Clinical Trials for Small Cell Lung Cancer

A Phase 2, Open-label, Multicohort Study of Rinatabart Sesutecan (Rina-S) in Participants With Non-Small Cell Lung Cancer

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

KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Previously Treated Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations

TrialFetch AI summary: Enrolling adults with advanced/metastatic nonsquamous NSCLC harboring KRAS G12C who have progressed after 1–2 prior lines including both PD-1/PD-L1 therapy and platinum chemotherapy, with no prior KRAS-targeted therapy and without active CNS disease or significant ILD/pneumonitis history. Patients are randomized to the investigational selective KRAS G12C-GDP covalent inhibitor MK-1084 combined with either patritumab deruxtecan (HER3-targeted topoisomerase I ADC), sacituzumab tirumotecan (TROP2-targeted topoisomerase I ADC), or cetuximab (EGFR monoclonal antibody).

ClinicalTrials.gov ID: NCT07286149

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

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

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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of V940 in Combination With Pembrolizumab and Chemotherapy as First-Line Treatment for Participants With Metastatic Squamous NSCLC (INTerpath-013)

TrialFetch AI summary: Adults with previously untreated stage IV metastatic squamous NSCLC (ECOG 0–1; measurable disease; requires non-irradiated metastatic tumor tissue for sequencing; controlled HIV and treated/undetectable HBV/HCV allowed) receive first-line pembrolizumab plus carboplatin and a taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab maintenance. Participants are randomized double-blind to add V940 (mRNA-4157/intismeran autogene), an individualized lipid nanoparticle mRNA neoantigen vaccine encoding up to 34 patient-specific neoantigens to stimulate CD4+/CD8+ T-cell responses, versus placebo.

ClinicalTrials.gov ID: NCT07221474

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.

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 Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer

TrialFetch AI summary: Adults with extensive-stage (or locally advanced non-curable) small cell lung cancer who have completed 4–6 cycles of first-line platinum/etoposide plus atezolizumab or durvalumab and have CR/PR/SD without progression (ECOG 0–2; stable asymptomatic brain metastases allowed) receive maintenance sacituzumab govitecan, a TROP-2–directed antibody–drug conjugate delivering SN-38, combined with ongoing PD-L1 inhibitor maintenance (atezolizumab or durvalumab) until progression/toxicity (up to 2 years).

ClinicalTrials.gov ID: NCT07339059

A Phase 1/2 Study of BMS-986525 as Monotherapy and in Combination With Nivolumab in Participants With Relapsed/Refractory Small Cell Lung Cancer

TrialFetch AI summary: Adults with relapsed/refractory small cell lung cancer after at least one prior platinum-based regimen (and in settings where standard, progressed on/ineligible for/no access to prior anti–PD-(L)1 therapy), excluding untreated CNS metastases and active/suspected autoimmune disease. Participants receive the investigational agent BMS-986525 (mechanism/target not publicly disclosed) as monotherapy or combined with nivolumab (PD-1 inhibitor), with dose-escalation and expansion cohorts assessing safety, PK, and preliminary activity.

ClinicalTrials.gov ID: NCT07325136

Phase II Dose Optimization Study of Platinum/Etoposide Plus Ivonescimab (CEI) as First-Line Treatment of Extensive-Stage Small Cell Lung Cancer

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

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