Clinical trial NCT03789604: A Study of CS1001 in Subjects With Stage IV Non-Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Non Small Cell Lung Cancer
Lead sponsor: CStone Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2018-12-28
Enrollment: 479
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 chemotherapy in first-line treatment-naive subjects with stage IV non-small cell lung cancer (NSCLC).


Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free survival (PFS) in all subjects evaluated by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
timeFrame: up to approximately 5 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: up to approximately 7 years
measure: PFS assessed by BICR
timeFrame: up to approximately 5 years
measure: PFS in subgroup of participants with PD-L1 Expression≥1%, as determined by the investigator
timeFrame: up to approximately 5 years
measure: Objective Response Rate (ORR) assessed by the investigator according to RECIST v1.1
timeFrame: up to approximately 5 years
measure: Duration of response (DOR) assessed by the investigator according to RECIST v1.1
timeFrame: up to approximately 5 years
measure: Safety and tolerability of CS1001 or placebo in combination with platinum-based chemotherapy
timeFrame: up to approximately 5 years
measure: Pharmacokinetics (PK) and immunogenecity of CS1001
timeFrame: up to approximately 5 years
measure: Efficacy of CS1001 monotherapy in subjects cross over to receive CS1001 who experienced progressive disease after assigned to the placebo group in the double-blind phase (CS1001 or placebo in combination with chemotherapy)
timeFrame: up to approximately 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
References:
citation: Zhou C, Wang Z, Sun Y, Cao L, Ma Z, Wu R, Yu Y, Yao W, Chang J, Chen J, Zhuang W, Cui J, Chen X, Lu Y, Shen H, Wang J, Li P, Qin M, Lu D, Yang J. Sugemalimab versus placebo, in combination with platinum-based chemotherapy, as first-line treatment of metastatic non-small-cell lung cancer (GEMSTONE-302): interim and final analyses of a double-blind, randomised, phase 3 clinical trial. Lancet Oncol. 2022 Feb;23(2):220-233. doi: 10.1016/S1470-2045(21)00650-1. Epub 2022 Jan 14.