# RAINBOW

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

## TL;DR

Made ramucirumab plus paclitaxel the standard second-line stomach cancer treatment, a role it held for a decade until Enhertu and Claudin drugs arrived.

## Summary

RAINBOW, trial NCT01170663 sponsored by Eli Lilly and reported in Lancet Oncology in 2014, made ramucirumab plus paclitaxel the standard second-line treatment for advanced gastric and gastro-oesophageal junction cancer, a role it held for a decade until trastuzumab deruxtecan and Claudin 18.2 drugs arrived. It randomised 665 patients to ramucirumab or placebo with paclitaxel and met its primary overall survival endpoint, and with REGARD, which tested ramucirumab alone, it established VEGFR2 blockade in gastric cancer. OnCo links it to gastric cancer, VEGF as a target, ramucirumab, paclitaxel and Min-Hee Ryu, and the result is consistent with REGARD and RAINBOW-Asia. It remains the second-line standard for HER2-negative disease and the comparator in DESTINY-Gastric04 and CLARITY-Gastric01, and how long it keeps that role is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT01170663
- Phase: 3
- Setting: Second-line advanced gastric/GEJ cancer: ramucirumab + paclitaxel vs paclitaxel
- Sponsor: Eli Lilly
- Enrolled: 665
- Result: OS 9.6 vs 7.4 months, HR 0.81.
- Outcomes: Overall survival: Ramucirumab + paclitaxel 9.6 months vs Placebo + paclitaxel 7.4 months, HR 0.81
- Replication: Consistent with REGARD (monotherapy OS benefit) and RAINBOW-Asia.

## Sources

- ClinicalTrials.gov NCT01170663: https://clinicaltrials.gov/study/NCT01170663

## Connected records

- cancers: [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/), [PD-L1-high gastric cancer](https://onco.cc/cancers/gastric-pdl1-high/)
- technologies: [Anti-angiogenic therapy](https://onco.cc/technologies/antiangiogenic/), [Monoclonal antibodies](https://onco.cc/technologies/monoclonal-antibody/)
- targets: [VEGF / VEGFR](https://onco.cc/targets/vegf/)
- drugs: [Paclitaxel / nab-paclitaxel](https://onco.cc/drugs/paclitaxel/), [Ramucirumab](https://onco.cc/drugs/ramucirumab/)
- companies: [Eli Lilly (incl. Loxo)](https://onco.cc/companies/eli-lilly/)
- people: [Min-Hee Ryu](https://onco.cc/people/ryu-min-hee/)
- key papers: [RAINBOW: ramucirumab plus paclitaxel versus placebo plus paclitaxel in previously treated advanced gastric cancer](https://onco.cc/key-papers/paper-rainbow-ramucirumab-paclitaxel-lancet-oncol-2014/)

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JSON: https://onco.cc/api/v1/entities/rainbow.json