Clinical Trials for Non-Small Cell Lung Cancer

A Phase III, Open-label, Sponsor-blind, Randomized Study of Dato-DXd With or Without Osimertinib Versus Platinum-based Doublet Chemotherapy for Participants With EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer Whose Disease Has Progressed on Prior Osimertinib Treatment (TROPION-Lung15)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: Eligible patients are adults with advanced or metastatic non-squamous EGFR-mutated NSCLC who have progressed after prior osimertinib; the trial compares Dato-DXd (a TROP2-targeted antibody-drug conjugate) alone or with osimertinib versus standard platinum-based doublet chemotherapy. Patients with uncontrolled comorbidities or active/untreated CNS metastases are excluded.

ClinicalTrials.gov ID: NCT06417814

SUNRAY-01, A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum Regardless of PD-L1 Expression

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: This trial enrolls adults with previously untreated, unresectable stage IIIB-IV KRAS G12C-mutant NSCLC (ECOG 0-1, no other actionable mutations), randomizing them to receive the investigational KRAS G12C inhibitor olomorasib (LY3537982, a selective covalent inhibitor of GDP-bound KRAS G12C) plus pembrolizumab—with or without chemotherapy—versus standard first-line regimens based on PD-L1 status and tumor histology. Patients with active CNS metastases or prior systemic therapy for advanced disease are excluded.

ClinicalTrials.gov ID: NCT06119581

A Phase III, Open-label, Randomised Study of Osimertinib With or Without Datopotamab Deruxtecan (Dato-DXd), as First-line Treatment in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation-positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: This trial enrolls treatment-naïve adults with stage IIIB/IIIC or IV nonsquamous NSCLC harboring EGFR Ex19del or L858R mutations, randomizing them to receive either standard osimertinib or osimertinib combined with datopotamab deruxtecan, a TROP2-directed antibody-drug conjugate. Key exclusions include prior EGFR TKI or TROP2 therapy and significant interstitial lung or cardiac disease.

ClinicalTrials.gov ID: NCT06350097

A Randomized Phase 3 Study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in Subjects With No Prior Therapy for Advanced or Metastatic PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung07)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: Eligible patients are adults with previously untreated, advanced or metastatic non-squamous NSCLC, PD-L1 TPS &lt;50%, and no actionable genomic alterations. The trial compares pembrolizumab plus platinum/pemetrexed versus combinations including datopotamab deruxtecan (a TROP2-directed antibody-drug conjugate) with pembrolizumab, with or without platinum chemotherapy.

ClinicalTrials.gov ID: NCT05555732

KEYMAKER-U01 Substudy 01G: A Phase 2, Umbrella Study With Rolling Arms of Investigational Agents in Combination With Pembrolizumab With or Without Platinum-based Chemotherapy in Treatment-Naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: This trial enrolls adults with treatment-naïve stage IV squamous or non-squamous NSCLC (ECOG 0-1, no actionable EGFR/ALK/ROS1 mutations for squamous histology) and compares standard pembrolizumab plus platinum-based chemotherapy to pembrolizumab combined with HER3-DXd, an antibody-drug conjugate targeting HER3 (ERBB3) with a topoisomerase I inhibitor payload.

ClinicalTrials.gov ID: NCT06731907

A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 Antibody), Cemiplimab (Anti-PD-1 Antibody), and Chemotherapy Versus Cemiplimab and Chemotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Irrespective of PD-L1 Expression Levels

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: This trial enrolls adults with previously untreated, advanced non-squamous or squamous NSCLC without EGFR/ALK/ROS1 alterations, randomizing them to receive standard platinum-doublet chemotherapy plus cemiplimab (anti-PD-1), with or without the addition of investigational fianlimab (an anti-LAG-3 immune checkpoint inhibitor). Eligible patients must have measurable disease, ECOG 0-1, and no active brain metastases or significant autoimmune disease.

ClinicalTrials.gov ID: NCT05800015

Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers That Progressed on PD-1/PD-L1 Inhibitors

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: This trial enrolls adults with metastatic squamous NSCLC, ECOG 0-1, who have progressed after at least 12 weeks of PD-1/PD-L1 inhibitor and platinum-based chemotherapy, randomizing them to docetaxel or gotistobart (ONC-392), a next-generation anti-CTLA-4 antibody designed to selectively deplete intratumoral regulatory T cells while sparing peripheral Tregs. Key exclusions include actionable oncogenic drivers (except KRAS), symptomatic brain metastases, and significant comorbidities.

ClinicalTrials.gov ID: NCT05671510

A Randomized, Phase 3, Open-label Study to Evaluate Sigvotatug Vedotin Compared With Docetaxel in Adult Participants With Previously Treated Non-small Cell Lung Cancer (Be6A Lung-01)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: This trial enrolls adults with unresectable locally advanced or metastatic nonsquamous NSCLC who have progressed after platinum-based chemotherapy and anti-PD-(L)1 therapy, comparing sigvotatug vedotin—an antibody-drug conjugate targeting integrin beta-6 and delivering MMAE—to standard docetaxel chemotherapy. Patients must have measurable disease, ECOG 0-1, and no prior antimicrotubule agents in the advanced/metastatic setting.

ClinicalTrials.gov ID: NCT06012435

AN OPEN-LABEL, RANDOMIZED, CONTROLLED PHASE 3 STUDY OF SIGVOTATUG VEDOTIN IN COMBINATION WITH PEMBROLIZUMAB COMPARED WITH PEMBROLIZUMAB MONOTHERAPY AS FIRST-LINE TREATMENT IN PARTICIPANTS WITH PD-L1 HIGH (≥50% OF TUMOR CELLS EXPRESSING PD-L1), LOCALLY ADVANCED, UNRESECTABLE, OR METASTATIC NON-SMALL CELL LUNG CANCER (BE6A LUNG-02)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: This trial enrolls adults with previously untreated, locally advanced or metastatic NSCLC and high PD-L1 expression (≥50%), excluding those with common targetable mutations or prior checkpoint inhibitor therapy, to compare pembrolizumab alone versus pembrolizumab plus sigvotatug vedotin, an integrin beta-6–targeting antibody-drug conjugate.

ClinicalTrials.gov ID: NCT06758401

A Randomized, Multicenter, Double-blind, Phase 3 Study to Investigate the Safety and Efficacy of Belrestotug in Combination With Dostarlimab Compared With Placebo in Combination With Pembrolizumab in Participants With Previously Untreated, Unresectable, Locally Advanced or Metastatic PD-L1 Selected Non-small Cell Lung Cancer (GALAXIES Lung-301)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: This trial enrolls adults with previously untreated, unresectable, locally advanced or metastatic non-small cell lung cancer with high PD-L1 expression (≥50%), without actionable mutations, and compares the PD-1 inhibitor dostarlimab plus belrestotug (an investigational anti-TIGIT antibody) versus standard pembrolizumab monotherapy. Key exclusions include never-smokers and patients with EGFR/ALK alterations, prior checkpoint inhibitor exposure, or active brain metastases.

ClinicalTrials.gov ID: NCT06472076