eligibility_summary
Eligible: consent, ≥18, confirmed LS‑SCLC treated with concurrent chemoRT, no progression (CR/PR/SD), ECOG 0–1, ≥12‑wk life expectancy, adequate organs, toxicities ≤grade 1 (except alopecia/fatigue). Exclude: ES‑SCLC, transformed/mixed NSCLC, ILD/pneumonitis, recent other cancer, transplant, MI/CHF, stroke/TIA, HIV/hepatitis per protocol, acute infection, sequential chemoRT, prior DLL3 inhibitor, severe immune AEs, other therapy, recent steroids/surgery/vaccines/trial, pregnancy/lactation, contraception noncompliance, allergy, likely nonadherence.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Tarlatamab (AMG 757), an intravenous, half-life–extended bispecific T‑cell engager (BiTE) antibody construct, comparator: placebo. Mechanism of action: Tarlatamab binds Delta-like ligand 3 (DLL3) on small-cell lung cancer (SCLC) cells and CD3 on T cells, redirecting and activating cytotoxic T lymphocytes to kill DLL3+ tumor cells via TCR/CD3 signaling, immune synapse formation, perforin/granzyme release, and cytokine-mediated cytotoxicity. Target cells/pathways: DLL3-expressing SCLC tumor cells (DLL3 is an inhibitory Notch ligand overexpressed in SCLC, minimal in normal tissue) and CD3+ T cells (primarily CD8+ effectors). Setting: maintenance after concurrent chemoradiation in limited-stage SCLC, primary aim is to improve PFS and OS in a randomized, double-blind phase 3 study.