Tarlatamab — SCLC à phase étendue 2L+ (DeLLphi-301; DLL3 × CD3 BiTE)
Vue déterministe de l'entité source de la LJAM. L'autorité clinique demeure avec les ID de la source cités et l'état d'approbation de l ́examinateur.
Contenu clinique provisoire : il ne s'agit pas d'une ordonnance. Un oncologue doit vérifier les sources originales, l'applicabilité et le statut de révision.
| Composantes | DRUG-TARLATAMAB |
|---|
| ID | REG-TARLATAMAB |
|---|---|
| Type | Protocole thérapeutique |
| État | reviewed 2026-05-08 | pending_clinical_signoff |
| Maladies | Aucune déclaration |
| 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...
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Indication
IND-SCLC-RR-TARLATAMAB- IND-SCLC-RR-TARLATAMAB