NCT03863483

A Study of Sintilimab or Placebo in Combination With Chemotherapy as Second-line Treatment for Patients With Stage IV Nonsquamous Non-small Cell Lung Cancer With Wild-type EGFR After Failure With Platinum-Containing Chemotherapy.

A Phase II, Prospective, Single-center, Randomized, Controlled Study to Investigate the Efficacy and Safety of Sintilimab or Placebo in Combination With Chemotherapy as Second-line Treatment for Patients With Stage IV Nonsquamous Non-small Cell Lung Cancer With Wild-type EGFR After Failure With Platinum-Containing Chemotherapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Xin-Hua Xu · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This prospective, single-center, randomized, controlled study will evaluate the efficacy and safety of sintilimab or placebo in combination with chemotherapy as second-line treatment for patients with stage IV nonsquamous non-small cell lung cancer with wild-type EGFR after failure with platinum-containing chemotherapy. Treatment may continue as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

Conditions

• Nonsquamous Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Sintilimab	Sintilimab will be administered intravenously at a fixed dose of 200 milligrams (mg) on Day 1 of each 21-day cycle.
DRUG	Docetaxel	Docetaxel 75 milligrams per square meter (mg/m\^2) will be administered intravenously on Day 1 of each 21-day cycle.
DRUG	Pemetrexed	Pemetrexed 500 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle.
DRUG	Placebo	0.9% sodium chloride injection as placebo will be administered intravenously at a fixed dose of 100 milliliters (mL) on Day 1 of each 21-day cycle.

Timeline

• Start date: 2019-03-26
• Primary completion: 2021-12-31
• Completion: 2022-12-31
• First posted: 2019-03-05
• Last updated: 2021-11-08

Locations

1 site across 1 country: China