Status:
ACTIVE_NOT_RECRUITING
A Study of CS1001 in Subjects With Stage IV Non-Small Cell Lung Cancer
Lead Sponsor:
CStone Pharmaceuticals
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- Willing to participate in this trial; fully understand and informed of this trial, and able to provide written informed consent form (ICF).
- 18-75 years of age (18 and 75 included) on the day of signing ICF.
- 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.
- Subjects haven't received systemic treatment for advanced/metastatic NSCLC.
- Measurable target lesion evaluated by investigators according to RECIST v1.1.
- ECOG PS of 0-1.
- 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 ≤ Grade 1 according to National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
- Subjects must have adequate organ function.
- 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
- Histologically confirmed small cell lung cancer or containing small cell component.
- Subjects with current active autoimmune disease or prior history of autoimmune disease.
- Malignancies other than NSCLC within 5 years prior to randomization.
- Known history of human immunodefiency virus (HIV) infection and/or acquired immune deficiency syndrome.
- Subject with active hepatitis B or hepatitis C.
- Subjects with known history of alcoholism or drugs abuse.
- Has a known hypersensitivity to any component of study treatment, for example pemetrexed, cisplatin, carboplatin or other platinum compounds.
- 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.
Key Trial Info
Start Date :
December 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2027
Estimated Enrollment :
479 Patients enrolled
Trial Details
Trial ID
NCT03789604
Start Date
December 13 2018
End Date
June 30 2027
Last Update
July 24 2025
Active Locations (1)
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1
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China