Clinical Trials for Non-Small Cell Lung Cancer

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 or metastatic nonsquamous NSCLC harboring an EGFR exon 19 deletion or L858R mutation and progressing after one third-generation EGFR TKI receive telisotuzumab adizutecan or investigator-chosen standard of care. Telisotuzumab adizutecan is a c-Met–targeting antibody–drug conjugate that delivers a topoisomerase I inhibitor.

ClinicalTrials.gov ID: NCT07155187

A Phase 2, Open-label, Multicohort Study of Rinatabart Sesutecan (Rina-S) in Participants With 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: Patients with progressive, unresectable locally advanced or metastatic lung adenocarcinoma and ECOG performance status 0–1 receive rinatabart sesutecan monotherapy. This investigational folate receptor alpha–targeted antibody–drug conjugate delivers exatecan, a topoisomerase I inhibitor.

ClinicalTrials.gov ID: NCT07288177

AN INTERVENTIONAL PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS PEMBROLIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN ADULT PARTICIPANTS WITH 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: Adults with previously untreated, unresectable stage IIIB/IIIC or metastatic squamous or nonsquamous NSCLC, ECOG 0–1, and no actionable alteration with an available first-line therapy receive histology-specific chemotherapy plus either PF-08634404 or pembrolizumab. PF-08634404 is an investigational bispecific antibody targeting PD-1 and VEGF; treatment continues as maintenance with the assigned antibody alone for squamous disease or with chemotherapy for nonsquamous disease.

ClinicalTrials.gov ID: NCT07222566

A Randomized, Open-Label, Multicenter, Phase 3 Study Evaluating the Efficacy and Safety of IBI363 Versus Docetaxel in Participants With Unresectable Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer With Disease Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy

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 unresectable locally advanced or metastatic squamous NSCLC that has progressed after platinum chemotherapy and PD-1/PD-L1 immunotherapy are randomized to IBI363 or docetaxel. IBI363 is an investigational PD-1 antibody fused to an IL-2 mutein, designed to combine checkpoint blockade with targeted IL-2 signaling.

ClinicalTrials.gov ID: NCT07217301

A Phase II Trial of Telisotuzumab Vedotin With Osimertinib for EGFR Mutated NSCLC With c-MET Overexpression That is Progressing on Osimertinib

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 incurable EGFR-mutated NSCLC and intermediate or high c-MET expression after progression on an osimertinib-containing regimen receive continued osimertinib plus telisotuzumab vedotin. Telisotuzumab vedotin is a c-MET–directed antibody–drug conjugate that delivers the microtubule inhibitor MMAE to c-MET–expressing cells.

ClinicalTrials.gov ID: NCT07323641

ROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With PD-L1 ≥ 50%.

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: For patients with previously untreated stage IIIB/IIIC or IV NSCLC, PD-L1 expression ≥50%, and ECOG performance status 0–1, this study compares first-line pumitamig monotherapy with pembrolizumab. Pumitamig is an investigational bispecific antibody targeting PD-L1 and VEGF-A; patients with actionable alterations warranting approved first-line therapy are excluded.

ClinicalTrials.gov ID: NCT07361510

A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer (TeLuRide-008).

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 previously untreated stage IV squamous or nonsquamous NSCLC, ECOG 0–1, and no actionable alteration with an approved first-line targeted therapy receive pembrolizumab and histology-appropriate platinum-based chemotherapy plus either EIK1001 or placebo. EIK1001 is an investigational TLR7/8 agonist intended to stimulate innate immune signaling and antigen presentation.

ClinicalTrials.gov ID: NCT07365319

A Randomized, Double-blind, Phase 3 Study of Pembrolizumab + Pemetrexed + Platinum Chemotherapy With or Without Zoldonrasib (RMC-9805) as First Line Treatment in Patients With Metastatic Non-squamous RAS G12D-Mutated Non-small Cell Lung Cancer (RASolve 308)

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 previously untreated metastatic nonsquamous NSCLC harboring a RAS G12D mutation receive first-line pembrolizumab, pemetrexed, and cisplatin or carboplatin plus either zoldonrasib or placebo. Zoldonrasib is an investigational inhibitor of active KRAS G12D that suppresses downstream RAS signaling.

ClinicalTrials.gov ID: NCT07777822

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: Adults with unresectable or metastatic NSCLC or other solid tumors with MET alterations or dysregulation, including selected primary CNS tumors, receive oral vebreltinib, a selective MET tyrosine-kinase inhibitor. Patients with EGFR-mutant NSCLC and acquired MET amplification after initial benefit from first-line EGFR inhibition receive vebreltinib added to their EGFR inhibitor.

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: Adults with advanced PDAC after one prior treatment or NSCLC progressing after first-line anti-PD-1/PD-L1 therapy are eligible if their tumors harbor specified KRAS codon 12 or 13 mutations. Both cohorts receive TG-01, a mutant KRAS peptide vaccine with QS-21 adjuvant, plus the anti-CD38 antibody daratumumab and the anti-PD-1 antibody nivolumab.

ClinicalTrials.gov ID: NCT06015724