MedTrace Logo

Sintilimab in Combination With Gemcitabine and Platinum-Based Chemotherapy as First-Line Therapy for Advanced or Metastatic Squamous NSCLC

NCT03629925 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 357

Last updated 2023-02-28

Study results available
· View outcomes & findings →

Summary

Efficacy and Safety Evaluation of IBI308 in Patients with Advanced or Recurrent Squamous NSCLC

Conditions

  • Squamous NSCLC

Interventions

DRUG

Sintilimab

200mg, Q3W, day1, I.V.; consecutive cycles

DRUG

Gemcitabine

1000mg/m\^2, Q3W, day 1and 8, I.V.; first 4 or 6 consecutive cycles.

DRUG

Cisplatin

75 mg/m\^2, Q3W, day1, I.V.; first 4 or 6 consecutive cycles.

DRUG

Placebo

NA, Q3W, day1, I.V.; consecutive cycles

DRUG

Carboplatin

AUC 5mg/ml/min, Q3W, day1, I.V.; first 4 or 6 consecutive cycles.

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Caicun Zhou · Shanghai Pulmonary Hospital, Shanghai, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-09-28
Primary Completion
2020-03-25
Completion
2021-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT03629925 on ClinicalTrials.gov