Clinical Trials for Non-Small Cell Lung Cancer

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

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: Adults with locally advanced or metastatic non-squamous NSCLC (adenocarcinoma only), ECOG 0–1, measurable disease, and radiographic progression after their most recent therapy (with or without actionable genomic alterations; stable treated brain metastases allowed). Single-arm treatment is rinatabart sesutecan monotherapy q3 weeks, an FRα-targeting antibody–drug conjugate delivering a topoisomerase I inhibitor payload, continued until progression or unacceptable toxicity.

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 unresectable stage IIIB/IIIC or metastatic stage IV squamous or non-squamous NSCLC without actionable driver alterations, systemic-therapy naïve for advanced disease (ECOG 0–1, measurable disease, known PD-L1 status), are randomized to PF-08634404/SSGJ-707 (investigational bispecific antibody targeting PD-1 and VEGF) plus histology-appropriate platinum-based chemotherapy followed by maintenance, versus pembrolizumab plus the same chemotherapy followed by standard maintenance. Primary outcomes compare overall survival and centrally reviewed PFS between regimens.

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 (ECOG 0–1, RECIST-measurable) whose disease progressed during or within 6 months after prior anti–PD-1/PD-L1 therapy and after platinum-doublet chemotherapy are randomized 1:1 to IBI363 vs docetaxel. IBI363 is a PD-1–blocking bispecific fusion protein delivering a CD25-biased IL-2 mutein to stimulate tumor-reactive T/NK cells, given IV Q3W after a priming dose, compared with standard docetaxel 75 mg/m² IV Q3W.

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: Single-arm study for adults with incurable EGFR-mutated, predominantly adenocarcinoma NSCLC with c-MET overexpression after progression on osimertinib, ECOG 0–1, measurable disease, and no active/symptomatic CNS disease or significant ILD/pneumonitis. Patients continue osimertinib 80 mg daily with telisotuzumab vedotin, a c-MET–directed antibody-drug conjugate delivering the microtubule inhibitor MMAE.

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: Randomized first-line study for adults with unresectable stage IIIB/IIIC or stage IV squamous or nonsquamous NSCLC, PD-L1 ≥50%, ECOG 0–1, measurable disease, and no actionable driver alterations or prior systemic therapy for advanced disease. Participants receive pumitamig/BNT327, an investigational bispecific antibody targeting PD-L1 and VEGF-A, versus standard pembrolizumab monotherapy.

ClinicalTrials.gov ID: NCT07361510

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

Phase II Trial of LP-300 in Combination with Carboplatin and Pemetrexed in Never Smoker Patients with Relapsed Advanced Primary Adenocarcinoma of the Lung After Treatment with Tyrosine Kinase Inhibitors (The HARMONIC Study)

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 is for never smoker patients with relapsed advanced primary adenocarcinoma of the lung, featuring actionable genomic alterations, who have progressed after tyrosine kinase inhibitor therapies. It examines the combination of the investigational multi-tyrosine kinase receptor inhibitor LP-300 with carboplatin and pemetrexed, compared to the standard carboplatin-pemetrexed regimen.

ClinicalTrials.gov ID: NCT05456256