NCT03629925

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

A Randomized, Double-Blind, Phase III Study to Compare the Efficacy and Safety of Sintilimab (IBI308) in Combination With Gemcitabine and Platinum-Based Chemotherapy vs. Placebo in Combination With Gemcitabine and Platinum-Based Chemotherapy as First-Line Treatment for Patients With Advanced or Metastatic Squamous Non-Small-Cell Lung Cancer (NSCLC) (ORIENT-12)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 357 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The anti-tumor activity of anti-PD-1 therapy in previously untreated Chinese squamous NSCLC patients will be investigated in this clinical trial.

Conditions

• Squamous NSCLC

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-09-28
• Primary completion: 2020-03-25
• Completion: 2021-09-30
• First posted: 2018-08-14
• Last updated: 2023-02-28
• Results posted: 2021-04-01

Locations

1 site across 1 country: China