Clinical Trials for Small Cell Lung Cancer

A Randomized, Open-Label, Multicenter, Phase 3 Study Evaluating the Efficacy and Safety of IBI363 Versus Docetaxel in Participants With Unresectable Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer With Disease Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 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

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.

TrialFetch AI summary: Adults with unresectable locally advanced or metastatic squamous NSCLC that has progressed after platinum chemotherapy and PD-1/PD-L1 immunotherapy are randomized to IBI363 or docetaxel. IBI363 is an investigational PD-1 antibody fused to an IL-2 mutein, designed to combine checkpoint blockade with targeted IL-2 signaling.

ClinicalTrials.gov ID: NCT07217301

Phase II Dose Optimization Study of Platinum/Etoposide Plus Ivonescimab (CEI) as First-Line Treatment of Extensive-Stage 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.

TrialFetch AI summary: Adults with untreated extensive-stage small cell lung cancer, measurable disease, and ECOG performance status 0–1 receive first-line carboplatin/etoposide plus either 10 or 20 mg/kg of ivonescimab, followed by ivonescimab maintenance. Ivonescimab is a bispecific antibody targeting PD-1 and VEGF-A; there is no chemotherapy-only arm.

ClinicalTrials.gov ID: NCT07057791

A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody-Drug Conjugate (ADC), Compared to Investigator's Choice Therapy in Participants With Relapsed 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.

TrialFetch AI summary: Adults with measurable small-cell lung cancer that progressed during or after platinum-based therapy and ECOG performance status 0–1 are randomized to ZL-1310 or investigator’s choice therapy. ZL-1310 is a DLL3-targeting antibody–drug conjugate that delivers a topoisomerase I inhibitor payload; prior tarlatamab is permitted, but prior ADCs with a topoisomerase I inhibitor payload are excluded.

ClinicalTrials.gov ID: NCT07218146

A Phase II Trial of Telisotuzumab Vedotin With Osimertinib for EGFR Mutated NSCLC With c-MET Overexpression That is Progressing on Osimertinib

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.

TrialFetch AI summary: Adults with incurable EGFR-mutated NSCLC and intermediate or high c-MET expression after progression on an osimertinib-containing regimen receive continued osimertinib plus telisotuzumab vedotin. Telisotuzumab vedotin is a c-MET–directed antibody–drug conjugate that delivers the microtubule inhibitor MMAE to c-MET–expressing cells.

ClinicalTrials.gov ID: NCT07323641

ROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With PD-L1 ≥ 50%.

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.

TrialFetch AI summary: For patients with previously untreated stage IIIB/IIIC or IV NSCLC, PD-L1 expression ≥50%, and ECOG performance status 0–1, this study compares first-line pumitamig monotherapy with pembrolizumab. Pumitamig is an investigational bispecific antibody targeting PD-L1 and VEGF-A; patients with actionable alterations warranting approved first-line therapy are excluded.

ClinicalTrials.gov ID: NCT07361510

DAREON ® -Lung-1: A Phase III Multi-center, Open-label, Randomised Trial of Intravenous Obrixtamig in Combination With Atezolizumab, Carboplatin, and Etoposide vs. Atezolizumab, Carboplatin, and Etoposide as First-line Treatment in Patients With Extensive-stage 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.

TrialFetch AI summary: This trial enrolls adults with previously untreated extensive-stage small-cell lung cancer, ECOG performance status 0–1, and a central DLL3 test result. It compares first-line atezolizumab, carboplatin, and etoposide with or without obrixtamig, an investigational DLL3×CD3 bispecific T-cell engager.

ClinicalTrials.gov ID: NCT07472517

A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer (TeLuRide-008).

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.

TrialFetch AI summary: Adults with previously untreated stage IV squamous or nonsquamous NSCLC, ECOG 0–1, and no actionable alteration with an approved first-line targeted therapy receive pembrolizumab and histology-appropriate platinum-based chemotherapy plus either EIK1001 or placebo. EIK1001 is an investigational TLR7/8 agonist intended to stimulate innate immune signaling and antigen presentation.

ClinicalTrials.gov ID: NCT07365319

A Randomized, Double-blind, Phase 3 Study of Pembrolizumab + Pemetrexed + Platinum Chemotherapy With or Without Zoldonrasib (RMC-9805) as First Line Treatment in Patients With Metastatic Non-squamous RAS G12D-Mutated Non-small Cell Lung Cancer (RASolve 308)

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.

TrialFetch AI summary: Adults with previously untreated metastatic nonsquamous NSCLC harboring a RAS G12D mutation receive first-line pembrolizumab, pemetrexed, and cisplatin or carboplatin plus either zoldonrasib or placebo. Zoldonrasib is an investigational inhibitor of active KRAS G12D that suppresses downstream RAS signaling.

ClinicalTrials.gov ID: NCT07777822

A Phase 3 Randomized, Open Label, Multicenter Study to Evaluate the Safety and Efficacy of ABBV-706 Versus Standard of Care in Subjects With Relapsed/Refractory Small Cell Lung Cancer (SCLC)

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.

TrialFetch AI summary: Adults with relapsed or refractory SCLC after prior systemic therapy, generally including platinum-etoposide plus a checkpoint inhibitor when eligible and tarlatamab, are randomized to intravenous ABBV-706 or investigator-selected topotecan, lurbinectedin, or amrubicin. ABBV-706 is an investigational SEZ6-targeted antibody–drug conjugate that delivers a topoisomerase I inhibitor payload.

ClinicalTrials.gov ID: NCT07365241

Phase 3, Multicenter, Randomized, Open-label Clinical Study of GSK5764227, a B7-H3 Antibody Drug Conjugate (ADC), Compared With Topotecan in Participants With Relapsed Small Cell Lung Cancer (SCLC)

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.

TrialFetch AI summary: Adults with relapsed extensive-stage SCLC after one platinum-based regimen plus a PD-(L)1 inhibitor, ECOG 0–1, and a chemotherapy-free interval over 30 days are randomized to risvutatug rezetecan or topotecan. Risvutatug rezetecan is an investigational B7-H3–targeted antibody-drug conjugate carrying a topoisomerase inhibitor payload.

ClinicalTrials.gov ID: NCT07099898