Clinical Trials for Non-Small Cell Lung Cancer

KEYMAKER-U01 Substudy 01I: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Squamous 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 stage IV squamous NSCLC whose disease has progressed after both anti-PD-(L)1 immunotherapy and platinum chemotherapy, randomizing them to either standard docetaxel or investigational antibody-drug conjugates: Raludotatug deruxtecan (targeting CDH6) or Infinatamab deruxtecan (targeting B7-H3).

ClinicalTrials.gov ID: NCT06780098

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.

HealthScout 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.

HealthScout 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.

HealthScout 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.

HealthScout 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

A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Patients With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous 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: Untreated adults with advanced/metastatic non-squamous NSCLC harboring KRAS G12C (ECOG 0–1) are randomized to divarasib (selective, irreversible KRAS G12C inhibitor) plus pembrolizumab versus standard pembrolizumab plus platinum/pemetrexed. Excludes other actionable drivers, prior KRAS/IO therapy, and active CNS disease; endpoints include PFS and OS.

ClinicalTrials.gov ID: NCT06793215

A RANDOMIZED, PHASE 3, OPEN-LABEL STUDY TO EVALUATE PF-08046054/SGN-PDLlV VERSUS DOCETAXEL IN ADULT PARTICIPANTS WITH PREVIOUSLY-TREATED PROGRAMMED CELL DEATH LIGAND 1 (PD-Ll) POSITIVE 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: Adults with PD-L1–positive (≥1%) unresectable stage IIIB/IIIC or metastatic NSCLC who have progressed after PD-(L)1 therapy and platinum chemotherapy (and after appropriate targeted therapy for actionable alterations) are randomized to PF-08046054 (SGN-PDL1V), a PD-L1–targeted antibody–drug conjugate delivering the microtubule toxin MMAE, versus docetaxel. Excludes neuroendocrine histology, active CNS disease requiring >10 mg prednisone equivalent, leptomeningeal disease, prior MMAE agents, or prior docetaxel.

ClinicalTrials.gov ID: NCT07144280

A Study of Open-label Orally Administered JBI-802 Alone or in Combination With Pembrolizumab in Patients With Advanced NSCLC Tumors Harboring an STK11 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.

HealthScout AI summary: Adults with advanced/metastatic NSCLC harboring an STK11 mutation (ECOG 0–2) receive oral JBI-802, a first-in-class dual LSD1/HDAC6 inhibitor targeting the CoREST complex, either as monotherapy or combined with pembrolizumab. Key exclusions include unstable CNS disease, significant cardiac comorbidities, active infections, QTcF >480 ms, recent therapy, and strong CYP3A/CYP2D6 modulators.

ClinicalTrials.gov ID: NCT07207395

A Randomized Phase 2/3 Study of BMS-986504 in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion

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: Adults with metastatic NSCLC (ECOG 0–1) harboring homozygous MTAP deletion/MTAP loss are randomized to pembrolizumab plus platinum-doublet chemotherapy with or without BMS-986504, an oral selective MTA-cooperative PRMT5 inhibitor exploiting MTAP-deletion synthetic lethality. Nonsquamous patients with targetable first-line drivers are excluded; standard pemetrexed- or taxane-based platinum regimens are used by histology.

ClinicalTrials.gov ID: NCT07063745

A Multi-center Phase II Study of Ipatasertib in Combination With Docetaxel in Metastatic/Advanced NSCLC Patients Who Have Failed or Are Intolerant to 1st Line Immunotherapy (Ipat-Lung)

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.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: This trial involves adult patients with advanced or metastatic NSCLC who have not responded to or cannot tolerate first-line anti-PD1/PD-L1 therapies and lack targetable mutations, testing the efficacy of the pan-AKT inhibitor ipatasertib in combination with docetaxel.

ClinicalTrials.gov ID: NCT04467801