At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 357 enrolled
Drug / intervention
Sintilimab +4 moredrug
Likely dose
Sintilimab 200mgfrom 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-Blind, Phase III Study to Compare the Efficacy and Safety of Sintilimab (IBI308) in Combination With Gemcitabine and Platinum-Based Chemotherapy vs. Placebo in Combination With Gemcitabine and Platinum-Based Chemotherapy as First-Line Treatment for Patients With Advanced or Metastatic Squamous Non-Small-Cell Lung Cancer (NSCLC) (ORIENT-12)
In Brief
A Phase 3 clinical trial evaluating Sintilimab, Gemcitabine, and 3 other interventions for Squamous NSCLC. Completed, enrolled 357 participants across 1 site.
Detailed Summary
Efficacy and Safety Evaluation of IBI308 in Patients with Advanced or Recurrent Squamous NSCLC
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSquamous NSCLC
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedAug 2018
Enrollment StartSep 2018
Primary CompletionMar 2020
Study CompletionSep 2021
TodayJul 2026
First PostedAug 14, 2018
Enrollment StartSep 28, 2018
Primary CompletionMar 25, 2020
Study CompletionSep 30, 2021
TodayJul 1, 2026
Enrollment to primary: 1.5 yearsPosted 7.9 years ago
Interventions
Sintilimabdrug
200mg, Q3W, day1, I.V.; consecutive cycles
Gemcitabinedrug
1000mg/m\^2, Q3W, day 1and 8, I.V.; first 4 or 6 consecutive cycles.
Cisplatindrug
75 mg/m\^2, Q3W, day1, I.V.; first 4 or 6 consecutive cycles.
Placebodrug
NA, Q3W, day1, I.V.; consecutive cycles
Carboplatindrug
AUC 5mg/ml/min, Q3W, day1, I.V.; first 4 or 6 consecutive cycles.