ArticleFrontiers in oncology2022
The Applicability of the Results in the Asian Population of ORIENT-11 to a Western Population According to the ICH-E5 Framework.
Article in Frontiers in oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03607539 (A Randomized, Double-blinded, Phase III Study of Pemetrexed Plus Platinum Chemotherapy With or Without Sintilimab), which is not on this map. Cited by 4 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-blinded, Phase III Study of Pemetrexed Plus Platinum Chemotherapy With or Without Sintilimab (IBI308) in First Line Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Subjects (Orient-11)
Who cites it
4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 4 citations in OpenAlex.
- Efficacy and safety of antibody-drug conjugates in pretreated HER2-positive advanced breast cancer: a network meta-analysis of randomized controlled trials.Frontiers in pharmacology · 2026Pooled it
- Efficacy and safety of antibody-drug conjugate based therapy in locally advanced or metastatic urothelial carcinoma: a systematic review and network meta-analysis of emerging clinical evidence.Frontiers in immunology · 2026Pooled it
- Exposure-response relationship of sintilimab in advanced gastric cancer: insights from time-dependent pharmacokinetics and biomarker integration for precision immunotherapy.Frontiers in pharmacology · 2026Review
- Pembrolizumab versus sintilimab in patients with advanced NSCLC: a retrospective multicenter study with propensity-score matching analysis.Frontiers in oncology · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Sintilimab combined with pemetrexed and platinum met the primary endpoint of improving progression-free survival (PFS) as a first-line therapy for nonsquamous non-small cell lung cancer (NSCLC) in the phase 3 trial ORIENT-11 (NCT03607539). As seen in similar trials, the addition of sintilimab, a PD-1 inhibitor, to chemotherapy improved the PFS without significantly worsening the toxicity, with improvements in response rate and duration of response. In contrast to previous trials, the ORIENT-11 trial was conducted completely in China. Both intrinsic and extrinsic factors are important to consider when reviewing foreign clinical trial data, as they may influence the efficacy and the safety outcomes. Here we discuss the applicability of ORIENT-11 clinical results to a Western population.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.