At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 397 enrolled
Drug / intervention
Sintilimab +3 moredrug
Likely dose
Sintilimab 10 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Sintilimab, Pemetrexed, and 2 other interventions for Lung Neoplasms. Completed, enrolled 397 participants across 1 site.
Detailed Summary
Efficacy and Safety Evaluation of IBI308 in Patients with advanced or metastatic Non-squamous NSCLC
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Neoplasms
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJul 2018
Enrollment StartAug 2018
Primary CompletionNov 2019
Study CompletionMay 2022
TodayJul 2026
First PostedJul 31, 2018
Enrollment StartAug 23, 2018
Primary CompletionNov 15, 2019
Study CompletionMay 31, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.9 years ago
Interventions
Sintilimabdrug
10 mL:100 mg，200mg，Q3W (qualer 3 weeks), day1, I.V.
Pemetrexeddrug
500mg/m\^2; Q3W (qualer 3 weeks), day1, I.V.
Platinumdrug
Q3W (qualer 3 weeks), day1, I.V.; first 4 cycles.
Placebosdrug
10 mL:100 mg，200mg，Q3W (qualer 3 weeks), day1, I.V.