A Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Trial of CS1001 as Consolidation Treatment in Subjects With Locally Advanced/Unresectable (Stage III) Non-Small Cell Lung Cancer That Has Not Progressed After Prior Concurrent/Sequential Chemoradiotherapy

CStone Pharmaceuticals1 site in 1 country381 target enrollmentOctober 26, 2018

ConditionsNon-Small Cell Lung Cancer Stage III

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Non-Small Cell Lung Cancer Stage III
Sponsor: CStone Pharmaceuticals
Enrollment: 381
Locations: 1
Primary Endpoint: Progress Free Survival (PFS)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 26, 2018

End Date

April 3, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

CStone Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Willing to participate in this trial; fully understand and informed of this trial, and able to provide written informed consent form (ICF).
•≥ 18 years of age on the day of signing ICF.
•Have histologically confirmed locally advanced/unresectable stage III non-small cell lung cancer.
•The first dose of CS1001 will be administered within 1 - 42 days (including 42 days) after concurrent/sequential chemoradiotherapy is completed.
•Platinum-containing chemotherapy.
•Absence of progression after concurrent/sequential chemoradiotherapy.
•Eastern Cooperative Oncology Group(ECOG) Perfomance Status (PS) of 0 or
•Life expectancy ≥ 12 weeks.
•Subject with prior anti-cancer treatment can only be enrolled when all toxicities except for hearing loss, alopecia and fatigue, of prior anti-cancer treatment has recovered to baseline or ≤ Grade 1 (according to National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] v4.03).
•Subjects must have adequate organ function as assessed in the following laboratory tests.

Exclusion Criteria

•Histologically identified to have mixed small cell lung cancer component.
•Disease progression after concurrent/sequential chemoradiotherapy.
•Major surgical procedure (as determined by investigators) within 28 days prior to the first dose of investigational product.
•Has received a live vaccine within 28 days prior to the first dose of investigational product.
•Current participation in another clinical study or use of any investigational drug within 28 days prior to the first dose of investigational product in this trial. (Participation in the overall survival follow-up of a study is allowed.)
•Any prior treatment of antibody/drug that targets at T-cell coregulatory proteins (immune checkpoints, including PD-1, PD-L1, CTLA4, TIM3 and LAG3, etc.).
•Subjects with current active autoimmune disease or prior history of autoimmune disease that probably will relapse or at risk of having these conditions.
•Immune deficient disease or systemic corticosteroid treatment within 7 days prior to the first dose of investigational product, or any other form of immune suppressing treatment.
•A known additional malignancy within 5 years prior to the first dose of investigational product.
•History of inflammatory bowel disease or active inflammatory bowel disease (for example Crohn's disease or ulcerative colitis).

Outcomes

Primary Outcomes

Progress Free Survival (PFS)

Time Frame: from the date of randomization to the first date of recorded progression or all-cause death, whichever comes first, assessed up to 30 months.

The primary endpoint is the PFS of CS1001 versus placebo (evaluated by blinded independent central review(BICR) according to response evaluation criteria in solid tumors RECIST v1.1).