Clinical Trials for Non-Small Cell Lung Cancer

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.

HealthScout 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.

HealthScout 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 Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of Taletrectinib in Patients with Advanced or Metastatic ROS1 Positive NSCLC and Other 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.

HealthScout AI summary: This trial focuses on advanced or metastatic ROS1-positive NSCLC and other solid tumor patients receiving taletrectinib, a ROS1 and NTRK tyrosine kinase inhibitor, either as monotherapy or combined with carboplatin and pemetrexed, targeting both treatment-naïve and TKI-experienced individuals.

ClinicalTrials.gov ID: NCT04919811

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.

HealthScout 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.

HealthScout 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.

HealthScout 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

A Phase II Open-label Multi-cohort Study Evaluating the Efficacy of Tiragolumab With Atezolizumab Plus Bevacizumab in Previously-Treated Advanced Non-squamous 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.

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 enrolls adults with advanced non-squamous NSCLC who have progressed after anti-PD(L)1 therapy or, for EGFR-mutant patients, after EGFR-targeted therapy, to receive tiragolumab (a TIGIT inhibitor), atezolizumab, and bevacizumab. Key eligibility includes ECOG 0-2, no known driver mutations (except EGFR-mutant cohort), and no untreated/symptomatic CNS metastases.

ClinicalTrials.gov ID: NCT04958811

A Multicenter, Open-label, Phase IIb Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Non-resistant Uncommon EGFR Mutations Only, Including L861Q, G719X, and/or S768I)

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 enrolls adults with locally advanced or metastatic NSCLC harboring non-resistant, uncommon EGFR mutations (L861Q, G719X, and/or S768I) who have had ≤1 prior chemotherapy and no prior EGFR-TKI therapy, and treats them with Sutetinib Maleate, an investigational irreversible EGFR tyrosine kinase inhibitor targeting these mutations.

ClinicalTrials.gov ID: NCT05168566

A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects With Advanced or Metastatic PD-L1 High (TPS ≥50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung08)

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 enrolls adults with previously untreated advanced or metastatic non-squamous NSCLC, high PD-L1 expression (TPS ≥50%), and no EGFR, ALK, or ROS1 alterations, randomizing them to pembrolizumab alone or in combination with datopotamab deruxtecan, a TROP2-directed antibody-drug conjugate delivering a topoisomerase I inhibitor. Prior immune checkpoint inhibitor or TROP2-targeted therapy is not allowed.

ClinicalTrials.gov ID: NCT05215340

A Phase 2 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Patients With Stage 4 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.

HealthScout AI summary: This trial enrolls adults with untreated stage 4 non-small cell lung cancer (both squamous and non-squamous, without actionable oncogenic drivers) who receive EIK1001—a dual TLR7/8 agonist that activates dendritic cells—combined with pembrolizumab and standard platinum-doublet chemotherapy according to histology.

ClinicalTrials.gov ID: NCT06246110