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COMPLETED
NCT03607539
PHASE3

Efficacy and Safety Evaluation of Sintilimab in Patients With Advanced or Metastatic Non-squamous NSCLC

Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

View on ClinicalTrials.gov

Summary

Efficacy and Safety Evaluation of IBI308 in Patients with advanced or metastatic Non-squamous NSCLC

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

397

Start Date

2018-08-23

Completion Date

2022-05-31

Last Updated

2026-05-11

Healthy Volunteers

No

Conditions

Interventions

DRUG

Sintilimab

10 mL:100 mg,200mg,Q3W (qualer 3 weeks), day1, I.V.

DRUG

Pemetrexed

500mg/m\^2; Q3W (qualer 3 weeks), day1, I.V.

DRUG

Platinum

Q3W (qualer 3 weeks), day1, I.V.; first 4 cycles.

DRUG

Placebos

10 mL:100 mg,200mg,Q3W (qualer 3 weeks), day1, I.V.

Locations (1)

Sun Yat-Sen University Cancer Center

Guangzhou, China