# SPOTLIGHT & GLOW

Source: https://onco.cc/trials/spotlight-glow/  
OnCo record `spotlight-glow` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Two trials that made Claudin 18.2 the third biomarker in stomach cancer, adding about two to three months of survival with an antibody against it.

## Summary

SPOTLIGHT: PFS 10.6 vs 8.7 months, OS 18.2 vs 15.5 months. GLOW: PFS 8.2 vs 6.8, OS 14.4 vs 12.2 months. About 38% of screened patients were CLDN18.2-positive at the ≥75% threshold. FDA approval 18 October 2024 (Vyloy), first CLDN18.2-directed therapy. Nausea and vomiting, on-target from gastric mucosa, are frequent and front-loaded.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Also known as: SPOTLIGHT; GLOW; spotlight-glow
- Registry id: NCT03504397
- Phase: 3
- Setting: First-line CLDN18.2-positive (≥75% of cells), HER2-negative advanced gastric/GEJ adenocarcinoma: zolbetuximab + mFOLFOX6 (SPOTLIGHT) or CAPOX (GLOW) vs chemotherapy
- Sponsor: Astellas
- Result: SPOTLIGHT OS 18.2 vs 15.5 months; GLOW OS 14.4 vs 12.2 months.
- Outcomes: Overall survival (SPOTLIGHT): Zolbetuximab + mFOLFOX6 18.2 months vs Placebo + mFOLFOX6 15.5 months; Overall survival (GLOW): Zolbetuximab + CAPOX 14.4 months vs Placebo + CAPOX 12.2 months
- Replication: Two independent phase 3 trials with different chemotherapy backbones agree.

## Sources

- ClinicalTrials.gov NCT03504397: https://clinicaltrials.gov/study/NCT03504397
- GLOW NCT03653507: https://clinicaltrials.gov/study/NCT03653507

## Connected records

- cancers: [Claudin 18.2-positive gastric cancer](https://onco.cc/cancers/gastric-cldn18-2-positive/), [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/)
- technologies: [Monoclonal antibodies](https://onco.cc/technologies/monoclonal-antibody/)
- targets: [Claudin 18.2](https://onco.cc/targets/cldn18-2/)
- drugs: [Capecitabine](https://onco.cc/drugs/capecitabine/), [CAPOX (capecitabine, oxaliplatin)](https://onco.cc/drugs/capox/), [FOLFOX (5-FU, leucovorin, oxaliplatin)](https://onco.cc/drugs/folfox/), [Oxaliplatin](https://onco.cc/drugs/oxaliplatin/), [Zolbetuximab](https://onco.cc/drugs/zolbetuximab/)
- companies: [Astellas](https://onco.cc/companies/astellas/)
- people: [Kohei Shitara](https://onco.cc/people/shitara-kohei/), [Min-Hee Ryu](https://onco.cc/people/ryu-min-hee/), [Sun Young Rha](https://onco.cc/people/rha-sun-young/), [Yoon-Koo Kang](https://onco.cc/people/kang-yoon-koo/)
- pairings: [CLDN18.2 antibody first line → CLDN18.2 ADC or CAR-T on progression](https://onco.cc/pairings/cldn18-antibody-then-adc/)
- ideas: [Biomarker-directed first-line quadruplets in gastric cancer](https://onco.cc/ideas/idea-biomarker-quadruplet-gastric/)

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