Clinical Trials for Non-Small Cell Lung Cancer

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.

TrialFetch 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.

TrialFetch 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 Phase III, Randomised, Open-Label, Multicentre Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung17)

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 stage IIIB/IIIC–IV TROP2 (NMR)-positive non-squamous NSCLC without actionable genomic alterations (EGFR/ALK/ROS1 negative and no other actionable drivers), ECOG 0–1, with RECIST-measurable progression after platinum chemotherapy and anti–PD-1/PD-L1 therapy. Randomized to datopotamab deruxtecan (TROP2-directed antibody–drug conjugate delivering a topoisomerase I inhibitor payload) IV q3w versus docetaxel IV q3w.

ClinicalTrials.gov ID: NCT07291037

Ph 2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab and Nivolumab With or Without Docetaxel Versus Docetaxel in 2L Treatment of Participants With Metastatic NSCLC (GDFATHER-NSCLC-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.

TrialFetch AI summary: Adults with metastatic stage IV non-squamous NSCLC without actionable drivers, ECOG 0–1, measurable disease, who progressed on exactly one first-line regimen containing anti–PD-(L)1 therapy while still receiving it (checkpoint-inhibitor–refractory) in the 2L setting. Randomized, blinded Q3W IV comparison of visugromab (anti–GDF-15 mAb intended to reverse PD-1 resistance by restoring T-cell trafficking) + nivolumab with or without docetaxel versus docetaxel alone (with placebo controls).

ClinicalTrials.gov ID: NCT07246863

Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan Compared to Standard of Care in Subjects With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer After Progression on a Third-Generation EGFR TKI

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 non-squamous NSCLC harboring EGFR exon 19 del or L858R (ECOG 0–1) with measurable disease and radiographic progression after exactly one prior third-generation EGFR TKI (including adjuvant; stable/asymptomatic treated CNS mets allowed) are randomized to telisotuzumab adizutecan (ABBV-400), a c-Met–targeting ADC delivering a cleavable-linker topoisomerase I inhibitor payload, versus investigator’s choice standard-of-care therapy. The study includes two telisotuzumab adizutecan dose levels initially to select the RP3D, then compares RP3D against standard care.

ClinicalTrials.gov ID: NCT07155187

Phase 1 / 2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects With Non-Small Cell Lung Cancer With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors

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.

TrialFetch AI summary: The trial investigates APL-101, a selective c-MET receptor tyrosine kinase inhibitor, in adult patients with NSCLC exhibiting c-Met exon 14 skipping mutations, various solid tumors with MET alterations, and primary CNS tumors. It includes APL-101 monotherapy and combination therapy with EGFR inhibitors in cases of acquired MET amplification resistance.

ClinicalTrials.gov ID: NCT03175224

A Phase 2 Study Evaluating the Efficacy of Anti-CD38 Antibody in Combination With KRAS Vaccine and Anti-PD-1 Antibody in Subjects With Pancreatic Ductal Adenocarcinoma and Refractory 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

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: This trial involves patients with advanced non-small cell lung cancer (NSCLC) who have progressed on frontline anti-PD-1/PD-L1 therapies and pancreatic ductal adenocarcinoma (PDAC) patients who have failed one prior treatment, focusing on those with specific KRAS mutations. Participants receive treatments combining daratumumab (anti-CD38 monoclonal antibody), nivolumab (anti-PD-1 antibody), and a KRAS vaccine.

ClinicalTrials.gov ID: NCT06015724

A Phase II, Multisite, Open-label, Single Arm Trial of BNT327 in Combination With Docetaxel in Second-line Stage IV Non-small Cell Lung Cancer (NSCLC) Following Chemoimmunotherapy

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

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: This trial targets patients with Stage IV NSCLC who have progressed after first-line chemoimmunotherapy and explores the combination of BNT327, a bispecific antibody targeting PD-L1 and VEGF-A, with docetaxel.

ClinicalTrials.gov ID: NCT06841055

A Phase III, Randomised, Open-Label Study of Savolitinib in Combination With Osimertinib Versus Platinum-Based Doublet Chemotherapy in Participants With EGFR Mutated, MET-Overexpressed and/or Amplified, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed on Treatment With Osimertinib (SAFFRON).

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.

TrialFetch AI summary: This trial enrolls adults with locally advanced or metastatic EGFR-mutated NSCLC (exon 19 deletion, L858R, and/or T790M) and MET overexpression/amplification who have progressed on osimertinib, randomizing them to savolitinib (a selective MET inhibitor) plus osimertinib versus platinum-based doublet chemotherapy with pemetrexed. Eligible patients must have ECOG 0-1 and no prior MET inhibitor use or uncontrolled comorbidities.

ClinicalTrials.gov ID: NCT05261399

A Phase 2 Study of Defactinib and Avutometinib, in Combination With Nivolumab for Patients With Anti-PD1 Refractory LKB1-Mutant Advanced Lung Adenocarcinoma

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

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: This trial is enrolling adults with advanced, LKB1-mutant, anti-PD1-refractory lung adenocarcinoma (including KRAS-mutant subset), testing the combination of oral defactinib (FAK/Pyk2 inhibitor), oral avutometinib (dual RAF/MEK inhibitor), and intravenous nivolumab. Eligible patients must have progressed on prior anti-PD1 therapy and first line chemotherapy, and have ECOG 0-1.

ClinicalTrials.gov ID: NCT06495125