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

PHASE3CompletedINTERVENTIONAL
Enrollment

357

Participants

Timeline

Start Date

September 28, 2018

Primary Completion Date

March 25, 2020

Study Completion Date

September 30, 2021

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.

Trial Locations (1)

200433

Shanghai Pulmonary Hospital, Shanghai

All Listed Sponsors
lead

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

NCT03629925 - Sintilimab in Combination With Gemcitabine and Platinum-Based Chemotherapy as First-Line Therapy for Advanced or Metastatic Squamous NSCLC | Biotech Hunter | Biotech Hunter