CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 290 enrolled
Drug / intervention
IBI308 +1 moredrug
Likely dose
Not stated in 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.

Search/NCT03150875
NCT03150875Phase 3Completed
CompareCT.gov

Efficacy and Safety Evaluation of IBI308 Versus Docetaxel in Patients With Advanced or Metastatic Squamous Cell Lung Cancer After Failure of First-line Platinum-based Therapy- a Randomized, Open-label, Multicenter, Parallel, Phase 3 Study (ORIENT-3)

Innovent Biologics (Suzhou) Co. Ltd.·interventional·Posted May 12, 2017·Updated Feb 28, 2023

In Brief

A Phase 3 clinical trial evaluating IBI308 and Docetaxel for Non-small Cell Lung Cancer. Completed, enrolled 290 participants across 2 sites.

Detailed Summary

Clinical trial results demonstrate that anti-PD-1 antibodies prolonged OS to approximately 9 months compared with 6 months in docetaxel group. Anti-PD-1 therapy in Chinese squamous NSCLC patients will be investigated in this clinical trial. Additionally, the correlation between PD-L1 expression and the response to IBI308 treatment in Chinese squamous cell NSCLC patients as well as the role of irRECIST in immune checkpoint inhibitor treatment evaluation will also be assessed

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-small Cell Lung Cancer
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMay 12, 2017
Enrollment StartSep 1, 2017
Primary CompletionFeb 22, 2023
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 9.1 years ago

Interventions

IBI308drug

Anti-PD-1 therapy in Chinese squamous NSCLC patients will be investigated in this clinical trial.

Docetaxeldrug

As 2nd line treatment to subjects with squamous NSCLC