Clinical Trials for Non-Small Cell Lung Cancer

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.

TrialFetch AI summary: Adults with previously untreated stage IV nonsquamous NSCLC, ECOG 0–1, and no actionable driver with an approved first-line targeted therapy receive a priming dose of volrustomig, an investigational PD-1/CTLA-4 bispecific antibody, followed by one of two volrustomig dosing regimens with carboplatin and pemetrexed. There is no standard-of-care comparator arm.

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.

TrialFetch AI summary: Adults with previously treated, locally advanced or metastatic c-Met–overexpressing, EGFR-wild-type nonsquamous NSCLC are randomized to one of two intravenous telisotuzumab vedotin regimens. Telisotuzumab vedotin is a c-Met–directed antibody–drug conjugate that delivers the microtubule-disrupting payload monomethyl auristatin E.

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.

TrialFetch AI summary: Adults with previously treated, locally advanced or metastatic nonsquamous NSCLC with centrally confirmed c-Met overexpression and EGFR wild-type disease are randomized to telisotuzumab vedotin or docetaxel. Telisotuzumab vedotin is a c-Met–directed antibody–drug conjugate that delivers the microtubule inhibitor monomethyl auristatin E.

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.

TrialFetch AI summary: Adults with ECOG 0–1 and previously treated, refractory, locally advanced unresectable or metastatic solid tumors across multiple tumor-specific cohorts receive patritumab deruxtecan 5.6 mg/kg IV every 3 weeks. This investigational HER3-targeted antibody–drug conjugate delivers an exatecan-derived topoisomerase I inhibitor payload.

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.

TrialFetch AI summary: Adults with previously untreated, locally advanced unresectable or metastatic EGFR-mutated nonsquamous NSCLC and ECOG 0–1 are randomized to osimertinib alone or osimertinib plus telisotuzumab adizutecan. Telisotuzumab adizutecan is an investigational c-Met–targeting antibody–drug conjugate that delivers a topoisomerase I inhibitor.

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.

TrialFetch AI summary: Adults with measurable recurrent or advanced/metastatic hepatocellular, cervical, melanoma, head and neck squamous, platinum-resistant high-grade serous ovarian, or non-small cell lung cancer and ECOG 0–1 receive DB-1311, a B7-H3–targeted topoisomerase I inhibitor antibody–drug conjugate. It is combined with either BNT327, a PD-L1/VEGF-A bispecific antibody, or DB-1305, a TROP2-targeted topoisomerase I inhibitor antibody–drug conjugate.

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.

TrialFetch AI summary: Adults with locally advanced or metastatic NSCLC and ECOG 0–1 are enrolled in first-line cohorts without known actionable alterations (PD-L1 ≥1%) or a second-line nonsquamous cohort with actionable alterations after progression on targeted therapy. First-line treatment is rilvegostomig (a PD-1/TIGIT bispecific antibody) with or without ramucirumab (anti-VEGFR2), depending on PD-L1 expression; second-line treatment is datopotamab deruxtecan (a TROP2-directed, topoisomerase I inhibitor–delivering antibody–drug conjugate) plus ramucirumab, with or without rilvegostomig.

ClinicalTrials.gov ID: NCT07098338

A Phase 2 Platform Study of Immunomodulatory Compounds in ICI-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.

TrialFetch AI summary: Adults with locally advanced or metastatic NSCLC that progressed after at least six weeks of anti-PD-(L)1 therapy receive single-agent SAR445877 every 14 days. SAR445877 combines PD-1 blockade with a reduced-activity IL-15 complex designed to preferentially stimulate PD-1–expressing immune cells.

ClinicalTrials.gov ID: NCT07133425

KEYMAKER-U01 Substudy 01J: A Randomized Phase 2 Umbrella Study With Rolling Arms of Investigational Agents for First-line Treatment of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations

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.

TrialFetch AI summary: This trial enrolls previously untreated patients with advanced or metastatic nonsquamous NSCLC harboring a KRAS G12C mutation. It compares pembrolizumab plus carboplatin/pemetrexed with pembrolizumab plus investigational calderasib (MK-1084), a covalent KRAS G12C inhibitor, with or without cetuximab.

ClinicalTrials.gov ID: NCT07252739

A Phase 2 Study to Investigate Ubamatamab With and Without REGN7075 in Treatment-Experienced Participants With Advanced/Metastatic 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.

TrialFetch AI summary: For patients with previously treated unresectable stage IIIB/IIIC or metastatic NSCLC and ECOG 0–1, this study evaluates ubamatamab, a MUC16 × CD3 T-cell–engaging bispecific antibody, with or without REGN7075, an EGFR × CD28 T-cell–costimulating bispecific antibody. Sarilumab is included to manage immune-related adverse effects.

ClinicalTrials.gov ID: NCT07154290