eligibility_summary
Eligible: adults (≥18) with hist/cyt ES‑SCLC (AJCC IV or extensive T3–T4) who completed 3–4 cycles platinum/etoposide + durvalumab 1L without progression, ECOG 0–1, >12‑wk life expectancy, adequate organ function, prior LS‑SCLC ok if >6 mo, prior tox ≤G1. Exclude: active CNS/leptomeningeal mets (treated allowed), severe immune AEs/autoimmune dz, recent MI/CHF/stroke, ILD/pneumonitis, transplant, major surgery <28 d, infection/immunosuppression/live vaccine, other cancer <2 y, other therapy, prior DLL3, planned chest RT, pregnancy/lactation, hypersensitivity, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3, randomized, open-label maintenance study in first-line ES-SCLC after platinum/etoposide+durvalumab, comparing tarlatamab+durvalumab vs durvalumab alone, primary endpoint: overall survival. Interventions and mechanisms: • Tarlatamab (AMG 757): an IV half-life–extended bispecific T‑cell engager (BiTE) that binds DLL3 on SCLC cells and CD3 on T cells, redirecting cytotoxic T‑cell killing of DLL3+ tumor cells. • Durvalumab: an IV anti–PD-L1 monoclonal antibody checkpoint inhibitor that blocks PD‑L1 interactions with PD‑1/CD80, restoring T‑cell activity. Targets/pathways: DLL3 on neuroendocrine SCLC, CD3/TCR-driven T‑cell activation, PD‑1/PD‑L1 immune checkpoint axis. Rationale: pair tumor-directed T‑cell engagement with checkpoint blockade to enhance and sustain antitumor immunity.