Clinical Trials for Non-Small Cell Lung Cancer

KEYMAKER-U01 Substudy 01H: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (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.

HealthScout AI summary: This trial enrolls adults with stage IV nonsquamous NSCLC who have progressed after both anti-PD-(L)1 therapy and platinum-based chemotherapy, randomizing them to receive either raludotatug deruxtecan (a CDH6-targeting antibody-drug conjugate), ifinatamab deruxtecan (a B7-H3-targeting antibody-drug conjugate), or standard docetaxel. Patients with EGFR, ALK, or ROS1 alterations eligible for targeted therapy are excluded.

ClinicalTrials.gov ID: NCT06780085

A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab Monotherapy for the First-line Treatment of Patients With PD-L1-high Metastatic Non-small Cell Lung Cancer (ARTEMIDE-Lung04)

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.

HealthScout AI summary: This trial enrolls adults with previously untreated, PD-L1-high metastatic non-small cell lung cancer (any histology, no EGFR/ALK/ROS1 alterations) and compares rilvegostomig, a bispecific antibody targeting PD-1 and TIGIT, to pembrolizumab monotherapy.

ClinicalTrials.gov ID: NCT06868277

KEYMAKER-U01 Substudy 01I: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (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.

HealthScout AI summary: This trial enrolls adults with stage IV squamous NSCLC whose disease has progressed after both anti-PD-(L)1 immunotherapy and platinum chemotherapy, randomizing them to either standard docetaxel or investigational antibody-drug conjugates: Raludotatug deruxtecan (targeting CDH6) or Infinatamab deruxtecan (targeting B7-H3).

ClinicalTrials.gov ID: NCT06780098

A Randomized, Open-Label, Phase 3 Study to Evaluate Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy for the First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer With No Epidermal Growth Factor Receptor or Anaplastic Lymphoma Kinase Genomic Tumor Aberrations

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.

HealthScout AI summary: This trial enrolls adults with newly diagnosed stage IV NSCLC without EGFR, ALK, ROS1, NTRK, BRAF, RET, or other actionable mutations, randomizing them to standard chemotherapy plus either pembrolizumab (PD-1 inhibitor), zimberelimab (PD-1 inhibitor), or zimberelimab combined with domvanalimab (TIGIT inhibitor) as first-line therapy. Eligible patients must have good performance status (ECOG 0-1) and no prior immune checkpoint inhibitor exposure.

ClinicalTrials.gov ID: NCT05502237

A Multicenter, Randomized, Open-label, Phase 2 Study Evaluating the Safety and Efficacy of BMS-986504 Monotherapy in Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion After Progression on Prior Therapies

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.

HealthScout AI summary: Eligible patients are adults with advanced or metastatic NSCLC harboring homozygous MTAP deletion and disease progression after prior systemic therapies; the trial randomizes participants to two oral dosing regimens of BMS-986504, a selective PRMT5 inhibitor that targets MTAP-deleted tumors through synthetic lethality.

ClinicalTrials.gov ID: NCT06855771

A Multi-center Phase II Study of Ipatasertib in Combination With Docetaxel in Metastatic/Advanced NSCLC Patients Who Have Failed or Are Intolerant to 1st Line Immunotherapy (Ipat-Lung)

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 involves adult patients with advanced or metastatic NSCLC who have not responded to or cannot tolerate first-line anti-PD1/PD-L1 therapies and lack targetable mutations, testing the efficacy of the pan-AKT inhibitor ipatasertib in combination with docetaxel.

ClinicalTrials.gov ID: NCT04467801

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 Randomized, Double-blind, Placebo-controlled, Phase 2 Study Evaluating Efficacy and Safety of Inupadenant in Combination with Carboplatin and Pemetrexed in Adults with Nonsquamous Non-small Cell Lung Cancer Who Have Progressed on 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

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: The trial involves adults with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have progressed following first-line anti-PD-(L)1 therapy, investigating the efficacy and safety of inupadenant, a selective adenosine A2A receptor antagonist, in combination with carboplatin and pemetrexed compared to standard chemotherapy alone.

ClinicalTrials.gov ID: NCT05403385

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