Clinical Trials for Small Cell Lung Cancer

AN INTERVENTIONAL PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS PEMBROLIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC 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.

TrialFetch AI summary: Adults with unresectable stage IIIB/IIIC or metastatic stage IV squamous or non-squamous NSCLC without actionable driver alterations, systemic-therapy naïve for advanced disease (ECOG 0–1, measurable disease, known PD-L1 status), are randomized to PF-08634404/SSGJ-707 (investigational bispecific antibody targeting PD-1 and VEGF) plus histology-appropriate platinum-based chemotherapy followed by maintenance, versus pembrolizumab plus the same chemotherapy followed by standard maintenance. Primary outcomes compare overall survival and centrally reviewed PFS between regimens.

ClinicalTrials.gov ID: NCT07222566

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 (ECOG 0–1, RECIST-measurable) whose disease progressed during or within 6 months after prior anti–PD-1/PD-L1 therapy and after platinum-doublet chemotherapy are randomized 1:1 to IBI363 vs docetaxel. IBI363 is a PD-1–blocking bispecific fusion protein delivering a CD25-biased IL-2 mutein to stimulate tumor-reactive T/NK cells, given IV Q3W after a priming dose, compared with standard docetaxel 75 mg/m² IV Q3W.

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: Enrolling adults with previously untreated extensive-stage small cell lung cancer, measurable disease (RECIST v1.1), ECOG 0–1, and adequate organ function, excluding symptomatic/high-risk CNS metastases and patients with significant bleeding/vascular risk or active autoimmune disease requiring systemic therapy. Patients are randomized to carboplatin/etoposide plus ivonescimab 10 mg/kg vs 20 mg/kg for 4 induction cycles, then ivonescimab maintenance; ivonescimab is a tetravalent bispecific antibody targeting PD-1 and VEGF (checkpoint blockade plus anti-angiogenic activity).

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 histologically/cytologically confirmed SCLC who progressed during/after one prior platinum-based regimen (prior 2L tarlatamab allowed), with RECIST-measurable disease, ECOG 0–1, and allowing treated/stable or asymptomatic CNS metastases. Patients are randomized to ZL-1310, a DLL3-targeted antibody–drug conjugate delivering a camptothecin-derived topoisomerase I inhibitor payload, versus investigator’s choice standard therapy.

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: Single-arm study for adults with incurable EGFR-mutated, predominantly adenocarcinoma NSCLC with c-MET overexpression after progression on osimertinib, ECOG 0–1, measurable disease, and no active/symptomatic CNS disease or significant ILD/pneumonitis. Patients continue osimertinib 80 mg daily with telisotuzumab vedotin, a c-MET–directed antibody-drug conjugate delivering the microtubule inhibitor MMAE.

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: Randomized first-line study for adults with unresectable stage IIIB/IIIC or stage IV squamous or nonsquamous NSCLC, PD-L1 ≥50%, ECOG 0–1, measurable disease, and no actionable driver alterations or prior systemic therapy for advanced disease. Participants receive pumitamig/BNT327, an investigational bispecific antibody targeting PD-L1 and VEGF-A, versus standard pembrolizumab monotherapy.

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: Randomized first-line trial for adults with untreated extensive-stage SCLC, ECOG 0–1, with tumor tissue available for DLL3 testing; stable treated or untreated brain metastases may be allowed. Patients receive atezolizumab/carboplatin/etoposide with or without obrixtamig, an IV DLL3×CD3 bispecific T-cell engager that redirects T cells against DLL3-expressing tumor cells.

ClinicalTrials.gov ID: NCT07472517

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.

TrialFetch 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.

TrialFetch 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

Phase II Trial of LP-300 in Combination with Carboplatin and Pemetrexed in Never Smoker Patients with Relapsed Advanced Primary Adenocarcinoma of the Lung After Treatment with Tyrosine Kinase Inhibitors (The HARMONIC Study)

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: The trial is for never smoker patients with relapsed advanced primary adenocarcinoma of the lung, featuring actionable genomic alterations, who have progressed after tyrosine kinase inhibitor therapies. It examines the combination of the investigational multi-tyrosine kinase receptor inhibitor LP-300 with carboplatin and pemetrexed, compared to the standard carboplatin-pemetrexed regimen.

ClinicalTrials.gov ID: NCT05456256