Zolbetuximab + mFOLFOX6 (SPOTLIGHT) — 1L CLDN18.2-positive HER2-negative gastric/GEJ

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.

Source YAML: complete record

Components	`DRUG-ZOLBETUXIMAB` `DRUG-OXALIPLATIN` `DRUG-LEUCOVORIN` `DRUG-5-FLUOROURACIL`

ID	`REG-ZOLBETUXIMAB-CHEMO`
Type	Regimen
Status	reviewed 2026-04-30 \| pending_clinical_signoff
Diseases	None declared
Sources	`SRC-ESMO-GASTRIC-2024` `SRC-NCCN-GASTRIC-2025`

Notes

SPOTLIGHT (Shitara Lancet 2023) registrational: zolbetuximab + mFOLFOX6 vs mFOLFOX6 in CLDN18.2+ (≥75% 2+/3+) HER2- 1L metastatic gastric/GEJ — mPFS 10.6 vs 8.7 mo (HR 0.75); mOS 18.2 vs 15.5 mo (HR 0.75). GLOW (Shah Nat Med 2023) parallel CAPOX backbone — consistent benefit (mOS 14.4 vs 12.2 mo). FDA approval Oct 2024. Cycle-1 nausea/vomiting is the principal tolerability challenge — triple-antiemetic prophylaxis + slow infusion mandatory; tolerance improves cycles 2+. Hierarchy when multiple actionable signals co-occur: HER2+ trastuzumab supersedes; MSI-H pembrolizumab supersedes; otherwise CLDN18.2+ → zolbetuximab. STUB pending Clinical Co-Lead sign-off; bibliographic record SRC-SPOTLIGHT-SHITARA-2023 and SRC-GLOW are available; clinical claim linkage requires dual clinical sign-off.

Used By

Indication

IND-GASTRIC-METASTATIC-1L-CLDN18-2-ZOLBETUXIMAB - IND-GASTRIC-METASTATIC-1L-CLDN18-2-ZOLBETUXIMAB