eligibility_summary
Eligible: Adults (≥18) with ES‑SCLC progressed/recurred after ≥1 platinum regimen (if prior LS‑SCLC, also treated for recurrent ES‑SCLC), ECOG 0–1, adequate organ function, able to receive abdominal SC injections, measurable disease or tumor tissue preferred but may be waived with sponsor approval. Exclude: prior DLL3 therapy, symptomatic or steroid‑requiring brain mets, untreated brain mets unless asymptomatic and monitor‑approved, leptomeningeal disease, baseline O2 need.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1b study of subcutaneous tarlatamab (AMG 757, Imdelltra), a half-life–extended bispecific T‑cell engager (BiTE) antibody construct (immunotherapy). Mechanism: simultaneously binds DLL3 on tumor cells and CD3 on T cells to redirect cytotoxic T cells, forming an immune synapse that triggers perforin/granzyme-mediated lysis and cytokine release. Targets: Delta-like ligand 3 (DLL3), an atypical Notch-pathway ligand highly expressed on SCLC/neuroendocrine tumor cells with minimal normal tissue expression, engages CD3+ T lymphocytes. The trial explores SC dosing (dose exploration/expansion/alternative) in ES-SCLC post-platinum, assessing safety, tolerability, PK, and preliminary antitumor activity.