# OnCo record orient-11 (trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)". Whole corpus: https://onco.cc/api/v1/onco.nt
@prefix schema: <https://schema.org/> .
@prefix onco: <https://onco.cc/ns#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

<https://onco.cc/trials/orient-11/>
  a schema:MedicalTrial ;
  onco:kind "trial" ;
  schema:identifier "orient-11", "NCT03607539" ;
  schema:name "ORIENT-11"@en ;
  schema:description "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."@en ;
  schema:url <https://onco.cc/trials/orient-11/> ;
  schema:dateModified "2026-09-10"^^xsd:date ;
  schema:citation <https://clinicaltrials.gov/study/NCT03607539>, <https://doi.org/10.1016/j.jtho.2020.07.014>, <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> ;
  onco:status "positive" ;
  onco:tag "china" ;
  onco:phase "3" ;
  schema:startDate "2018-08-23" ;
  onco:cancers <https://onco.cc/cancers/nsclc/> ;
  onco:technologies <https://onco.cc/technologies/checkpoint-inhibitor/> ;
  onco:drugs <https://onco.cc/drugs/sintilimab/>, <https://onco.cc/drugs/pemetrexed/> ;
  onco:companies <https://onco.cc/companies/innovent/> ;
  onco:institutions <https://onco.cc/institutions/nmpa-cde/>, <https://onco.cc/institutions/fda-oce/> ;
  onco:keyPapers <https://onco.cc/key-papers/paper-orient-11-j-thorac-oncol-2020/>, <https://onco.cc/key-papers/paper-orient-11-lung-cancer-2022-update/> .