eligibility_summary
Inclusion: Chinese residents of Chinese ancestry ≥18 with histologically confirmed extensive-stage SCLC, progressed after platinum 1L (incl PD‑1/L1) plus ≥1 other line, measurable disease (RECIST 1.1), ECOG 0–1, life expectancy ≥12 weeks, adequate organs. Exclusion: transformed NSCLC, symptomatic CNS/leptomeningeal disease, severe prior irAEs, active autoimmune/ILD/pneumonitis/infection, recent MI/CHF/stroke/surgery, other cancer, HIV/HBV/HCV (exceptions), recent anticancer/immunosuppression/vaccines, prior DLL3/tarlatamab, other trials, pregnancy/no contraception, hypersensitivity, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2a, single-arm study in China evaluating tarlatamab (AMG 757, IMDELLTRA), an intravenous bispecific T-cell engager (BiTE) for advanced/extensive-stage SCLC after ≥2 prior lines. Mechanism: simultaneously binds DLL3 on SCLC tumor cells and CD3 on endogenous T cells, creating an immune synapse that activates TCR/CD3 signaling and redirects T-cell cytotoxicity against DLL3-expressing cells. Targets: DLL3-positive neuroendocrine SCLC cells (Notch/DLL3 pathway) and CD3+ T lymphocytes. Primary endpoint: ORR by BICR (RECIST 1.1).