Tarlatamab — 2L+ extensive-stage SCLC (DeLLphi-301; DLL3 × CD3 BiTE)
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
Knowledge-base record for audit. Provisional clinical content: this is not a prescription. An oncologist must verify original sources, applicability and review status. Full rules and constraints are in the YAML.
| Components | DRUG-TARLATAMAB |
|---|
| ID | REG-TARLATAMAB |
|---|---|
| Type | Regimen |
| Status | reviewed 2026-05-08 | pending_clinical_signoff |
| Diseases | None declared |
| Sources | SRC-DELLPHI-301-AHN-2023 SRC-ESMO-SCLC-2021 SRC-NCCN-SCLC-2025 |
Notes
DeLLphi-301 (Ahn et al., NEJM 2023; NCT05060016): open-label multicenter phase 2 trial of tarlatamab (DLL3 × CD3 bispecific T-cell engager) in pretreated extensive-stage SCLC progressing on or after platinum-based chemotherapy. 222 patients randomized 1:1 to 10 mg q2w vs 100 mg q2w. 10 mg q2w cohort (n=99) — confirmed ORR per independent central review 40% (95% CI 29-52); mDoR not reached at 10.6 mo follow-up; mPFS 4.9 mo; mOS 14.3 mo (95% CI 10.8-NE). 100 mg cohort showed similar ORR with higher CRS rate; 10 mg selected as registered dose. CRS any-grade ~50% (mostly cycle 1 D1-D2 fever ± mild hypotension); Grade ≥3 CRS ~1%. ICANS-like neurotoxicity Grade ≥3 ~7%. Step-up dosing (1 mg → 10 mg) + inpatient cycle 1 D1 + D8 monitoring (22+ hr) is mandatory per US prescribing information; mitigates CRS through immune-effector priming. Tocilizumab + corticosteroids first-line for Grade ≥2 CRS / ICANS. FDA accelerated approval May 2024. NCCN-SCLC 2025 category 2A for ES-SCLC 2L+ post-platinum. Confirmatory phase 3 DeLLphi-304 (tarlatamab vs investigator-choice chemotherapy in 2L ES-SCLC) ongoing. Active development: maintenance post-1L chemo-IO (DeLLphi-303); SCLC-transformed NSCLC; neur...
Used By
Indication
IND-SCLC-RR-TARLATAMAB- IND-SCLC-RR-TARLATAMAB