Practice-entering research
SPOTLIGHT — zolbetuximab + mFOLFOX6 in CLDN18.2+ gastric adenocarcinoma
A Phase 3 Study of Zolbetuximab Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin 18.2-Positive, HER2-Negative Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (SPOTLIGHT)
- Phase
- Phase III
- Recruitment
- Active, not recruiting
- Results maturity
- Final analysis
- Publication
- Peer-reviewed
- Regulatory approval
- FDA approval (US)
- NCT
- NCT03504397
- Registry checked
- 2026-10-29
- Editorial update
- 2026-10-29
Not a treatment recommendation. Experimental or ongoing research does not by itself replace standard care.
For patients
What is being studied? If the CLDN18.2 target is positive in stomach cancer, a special antibody drug may be added to chemotherapy. Testing is required.
Why promising? CLDN18.2-targeted mAb + chemotherapy showed first-line PFS benefit.
What is not proven? Benefit in CLDN18.2− disease; simultaneous access/standard in every region.
Is this standard care today? This listing alone does not replace standard care; approval and guideline context require clinician judgment.
For clinicians
Lancet 2023 SPOTLIGHT; GLOW is separate. This card is NCT03504397 / SPOTLIGHT only.
Cancer / population: Gastric / esophageal — CLDN18.2+ HER2− lokal ileri / metastatik mide veya GEJ
Intervention: Zolbetuximab + mFOLFOX6
Primary endpoint: PFS
Limitations: Biyobelirteç seçimi zorunlu; bulantı/kusma yönetimi kritik.
Landmark Atlas links
Cross-links are informational only; this module does not award or change gold stars.