Clinical Trials for Small Cell Lung Cancer

A Phase III, Multisite, Double-blinded Randomized Trial of BNT327 in Combination With Chemotherapy (Etoposide/Carboplatin) Compared to Atezolizumab in Combination With Chemotherapy (Etoposide/Carboplatin) in Participants With First-line 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 previously untreated extensive-stage small-cell lung cancer (ECOG 0–1, measurable disease; prior curative-intent chemoradiotherapy for limited-stage allowed if ≥6 months since treatment) are randomized to platinum/etoposide plus pumitamig (BNT327; investigational PD-L1/VEGF-A bispecific antibody combining checkpoint blockade with anti-angiogenic activity) versus the standard atezolizumab plus platinum/etoposide, followed by maintenance with the assigned immunotherapy. Patients with combined SCLC histology, prior PD-(L)1/VEGF-targeted therapy, high bleeding/wound-healing risk, or untreated/symptomatic/large CNS metastases/leptomeningeal disease are excluded.

ClinicalTrials.gov ID: NCT06712355

A GLOBAL PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS 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: Enrolling adults with treatment-naïve extensive-stage small cell lung cancer (ECOG 0–1) and measurable disease, allowing prior curative-intent therapy for limited-stage SCLC if completed ≥6 months earlier, and excluding active CNS metastases/leptomeningeal disease and significant bleeding/fistula risk. Patients receive IV PF-08634404/SSGJ-707 (bispecific anti–PD-1/anti-VEGF antibody combining checkpoint inhibition with anti-angiogenic blockade) plus platinum/etoposide with possible maintenance, compared with atezolizumab plus the same chemotherapy backbone.

ClinicalTrials.gov ID: NCT07226999

A Phase 2, Open-label, Multicohort Study of Rinatabart Sesutecan (Rina-S) in Participants With 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 locally advanced or metastatic non-squamous NSCLC (adenocarcinoma only), ECOG 0–1, measurable disease, and radiographic progression after their most recent therapy (with or without actionable genomic alterations; stable treated brain metastases allowed). Single-arm treatment is rinatabart sesutecan monotherapy q3 weeks, an FRα-targeting antibody–drug conjugate delivering a topoisomerase I inhibitor payload, continued until progression or unacceptable toxicity.

ClinicalTrials.gov ID: NCT07288177

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

TACTI-004, a Double-Blinded, Randomized Phase 3 Trial in Patients With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Receiving Eftilagimod Alfa (MHC Class II Agonist) in Combination With Pembrolizumab (PD-1 Antagonist) and Chemotherapy.

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 IIIB/C or IV NSCLC not amenable to curative therapy (ECOG 0–1; PD-L1 unselected; excluding EGFR-sensitizing mutations, ALK fusions, or ROS1 translocations; treated/stable brain metastases allowed) are randomized to add eftilagimod alfa (soluble LAG-3–Ig fusion protein, MHC class II agonist that activates antigen-presenting cells to enhance T-cell priming) or placebo to standard first-line pembrolizumab plus histology-appropriate platinum-doublet chemotherapy. Primary outcomes are overall survival and RECIST 1.1 progression-free survival.

ClinicalTrials.gov ID: NCT06726265

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

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