Clinical Trials for Small Cell Lung Cancer

A Randomized, Open-Label, Phase 3 Study to Evaluate Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy for the First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer With No Epidermal Growth Factor Receptor or Anaplastic Lymphoma Kinase Genomic Tumor Aberrations

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.

HealthScout AI summary: This trial enrolls adults with newly diagnosed stage IV NSCLC without EGFR, ALK, ROS1, NTRK, BRAF, RET, or other actionable mutations, randomizing them to standard chemotherapy plus either pembrolizumab (PD-1 inhibitor), zimberelimab (PD-1 inhibitor), or zimberelimab combined with domvanalimab (TIGIT inhibitor) as first-line therapy. Eligible patients must have good performance status (ECOG 0-1) and no prior immune checkpoint inhibitor exposure.

ClinicalTrials.gov ID: NCT05502237

A Multicenter, Randomized, Open-label, Phase 2 Study Evaluating the Safety and Efficacy of BMS-986504 Monotherapy in Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion After Progression on Prior Therapies

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.

HealthScout AI summary: Eligible patients are adults with advanced or metastatic NSCLC harboring homozygous MTAP deletion and disease progression after prior systemic therapies; the trial randomizes participants to two oral dosing regimens of BMS-986504, a selective PRMT5 inhibitor that targets MTAP-deleted tumors through synthetic lethality.

ClinicalTrials.gov ID: NCT06855771

A Phase 2 Evaluation of the Safety and Efficacy of AL8326 in ≥2nd Line Small Cell Lung Cancer (SCLC) Treatment

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.

HealthScout AI summary: Adults with recurrent/advanced SCLC needing ≥2nd-line therapy (ECOG 0–1; controlled brain mets allowed) receive continuous oral AL8326 at randomized dose levels to define an optimal biological dose and assess antitumor activity. AL8326 is an investigational multi-target receptor tyrosine kinase inhibitor with anti-angiogenic activity (VEGFR/FGFR; possible Aurora B), continued until progression or toxicity.

ClinicalTrials.gov ID: NCT05363280

A Phase II Trial of MOnaliZumab in Combination With durvAlumab (MEDI4736) Plus Platinum-based chemotheRapy for First-line Treatment of Extensive Stage Small Cell Lung Cancer (MOZART)

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.

HealthScout AI summary: Untreated extensive-stage small cell lung cancer (including stable treated or asymptomatic brain mets; ECOG 0–2) receives durvalumab plus platinum–etoposide with added monalizumab, an investigational anti-NKG2A antibody that augments NK and CD8 T-cell activity, followed by durvalumab/monalizumab maintenance. Prior systemic therapy is not allowed except up to one recent cycle of platinum ± durvalumab.

ClinicalTrials.gov ID: NCT05903092

A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice (TPC) in Subjects With Relapsed Small Cell Lung Cancer (SCLC) (IDeate-Lung02)

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.

HealthScout AI summary: Adults with extensive-stage SCLC who have relapsed after exactly one prior platinum-based regimen (ECOG 0–1, measurable disease, no active/untreated CNS disease) are randomized to ifinatamab deruxtecan, a B7-H3–targeted antibody–drug conjugate delivering a topoisomerase I inhibitor, versus physician’s choice (topotecan, lurbinectedin, or amrubicin). Key exclusions include prior B7-H3 therapy, prior topoisomerase I inhibitor, ILD/pneumonitis, significant cardiac or corneal disease.

ClinicalTrials.gov ID: NCT06203210

A Phase 2 Study of Alisertib 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.

HealthScout AI summary: Single-arm study of oral alisertib, a selective Aurora A kinase inhibitor, as monotherapy for adults with ES-SCLC who progressed after platinum plus anti–PD-L1 (≤2 prior lines total). Patients receive alisertib 50–60 mg BID on days 1–7 of 21-day cycles; efficacy will be assessed overall and in predefined biomarker subgroups.

ClinicalTrials.gov ID: NCT06095505

A Randomized, Double Blind, Multicenter Phase 3 Trial of BMS-986489 (BMS-986012+Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide vs Atezolizumab in Combination With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).

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.

HealthScout AI summary: Untreated adults with extensive-stage SCLC (measurable extracranial disease, good performance status) are randomized to carboplatin/etoposide plus a fixed-dose of BMS-986489 (BMS-986012, an afucosylated anti–fucosyl-GM1 IgG1 enhancing ADCC/CDC/ADCP, combined with the PD-1 inhibitor nivolumab) versus standard carboplatin/etoposide plus the PD-L1 inhibitor atezolizumab. Primary endpoint is overall survival, with key exclusions including prior ES-SCLC therapy, unstable CNS disease, significant cardiopulmonary disease, active autoimmune disease requiring immunosuppression, and significant neuropathy.

ClinicalTrials.gov ID: NCT06646276

A Multi-center Phase II Study of Ipatasertib in Combination With Docetaxel in Metastatic/Advanced NSCLC Patients Who Have Failed or Are Intolerant to 1st Line Immunotherapy (Ipat-Lung)

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 involves adult patients with advanced or metastatic NSCLC who have not responded to or cannot tolerate first-line anti-PD1/PD-L1 therapies and lack targetable mutations, testing the efficacy of the pan-AKT inhibitor ipatasertib in combination with docetaxel.

ClinicalTrials.gov ID: NCT04467801

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.

HealthScout 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.

HealthScout 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