Clinical Trials for Small Cell Lung Cancer

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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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

PRISM: PRecIsion in SCLC Via a Multicohort Study: Randomized Phase II Studies Evaluating Maintenance Durvalumab With or Without Biomarker-Directed Therapy for Extensive Stage Small Cell Lung Cancer (ES-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 extensive-stage SCLC who have not progressed after induction platinum–etoposide plus durvalumab and have adequate tissue for central subtyping (A/N/I/P) and SLFN11 testing are randomized to durvalumab maintenance alone versus durvalumab plus a biomarker-directed agent: PARP1 inhibitor saruparib for subtype P or SLFN11+ A/N; ATR inhibitor ceralasertib for SLFN11– A/N; or NKG2A inhibitor monalizumab for subtype I. Treated, stable brain metastases allowed; leptomeningeal disease excluded.

ClinicalTrials.gov ID: NCT06769126

A Phase III, Randomised, Open-Label, Multicentre Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung17)

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 stage IIIB/IIIC–IV TROP2 (NMR)-positive non-squamous NSCLC without actionable genomic alterations (EGFR/ALK/ROS1 negative and no other actionable drivers), ECOG 0–1, with RECIST-measurable progression after platinum chemotherapy and anti–PD-1/PD-L1 therapy. Randomized to datopotamab deruxtecan (TROP2-directed antibody–drug conjugate delivering a topoisomerase I inhibitor payload) IV q3w versus docetaxel IV q3w.

ClinicalTrials.gov ID: NCT07291037

Ph 2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab and Nivolumab With or Without Docetaxel Versus Docetaxel in 2L Treatment of Participants With Metastatic NSCLC (GDFATHER-NSCLC-02)

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 metastatic stage IV non-squamous NSCLC without actionable drivers, ECOG 0–1, measurable disease, who progressed on exactly one first-line regimen containing anti–PD-(L)1 therapy while still receiving it (checkpoint-inhibitor–refractory) in the 2L setting. Randomized, blinded Q3W IV comparison of visugromab (anti–GDF-15 mAb intended to reverse PD-1 resistance by restoring T-cell trafficking) + nivolumab with or without docetaxel versus docetaxel alone (with placebo controls).

ClinicalTrials.gov ID: NCT07246863

Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan Compared to Standard of Care in Subjects With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer After Progression on a Third-Generation EGFR TKI

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/metastatic non-squamous NSCLC harboring EGFR exon 19 del or L858R (ECOG 0–1) with measurable disease and radiographic progression after exactly one prior third-generation EGFR TKI (including adjuvant; stable/asymptomatic treated CNS mets allowed) are randomized to telisotuzumab adizutecan (ABBV-400), a c-Met–targeting ADC delivering a cleavable-linker topoisomerase I inhibitor payload, versus investigator’s choice standard-of-care therapy. The study includes two telisotuzumab adizutecan dose levels initially to select the RP3D, then compares RP3D against standard care.

ClinicalTrials.gov ID: NCT07155187

A Phase 2 Randomized, Open Label, Multicenter Study to Evaluate the Optimal Dose, Safety, and Efficacy of ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Subjects With Previously Untreated Extensive Stage Small Cell Lung Cancer (ES-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: Enrolling adults with previously untreated extensive-stage SCLC (ECOG 0–1, measurable disease) without active/symptomatic CNS metastases and without steroid-requiring or active ILD/pneumonitis. Participants are randomized to ABBV-706 (SEZ6-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor payload) at one of two IV dose levels plus atezolizumab versus standard carboplatin/etoposide plus atezolizumab (optional lurbinectedin per protocol).

ClinicalTrials.gov ID: NCT07155174

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