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A Study of CS1001 in Subjects With Stage IV Non-Small Cell Lung Cancer | Clinical Trials | Clareo Health

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

A Multi-Center, Randomized, Double-Blind, Phase III Study of Platinum-Containing Chemotherapy With or Without CS1001 in Stage IV Non-Small Cell Lung Cancer Subjects

NCT03789604•CStone Pharmaceuticals

View on ClinicalTrials.gov

Summary

This is a multi-center, randomized, double-blind, phase III study to evaluate the efficacy and safety of CS1001 in combination with platinum-containing chemotherapy versus placebo in combination with chemotherapy in first-line treatment-naive subjects with stage IV non-small cell lung cancer (NSCLC).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Willing to participate in this trial; fully understand and informed of this trial, and able to provide written informed consent form (ICF).
•2. 18-75 years of age (18 and 75 included) on the day of signing ICF.
•3. Histologically or cytologically confirmed stage IV non-small cell lung cancer (staged according to the 8th International Association for the Study of Lung Cancer (IASLC) classification.
•4. Subjects haven't received systemic treatment for advanced/metastatic NSCLC.
•5. Measurable target lesion evaluated by investigators according to RECIST v1.1.
•6. ECOG PS of 0-1.
•7. Life expectancy ≥ 12 weeks.
•8. 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 ≤ Grade 1 according to National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
•9. Subjects must have adequate organ function.
•10. Women of childbearing potential (WOBPC, as defined in section 13.5) must have a negative pregnancy test ≤7 days prior to the first dose of investigational product. WOBCP or fertile men and their WOBCP partners must agree to use an effective method of birth control from providing signed ICF and for 6 months after last dose of investigational product.

Exclusion Criteria

•1. Histologically confirmed small cell lung cancer or containing small cell component.
•2. Subjects with current active autoimmune disease or prior history of autoimmune disease.
•3. Malignancies other than NSCLC within 5 years prior to randomization.
•4. Known history of human immunodefiency virus (HIV) infection and/or acquired immune deficiency syndrome.
•5. Subject with active hepatitis B or hepatitis C.
•6. Subjects with known history of alcoholism or drugs abuse.
•7. Has a known hypersensitivity to any component of study treatment, for example pemetrexed, cisplatin, carboplatin or other platinum compounds.
•8. Subjects with other conditions that in the investigator's opinion may influence subject's compliance or make subjects not suitable for participating in this trial.

Locations (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

December 13, 2018

Primary Completion Date

May 15, 2023

Completion Date

June 30, 2027

Last Updated

July 24, 2025

Enrollment

479

ACTUAL participants

Conditions

Non Small Cell Lung Cancer

Interventions

CS1001 monoclonal antibody

BIOLOGICAL

CS1001 placebo

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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