Clinical Trials for Small Cell Lung Cancer

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 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 Ph2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab Versus Placebo, in Combination With Pembrolizumab, Pemetrexed, and Carboplatin, in 1L Treatment of Participants With Metastatic NSCLC (GDFATHER-NSCLC-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

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 newly diagnosed metastatic non-squamous NSCLC (ECOG 0–1) lacking actionable driver mutations receive pembrolizumab+pemetrexed+carboplatin with either visugromab or placebo; PD-L1 ≥50% allowed only when CPI monotherapy isn’t appropriate. Visugromab is a humanized anti–GDF-15 monoclonal antibody intended to enhance T-cell trafficking and overcome PD-(L)1 resistance.

ClinicalTrials.gov ID: NCT07098988

A Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With First-Line Osimertinib Treatment and Harbor a C797S Mutation

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 locally advanced/metastatic EGFR-mutant NSCLC who progressed on first-line osimertinib via acquired EGFR C797S (including patients with stable brain mets) receive oral WSD0922-FU BID. WSD0922-FU is a brain-penetrant, reversible, non-ATP-competitive EGFR inhibitor designed to target sensitizing EGFR mutations and EGFRm/C797S with relative selectivity over wild-type EGFR.

ClinicalTrials.gov ID: NCT06868485

A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)

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 treatment‑naive, advanced/metastatic nonsquamous NSCLC harboring KRAS G12C are randomized to MK‑1084 (a selective covalent KRAS G12C inhibitor) plus subcutaneous pembrolizumab with berahyaluronidase alfa versus subcutaneous pembrolizumab with berahyaluronidase alfa plus pemetrexed and platinum chemotherapy. Primary analysis focuses on PFS (BICR) in PD‑L1 TPS ≥1%, with key secondary endpoints including PFS/OS in all-comers and response outcomes.

ClinicalTrials.gov ID: NCT07190248

A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Patients With Previously Untreated, KRAS G12C-Mutated, Advanced or 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.

HealthScout AI summary: Untreated adults with advanced/metastatic non-squamous NSCLC harboring KRAS G12C (ECOG 0–1) are randomized to divarasib (selective, irreversible KRAS G12C inhibitor) plus pembrolizumab versus standard pembrolizumab plus platinum/pemetrexed. Excludes other actionable drivers, prior KRAS/IO therapy, and active CNS disease; endpoints include PFS and OS.

ClinicalTrials.gov ID: NCT06793215

A RANDOMIZED, PHASE 3, OPEN-LABEL STUDY TO EVALUATE PF-08046054/SGN-PDLlV VERSUS DOCETAXEL IN ADULT PARTICIPANTS WITH PREVIOUSLY-TREATED PROGRAMMED CELL DEATH LIGAND 1 (PD-Ll) POSITIVE 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

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 PD-L1–positive (≥1%) unresectable stage IIIB/IIIC or metastatic NSCLC who have progressed after PD-(L)1 therapy and platinum chemotherapy (and after appropriate targeted therapy for actionable alterations) are randomized to PF-08046054 (SGN-PDL1V), a PD-L1–targeted antibody–drug conjugate delivering the microtubule toxin MMAE, versus docetaxel. Excludes neuroendocrine histology, active CNS disease requiring >10 mg prednisone equivalent, leptomeningeal disease, prior MMAE agents, or prior docetaxel.

ClinicalTrials.gov ID: NCT07144280

A Study of Open-label Orally Administered JBI-802 Alone or in Combination With Pembrolizumab in Patients With Advanced NSCLC Tumors Harboring an STK11 Mutation

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 advanced/metastatic NSCLC harboring an STK11 mutation (ECOG 0–2) receive oral JBI-802, a first-in-class dual LSD1/HDAC6 inhibitor targeting the CoREST complex, either as monotherapy or combined with pembrolizumab. Key exclusions include unstable CNS disease, significant cardiac comorbidities, active infections, QTcF >480 ms, recent therapy, and strong CYP3A/CYP2D6 modulators.

ClinicalTrials.gov ID: NCT07207395

A Randomized Phase 2/3 Study of BMS-986504 in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion

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 metastatic NSCLC (ECOG 0–1) harboring homozygous MTAP deletion/MTAP loss are randomized to pembrolizumab plus platinum-doublet chemotherapy with or without BMS-986504, an oral selective MTA-cooperative PRMT5 inhibitor exploiting MTAP-deletion synthetic lethality. Nonsquamous patients with targetable first-line drivers are excluded; standard pemetrexed- or taxane-based platinum regimens are used by histology.

ClinicalTrials.gov ID: NCT07063745