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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 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-11-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Xin-Hua Xu

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

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

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 NCT03863483 on ClinicalTrials.gov