Clinical Trials for Non-Small Cell Lung Cancer

A Phase 3 Open-label, Randomized, Active-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Orally Administered BAY 2927088 Compared With Standard of Care as a First-line Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With HER2-activating Mutations

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.

TrialFetch AI summary: Eligible patients are adults with locally advanced or metastatic, non-squamous NSCLC harboring activating HER2 mutations in the tyrosine kinase domain, who are treatment-naïve for advanced disease. Patients will be randomized to receive either BAY 2927088, an oral reversible inhibitor targeting mutant HER2 and EGFR, or standard of care with pembrolizumab plus platinum-pemetrexed chemotherapy.

ClinicalTrials.gov ID: NCT06452277

Randomized, Controlled, Open-label, Phase 3, Global Multi - Center Trial to Assess the Efficacy and Safety of Zipalertinib Plus Chemotherapy Versus Chemotherapy Alone, in Patients With Previously Untreated, Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations

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.

TrialFetch AI summary: This trial enrolls adults with previously untreated, locally advanced or metastatic nonsquamous NSCLC harboring EGFR exon 20 insertion mutations (including those with stable, treated brain metastases), comparing standard first-line platinum-based chemotherapy plus zipalertinib—a selective, irreversible EGFR exon 20ins tyrosine kinase inhibitor—versus chemotherapy alone.

ClinicalTrials.gov ID: NCT05973773

A Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater Than or Equal to 50% (TroFuse-007)

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.

TrialFetch AI summary: This trial enrolls adults with previously untreated metastatic NSCLC (non-squamous or squamous) and high PD-L1 expression (TPS ≥50%) without EGFR, ALK, or ROS1 alterations, comparing pembrolizumab monotherapy to pembrolizumab plus sacituzumab tirumotecan, a TROP2-directed antibody-drug conjugate linked to a topoisomerase I inhibitor.

ClinicalTrials.gov ID: NCT06170788

Beamion LUNG 2: A Phase III, Open-label, Randomized, Active-controlled, Multi-centre Trial Evaluating Orally Administered Zongertinib (BI 1810631) Compared With Standard of Care as First-line Treatment in Patients With Unresectable, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Harbouring HER2 Tyrosine Kinase Domain Mutations

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.

TrialFetch AI summary: This trial enrolls adults with unresectable, locally advanced or metastatic non-squamous NSCLC harboring HER2 kinase domain mutations, randomizing them to first-line treatment with either zongertinib, an oral selective inhibitor of HER2, or standard of care with pembrolizumab plus platinum-pemetrexed chemotherapy. Eligible patients must be previously untreated for advanced disease and have at least one measurable lesion.

ClinicalTrials.gov ID: NCT06151574

A Phase 2 Trial of SX-682 and Pembrolizumab in Patients With Treatment Naive Stage IV or Recurrent 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.

TrialFetch AI summary: Eligible patients are adults with treatment-naive, stage IIIC or IV NSCLC (PD-L1 ≥1%, no EGFR/ALK/ROS1/RET alterations, ECOG 0-1), who will receive a combination of pembrolizumab and SX-682, an oral CXCR1/2 inhibitor designed to block myeloid-derived suppressor cell infiltration and enhance anti-tumor immunity.

ClinicalTrials.gov ID: NCT05570825

A Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-line Treatment of Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High 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.

TrialFetch AI summary: This trial enrolls adults with treatment-naïve, metastatic squamous or non-squamous NSCLC and high PD-L1 expression (TPS >50%, no driver mutations), randomizing them to receive either pembrolizumab or ivonescimab, a bispecific antibody targeting both PD-1 and VEGF. Patients with actionable mutations or symptomatic CNS metastases are excluded.

ClinicalTrials.gov ID: NCT06767514

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.

TrialFetch 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.

TrialFetch 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

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.

TrialFetch 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

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.

TrialFetch 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