Clinical Trials for Non-Small Cell Lung Cancer

A Randomised, Open-label, Phase 3 Trial Comparing the Efficacy and Safety of OSE2101 Versus Docetaxel in HLA-A2 Positive Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) With Secondary Resistance to Immune Checkpoint Inhibitor

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 HLA-A2 positive patients with metastatic squamous or non-squamous NSCLC who have developed secondary resistance to immune checkpoint inhibitors and are ineligible for targeted therapies, randomizing them to receive either OSE2101, a neoepitope-based cancer vaccine designed to stimulate tumor-specific cytotoxic T-cell responses, or standard docetaxel chemotherapy.

ClinicalTrials.gov ID: NCT06472245

A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 193 in Subjects With Methylthioadenosine Phosphorylase (MTAP)-Deleted Previously Treated Advanced 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 previously treated, advanced or metastatic NSCLC harboring homozygous MTAP deletion (and no actionable driver mutations), evaluating the oral PRMT5 inhibitor AMG 193, which targets MTAP-deleted tumors via synthetic lethality. AMG 193 is given as monotherapy in continuous 28-day cycles.

ClinicalTrials.gov ID: NCT06593522

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.

TrialFetch 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

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

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

KEYMAKER-U01 Substudy 01H: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous 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 stage IV nonsquamous NSCLC who have progressed after both anti-PD-(L)1 therapy and platinum-based chemotherapy, randomizing them to receive either raludotatug deruxtecan (a CDH6-targeting antibody-drug conjugate), ifinatamab deruxtecan (a B7-H3-targeting antibody-drug conjugate), or standard docetaxel. Patients with EGFR, ALK, or ROS1 alterations eligible for targeted therapy are excluded.

ClinicalTrials.gov ID: NCT06780085

A Multicenter, Randomized, Open-label, Phase 2 Study Evaluating the Safety and Efficacy of BMS-986504 Monotherapy in Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion After Progression on Prior Therapies

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 advanced or metastatic NSCLC harboring homozygous MTAP deletion and disease progression after prior systemic therapies; the trial randomizes participants to two oral dosing regimens of BMS-986504, a selective PRMT5 inhibitor that targets MTAP-deleted tumors through synthetic lethality.

ClinicalTrials.gov ID: NCT06855771

A Ph2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab Versus Placebo, in Combination With Pembrolizumab, Pemetrexed, and Carboplatin, in 1L Treatment of Participants With Metastatic NSCLC (GDFATHER-NSCLC-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.

TrialFetch AI summary: Adults with newly diagnosed metastatic non-squamous NSCLC (ECOG 0–1) lacking actionable driver mutations receive pembrolizumab+pemetrexed+carboplatin with either visugromab or placebo; PD-L1 ≥50% allowed only when CPI monotherapy isn’t appropriate. Visugromab is a humanized anti–GDF-15 monoclonal antibody intended to enhance T-cell trafficking and overcome PD-(L)1 resistance.

ClinicalTrials.gov ID: NCT07098988

A Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With First-Line Osimertinib Treatment and Harbor a C797S Mutation

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: Adults with locally advanced/metastatic EGFR-mutant NSCLC who progressed on first-line osimertinib via acquired EGFR C797S (including patients with stable brain mets) receive oral WSD0922-FU BID. WSD0922-FU is a brain-penetrant, reversible, non-ATP-competitive EGFR inhibitor designed to target sensitizing EGFR mutations and EGFRm/C797S with relative selectivity over wild-type EGFR.

ClinicalTrials.gov ID: NCT06868485

A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-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: Adults with treatment‑naive, advanced/metastatic nonsquamous NSCLC harboring KRAS G12C are randomized to MK‑1084 (a selective covalent KRAS G12C inhibitor) plus subcutaneous pembrolizumab with berahyaluronidase alfa versus subcutaneous pembrolizumab with berahyaluronidase alfa plus pemetrexed and platinum chemotherapy. Primary analysis focuses on PFS (BICR) in PD‑L1 TPS ≥1%, with key secondary endpoints including PFS/OS in all-comers and response outcomes.

ClinicalTrials.gov ID: NCT07190248