# ORIENT-11

Source: https://onco.cc/trials/orient-11/  
OnCo record `orient-11` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The trial that made sintilimab a first-line lung cancer treatment in China, and the one the FDA later refused to accept as evidence for US patients.

## Summary

397 patients randomised 2:1. Median progression-free survival 8.9 versus 5.0 months (hazard ratio 0.482) at the interim analysis, with benefit across PD-L1 subgroups; overall survival later favoured sintilimab. NMPA approval followed in February 2021. Innovent and Lilly filed the same data with the FDA; at a February 2022 advisory committee members voted 14 to 1 that a single-country trial with a chemotherapy-alone comparator did not show applicability to US patients, and a complete response letter followed in March 2022, setting the template for how China-only trials are judged.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-10
- Tags: china
- Registry id: NCT03607539
- Phase: 3
- Setting: First-line non-squamous NSCLC without EGFR or ALK alterations, China: sintilimab or placebo plus pemetrexed and platinum
- Sponsor: Innovent Biologics
- Enrolled: 397
- Result: PFS 8.9 vs 5.0 months, HR 0.482.
- Outcomes: Progression-free survival: Sintilimab + pemetrexed-platinum 8.9 months vs Placebo + pemetrexed-platinum 5 months, HR 0.482

## Sources

- ClinicalTrials.gov NCT03607539: https://clinicaltrials.gov/study/NCT03607539
- J Thorac Oncol 2020: https://doi.org/10.1016/j.jtho.2020.07.014
- FDA ODAC 10 February 2022 (archived copy): https://web.archive.org/web/20250302091714/https://www.fda.gov/advisory-committees/advisory-committee-calendar/february-10-2022-meeting-oncologic-drugs-advisory-committee-meeting-announcement-02102022

## Connected records

- cancers: [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Pemetrexed](https://onco.cc/drugs/pemetrexed/), [Sintilimab](https://onco.cc/drugs/sintilimab/)
- companies: [Innovent Biologics](https://onco.cc/companies/innovent/)
- institutions: [FDA Oncology Center of Excellence](https://onco.cc/institutions/fda-oce/), [National Medical Products Administration / Center for Drug Evaluation](https://onco.cc/institutions/nmpa-cde/)
- key papers: [Efficacy and Safety of Sintilimab Plus Pemetrexed and Platinum as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC: a Randomized, Double-Blind, Phase 3 Study (Oncology pRogram by InnovENT anti-PD-1-11)](https://onco.cc/key-papers/paper-orient-11-j-thorac-oncol-2020/), [Final overall survival data of sintilimab plus pemetrexed and platinum as First-Line treatment for locally advanced or metastatic nonsquamous NSCLC in the Phase 3 ORIENT-11 study](https://onco.cc/key-papers/paper-orient-11-lung-cancer-2022-update/)
- roadmaps: [Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation](https://onco.cc/roadmaps/global-access-roadmap/)

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