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A Study of CS1001 in Subjects With Stage III Non-Small Cell Lung Cancer

NCT03728556 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 381

Last updated 2023-06-15

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, multicenter phase III study to evaluate the efficacy and safety of CS1001 in subjects with locally advanced/unresectable (Stage III) non-small cell lung cancer that has not progressed after prior concurrent/sequential chemoradiotherapy.

Conditions

  • Non-Small Cell Lung Cancer Stage III

Interventions

BIOLOGICAL

CS1001 monoclonal antibody

Participant will receive CS1001 monoclonal antibody 1200 mg by intravenous infusion every 3 weeks, for up to 24 months

BIOLOGICAL

CS1001 placebo

Participant will receive CS1001 placebo by intravenous infusion every 3 weeks, for up to 24 months

Sponsors & Collaborators

Principal Investigators

  • Qing Zhou · Guangdong Provincial People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-26
Primary Completion
2023-04-03
Completion
2023-04-03

Countries

  • China

Study Locations

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Entities

Companies

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 NCT03728556 on ClinicalTrials.gov