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

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

TACTI-004, a Double-Blinded, Randomized Phase 3 Trial in Patients With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Receiving Eftilagimod Alfa (MHC Class II Agonist) in Combination With Pembrolizumab (PD-1 Antagonist) and Chemotherapy.

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 IIIB/C or IV NSCLC not amenable to curative therapy (ECOG 0–1; PD-L1 unselected; excluding EGFR-sensitizing mutations, ALK fusions, or ROS1 translocations; treated/stable brain metastases allowed) are randomized to add eftilagimod alfa (soluble LAG-3–Ig fusion protein, MHC class II agonist that activates antigen-presenting cells to enhance T-cell priming) or placebo to standard first-line pembrolizumab plus histology-appropriate platinum-doublet chemotherapy. Primary outcomes are overall survival and RECIST 1.1 progression-free survival.

ClinicalTrials.gov ID: NCT06726265

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