ORIENT-31
Sintilimab ± IBI305 Plus Chemotherapy (Pemetrexed + Cisplatin) for EGFRm + Locally Advanced or Metastasis Non-Squamous NSCLC Patients After EGFR-TKI Treatment Failure
- NCT03802240 ↗
- Completed
- Innovent Biologics (Suzhou) Co. Ltd.
- Deep size, estimated: 301+ verified statements
We haven't built an HCP commentary report on ORIENT-31 (sintilimab plus IBI305; sintilimab in EGFR-mutated non-squamous NSCLC after EGFR-TKI treatment failure) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on ORIENT-31 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Indexed so far | |
|---|---|
| 26 posts on X | |
| 13 podcast episodes | |
| 7 YouTube videos |
The trial
ClinicalTrials.gov- Official title
- A Randomized, Double-blind, Multi-center, Phase III Clinical Study Assessing the Efficacy and Safety of Sintilimab ± IBI305 Combined With Pemetrexed and Cisplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Who Have Failed Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Treatment (ORIENT-31)
- Phase
- Phase 3
- Status
- Completed
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Interventions
- Sintilimab; IBI305; Pemetrexed; Cisplatin; Placebo1; Placebo2
- Arms
- Sintilimab +IBI305+Pemetrexed+Cisplatin · Experimental
- Sintilimab +Placebo2+Pemetrexed+Cisplatin · Experimental
- Placebo1+Placebo2+Pemetrexed+Cisplatin · Active comparator
- Enrollment
- 492
- Primary outcomes
- PFS (Progression Free Survival)
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Start
- Jul 11, 2019
- Primary completion
- Jul 31, 2021
- Results posted
- No
- Registry record
- NCT03802240 · updated Nov 27, 2023
Publications
linked from the registry- Lu S, Wu L, Jian H, Cheng Y, Wang Q, Fang J, Wang Z, Hu Y, Han L, Sun M, Miao L, Ding C, Cui J, Wang K, Li B, Li X, Ye F, Liu A, Pan Y, Cang S, Zhou H, Sun X, Shen Y, Wang S, Zhang W, He Y. Sintilimab plus chemotherapy for patients with EGFR-mutated non-squamous non-small-cell lung cancer with disease progression after EGFR tyrosine-kinase inhibitor therapy (ORIENT-31): second interim analysis from a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Respir Med. 2023 Jul;11(7):624-636. doi: 10.1016/S2213-2600(23)00135-2. Epub 2023 May 5. PubMed 37156249
- Lu S, Wu L, Jian H, Chen Y, Wang Q, Fang J, Wang Z, Hu Y, Sun M, Han L, Miao L, Ding C, Cui J, Li B, Pan Y, Li X, Ye F, Liu A, Wang K, Cang S, Zhou H, Sun X, Ferry D, Lin Y, Wang S, Zhang W, Zhang C. Sintilimab plus bevacizumab biosimilar IBI305 and chemotherapy for patients with EGFR-mutated non-squamous non-small-cell lung cancer who progressed on EGFR tyrosine-kinase inhibitor therapy (ORIENT-31): first interim results from a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2022 Sep;23(9):1167-1179. doi: 10.1016/S1470-2045(22)00382-5. Epub 2022 Jul 28. PubMed 35908558