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

NCT03607539 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 397

Last updated 2026-05-11

Study results available
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Summary

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

Conditions

  • Lung Neoplasms

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.

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Li Zhang, Doctor · SunYat-senUniversity

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-23
Primary Completion
2019-11-15
Completion
2022-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03607539 on ClinicalTrials.gov