Clinical Trials for Non-Small Cell Lung Cancer

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, Safety and Efficacy Study of PRT3789 in Combination With Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4 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

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 advanced or metastatic solid tumors harboring a deleterious SMARCA4 mutation or loss of SMARCA4 protein expression, specifically focusing on esophageal cancer and NSCLC for efficacy evaluation. Patients receive PRT3789, a selective SMARCA2 degrader exploiting synthetic lethality in SMARCA4-deficient tumors, in combination with pembrolizumab.

ClinicalTrials.gov ID: NCT06682806

A Phase II, Open-label, Platform Study, to Evaluate Immunotherapy-based Combinations in Participants With Advanced 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 stage IV metastatic NSCLC and good performance status to evaluate several immunotherapy-based combinations—including domvanalimab (TIGIT inhibitor), quemliclustat (CD73 inhibitor), and zimberelimab (anti-PD-1)—with or without platinum-based chemotherapy or docetaxel. Eligible patients should have measurable disease and no significant immunosuppression or active autoimmune disorders.

ClinicalTrials.gov ID: NCT05676931

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

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

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