Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT03789604

PHASE3

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

Sponsor: 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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

479

Start Date

2018-12-13

Completion Date

2027-06-30

Last Updated

2025-07-24

Healthy Volunteers

Conditions

Non Small Cell Lung Cancer

Interventions

BIOLOGICAL

CS1001 monoclonal antibody

Participant will receive CS1001 monoclonal antibody 1200 mg by intravenous infusion every 3 weeks, for up to 24 months; Drug Carboplatin on Day 1 of each 21-day cycle; Drug Pemetrexed on Day 1 of each 21-day cycle; Drug Paclitaxel on Day 1 of each 21-day cycle

BIOLOGICAL

CS1001 placebo

Participant will receive CS1001 placebo 1200 mg by intravenous infusion every 3 weeks, for up to 24 months; Drug Carboplatin on Day 1 of each 21-day cycle; Drug Pemetrexed on Day 1 of each 21-day cycle; Drug Paclitaxel on Day 1 of each 21-day cycle

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