phase 2

Interventions

  • Biologic: Atezolizumab
    Summary: A humanized PD-L1 blocking monoclonal antibody that enhances T-cell-mediated immune response against tumors by preventing PD-L1 binding to PD-1 and B7.1, indicated for multiple cancers including small cell lung cancer (FDA label, NCI Thesaurus).
  • Antibody-Drug Conjugate: YL201
    Summary: An anti-B7-H3 antibody-drug conjugate linked to a topoisomerase-1 inhibitor via a protease-cleavable linker, targeting B7-H3-expressing tumor cells to inhibit DNA replication and induce apoptosis (NCI Thesaurus).

Key Inclusion

  • 18 years of age or older
  • Histologically or cytologically confirmed diagnosis of ES-SCLC
  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • Adequate hematologic and end-organ function

Key Exclusion

  • No prior systemic anti-cancer treatment for ES-SCLC
  • No prior treatment targeting B7H3 or topoisomerase I inhibitor
  • No clinically active brain metastases or spinal cord compression
  • No current or history of interstitial lung disease or pneumonitis
  • No clinically significant cardiovascular disease (NYHA class II to IV congestive heart failure)

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 N/A

Interventions

  • Drug: IDE892
    Summary: IDE892 is a PRMT5 inhibitor that targets MTAP-deleted cancers by exploiting synthetic lethality in tumors lacking methylthioadenosine phosphorylase (Summary of Web Search).
  • Drug: IDE397
    Summary: IDE397 is an oral MAT2A inhibitor that blocks S-adenosyl-L-methionine synthesis, inhibiting proliferation in MTAP-deleted cancers dependent on this pathway (NCI Thesaurus).

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
  • Severe infections within 4 weeks prior to treatment
  • Uncontrolled hypertension >150/100 mmHg
  • Previous treatment with MAT2A or PRMT inhibitor
  • Strong CYP3A4/5 inhibitors or inducers within 2 weeks

NCT07499674

A Phase 3, Multi-center, Randomized, Open Label Study to Evaluate the Safety and Efficacy of Abenacianine (VGT-309), a Tumor-Targeted, Activatable Fluorescent Imaging Agent, to Identify Cancer in Subjects Undergoing Surgery for Cancer in the Lung - VISUALIZE 2

Organization/Sponsor: Vergent Bioscience, Inc.


Example patient: A 62-year-old man with a newly identified lung mass scheduled for surgical resection who has not received any cancer treatment in the past four weeks and has no allergies to contrast agents.

Phase 3

Interventions

  • Imaging Agent: Abenacianine
    Summary: Abenacianine is an investigational tumor-targeted, activatable fluorescent imaging agent that illuminates malignant tissue during lung cancer surgery to aid in visualization and identification of cancer; has FDA fast track designation (Summary of Web Search).
  • Imaging Modality: Near Infrared (NIR) Imaging
    Summary: Medical imaging using infrared wavelengths for direct visualization of tissue vasculature, assessing oxygenation, and use with fluorescent dyes for targeted imaging applications (NCI Thesaurus).

Key Inclusion

  • At least 18 years of age
  • Scheduled for or planning surgical resection of lung lesion or mass with diagnostic and/or curative intent
  • Meet all requirements for planned surgery per surgeon and anesthesiologist
  • Willing and able to sign informed consent and comply with study procedures
  • Female participants must use highly effective contraception or be of non-childbearing potential
  • Male participants must use highly effective contraception if engaging with female partner of childbearing potential
  • No participation in interventional clinical trial within last 30 days

Key Exclusion

  • Known allergy or reaction to radiographic contrast agents, ICG, or any component of abenacianine
  • Received chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to enrollment
  • Co-morbidity or habit that interferes with ability to comply with and complete study
  • Not a candidate for standard of care surgery per surgeon or anesthesiologist
  • Prisoners, institutionalized individuals, or unable to consent for themselves

NCT07540572

An Open Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of IDE574 as Monotherapy in Locally Advanced or Metastatic Solid Tumors and as Combination Therapy With Fulvestrant in Locally Advanced or Metastatic ER+, HER2- Breast Cancer

Organization/Sponsor: IDEAYA Biosciences


Example patient: A 58-year-old postmenopausal woman with metastatic ER-positive, HER2-negative breast cancer who progressed after treatment with letrozole and palbociclib, with ECOG performance status 1 and adequate organ function.

Phase 1

Interventions

  • Drug: IDE574
    Summary: IDE574 is a dual inhibitor of KAT6/7 enzymes that blocks specific histone acetyltransferases to inhibit cancer growth in breast cancer and other solid tumors, currently in Phase 1 trials (Web Search).
  • Drug: Fulvestrant injection
    Summary: Fulvestrant is an estrogen receptor antagonist that degrades estrogen receptors to block estrogen signaling in hormone receptor-positive, HER2-negative advanced breast cancer, administered intramuscularly (FDA label).

Key Inclusion

  • Advanced or metastatic ER+, HER2- breast cancer, NSCLC, CRPC, or MSS colorectal adenocarcinoma
  • Progressed on/after at least one line of standard therapy or intolerant to additional effective therapies
  • ER+, HER2- breast cancer progressed after at least 1 prior endocrine therapy and CDK4/6 inhibitor
  • ECOG performance status ≤1
  • Adequate bone marrow, renal and liver function
  • Life expectancy >3 months
  • Archival tissue sample available for testing
  • Female participants of childbearing potential willing to undergo medically induced menopause (Parts 2A and 2B)

Key Exclusion

  • Known symptomatic brain metastases or leptomeningeal metastasis
  • Known primary CNS malignancy or other malignancies within 2 years
  • Impairment of GI function or GI disease that may alter IDE574 absorption
  • Active liver or biliary disease
  • Active, uncontrolled bacterial, fungal, or viral infection
  • Clinically significant cardiac abnormalities or blood clotting events within 6 months
  • Prior irradiation to >25% of bone marrow
  • Known or suspected hypersensitivity to IDE574, fulvestrant, or their excipients

NCT07458425

Systemwide Early Notification Tool for ImmineNt Lung Cancer-1 Study: Evaluating Patient-Reported Outcomes of Artificial Intelligence Inferred Lung Cancer Risk

Organization/Sponsor: University of Illinois at Chicago


Example patient: A 62-year-old current smoker with 30 pack-year history registered at UI Health, no prior cancer history, eligible for LDCT screening per USPSTF guidelines.

Phase N/A

Interventions

  • Diagnostic Tool: Research-use-only multimodal AI risk model
    Summary: Predicts lung cancer outcomes using electronic health records and pathology data via deep learning for risk stratification, biomarker identification, and personalized treatment planning (Web Search).
  • Diagnostic Tool: Artificial Intelligence (AI) test
    Summary: Analyzes chest X-rays for early lung cancer detection, prioritizes cases, identifies nodules missed by radiologists, and assists in clinical trial matching (Web Search).

Key Inclusion

  • Age 50-80 years
  • Eligible for LDCT screening per USPSTF criteria
  • 20 pack-year smoking history
  • Currently smoke or quit within past 15 years
  • Registered patients at UI Health or Mile Square FQHC
  • Able to provide written informed consent
  • Women of childbearing potential must have negative pregnancy test
  • Ability to comply with study procedures

Key Exclusion

  • Quit smoking 15 or more years ago
  • Undergoing diagnostic evaluation for suspected cancer
  • Personal history of invasive cancer within 5 years
  • Cancer diagnosed over 5 years ago and never treated
  • Definitive cancer treatment within 5 years
  • Unable to comply with protocol procedures
  • Not currently registered at UIH
  • Currently pregnant