drugset / Trial / 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.

NCT03863483 ↗

Phase 2 Unknown 70 enrolled Xin-Hua Xu
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2019-03-26
Primary completion
2021-12-31
Completion
2022-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Sintilimab Monoclonal antibody 200 mg Intravenous
Background Docetaxel Small molecule 75 mg/m2 Intravenous
Background Pemetrexed Small molecule 500 mg/m2 Intravenous