Clinical Trials for Non-Small Cell Lung Cancer

A Randomized, Phase 2/3 Study to Evaluate the Optimal Dose, Safety, and Efficacy of Livmoniplimab in Combination With Budigalimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Untreated Metastatic Non-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

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 metastatic non-squamous NSCLC lacking actionable driver mutations, randomizing them to receive either livmoniplimab (anti-GARP/TGF-β1) plus budigalimab (anti-PD-1) with platinum-based chemotherapy, or pembrolizumab (anti-PD-1) with chemotherapy. The investigational regimen aims to enhance anti-tumor immune activity by targeting both PD-1 and Treg-mediated immunosuppression.

ClinicalTrials.gov ID: NCT06236438

A Phase II, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Volrustomig Priming Regimens in Combination With Other Anticancer Agents in Participants With Solid Tumors (eVOLVE-01)

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 treatment-naïve patients with stage IV non-squamous NSCLC (ECOG 0–1, no EGFR or other driver mutations) and randomizes them to one of two volrustomig priming regimens (a novel PD-1/CTLA-4 bispecific antibody) in combination with carboplatin and pemetrexed. Patients with stable, asymptomatic brain metastases may also be eligible.

ClinicalTrials.gov ID: NCT06448754

A Phase 2, Open-Label, Randomized, Global Study of Two Telisotuzumab Vedotin Regimens in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous 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: Eligible patients are adults with previously treated, locally advanced or metastatic non-squamous NSCLC that is c-Met overexpressing (by IHC) and EGFR wildtype, who have received 1 prior cytotoxic chemotherapy regimen and have good performance status. Participants are randomized to two regimens of telisotuzumab vedotin, an investigational antibody-drug conjugate targeting c-Met and delivering the cytotoxic agent MMAE.

ClinicalTrials.gov ID: NCT06568939

A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous 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.

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 treated, c-Met overexpressing, EGFR wildtype, locally advanced or metastatic non-squamous NSCLC, randomized to receive either telisotuzumab vedotin—an antibody-drug conjugate targeting c-Met—or standard docetaxel. Eligible patients must have had prior platinum-based chemotherapy and immunotherapy if appropriate, with stable CNS metastases permitted.

ClinicalTrials.gov ID: NCT04928846

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.

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 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

HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic 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

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: Adults with measurable, unresectable locally advanced or metastatic solid tumors that have progressed after standard therapies, enrolled in tumor-specific refractory cohorts (e.g., melanoma post–PD-(L)1, SCCHN post platinum/PD-(L)1, HER2-negative gastric/GEJ, HGS ovarian, cervical, endometrial, urothelial, ESCC, pancreatic, mCRPC, nonsquamous NSCLC without drivers, and HR+/HER2– breast cancer after CDK4/6 and chemo). Single-arm therapy is patritumab deruxtecan (HER3-DXd) 5.6 mg/kg IV q3w, an HER3-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor (DXd).

ClinicalTrials.gov ID: NCT06172478

A Phase 2/3 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous 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: Adults with untreated, locally advanced unresectable or metastatic EGFR-mutated non-squamous NSCLC (ECOG 0–1) are randomized to telisotuzumab adizutecan (c-Met–targeting ADC delivering a topoisomerase I inhibitor) plus fixed-dose osimertinib versus comparator regimens (osimertinib alone in Phase 2; standard of care in Phase 3), with c-Met IHC–based stratification. Key exclusions include prior/active ILD, leptomeningeal disease, and uncontrolled spinal cord compression.

ClinicalTrials.gov ID: NCT07005102

A Phase II, Multicenter, Open-Label Trial of DB-1311 in Combination With BNT327 or DB-1305 in Participants With Advanced/Metastatic 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

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: Enrolls adults with advanced/metastatic solid tumors—HCC (Child-Pugh A), cervical, melanoma, recurrent/metastatic HNSCC, platinum‑resistant high‑grade serous ovarian, and nonsquamous NSCLC without actionable drivers—ECOG 0–1 and measurable disease. Investigational therapy pairs the B7‑H3–targeted topoisomerase‑I ADC DB‑1311 with either BNT327 (PD‑L1/VEGF‑A bispecific) for HCC/cervical/melanoma/HNSCC or with the TROP2‑directed topoisomerase‑I ADC DB‑1305 for NSCLC.

ClinicalTrials.gov ID: NCT06953089

An Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumour Activity of Novel Combinations in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (LIBRA)

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: Adults with locally advanced/metastatic NSCLC enrolled by biomarker and line: first-line AGA-negative with PD-L1 ≥50% get rilvegostomig (PD‑1/TIGIT bispecific) ± ramucirumab, first-line AGA-negative with PD-L1 1–49% get rilvegostomig + ramucirumab, and second-line AGA-positive nonsquamous post–targeted therapy get datopotamab deruxtecan (TROP2 ADC) + ramucirumab ± rilvegostomig. Designed to assess safety and antitumor activity across these combinations, excluding patients with active autoimmune disease, uncontrolled comorbidities, or unstable CNS disease.

ClinicalTrials.gov ID: NCT07098338

An Open-label Study to Assess the Safety and Efficacy of Naporafenib (ERAS-254) Administered With Trametinib in Previously Treated Patients With Locally Advanced Unresectable or Metastatic Solid Tumor Malignancies With RAS Q61X Mutations

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 assesses the safety and efficacy of naporafenib, a pan-RAF kinase inhibitor, combined with trametinib, a MEK inhibitor, in patients aged 12 and older with previously treated, RAS Q61X-mutated locally advanced unresectable or metastatic solid tumors lacking standard treatment options. Patients with neurologically unstable primary CNS tumors or CNS metastases are excluded.

ClinicalTrials.gov ID: NCT05907304