Back to resultsA Study of CS1001 in Subjects With Stage IV Non-Small Cell Lung Cancer
Primary Purpose
Non Small Cell Lung Cancer
Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
CS1001 monoclonal antibody
CS1001 placebo
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer
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).
- 18-75 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 Criteria:
- 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.
Sites / Locations
- Shanghai Pulmonary Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CS1001 monoclonal antibody
CS1001 placebo
Arm Description
Outcomes
Primary Outcome Measures
Progression-free survival (PFS) in all subjects evaluated by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Secondary Outcome Measures
Overall Survival (OS)
OS defined as the time from randomization to all-cause death.
PFS assessed by BICR
PFS defined as the time from randomization to the first occurrence of disease progression or all-cause death (whichever occurs first), as determined by the BICR according to RECIST v1.1
PFS in subgroup of participants with PD-L1 Expression≥1%, as determined by the investigator
PFS after randomization as determined by the investigator according to RECIST v1.1 in the subgroup of patients with PD-L1 expression ≥1% defined by the SP263 immunohistochemistry (IHC) assay.
Objective Response Rate (ORR) assessed by the investigator according to RECIST v1.1
ORR, defined as the proportion of patients with a complete response (CR) or partial response (PR) on two consecutive occasions >=4 weeks apart, as determined by the investigator according to RECIST v1.1.
Duration of response (DOR) assessed by the investigator according to RECIST v1.1
DOR defined as the time between the date of the earliest qualifying response and the date of progressive disease or all-cause death, whichever occurs first, as determined by the investigator according to RECIST v1.1.
Safety and tolerability of CS1001 or placebo in combination with platinum-based chemotherapy
Pharmacokinetics (PK) and immunogenecity of CS1001
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)
Full Information
NCT ID
NCT03789604
First Posted
December 26, 2018
Last Updated
July 31, 2023
Sponsor
CStone Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT03789604
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 13, 2018 (Actual)
Primary Completion Date
May 15, 2023 (Actual)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CStone Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
479 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CS1001 monoclonal antibody
Arm Type
Experimental
Arm Title
CS1001 placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
CS1001 monoclonal antibody
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
CS1001 placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Progression-free survival (PFS) in all subjects evaluated by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame
up to approximately 5 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS defined as the time from randomization to all-cause death.
Time Frame
up to approximately 7 years
Title
PFS assessed by BICR
Description
PFS defined as the time from randomization to the first occurrence of disease progression or all-cause death (whichever occurs first), as determined by the BICR according to RECIST v1.1
Time Frame
up to approximately 5 years
Title
PFS in subgroup of participants with PD-L1 Expression≥1%, as determined by the investigator
Description
PFS after randomization as determined by the investigator according to RECIST v1.1 in the subgroup of patients with PD-L1 expression ≥1% defined by the SP263 immunohistochemistry (IHC) assay.
Time Frame
up to approximately 5 years
Title
Objective Response Rate (ORR) assessed by the investigator according to RECIST v1.1
Description
ORR, defined as the proportion of patients with a complete response (CR) or partial response (PR) on two consecutive occasions >=4 weeks apart, as determined by the investigator according to RECIST v1.1.
Time Frame
up to approximately 5 years
Title
Duration of response (DOR) assessed by the investigator according to RECIST v1.1
Description
DOR defined as the time between the date of the earliest qualifying response and the date of progressive disease or all-cause death, whichever occurs first, as determined by the investigator according to RECIST v1.1.
Time Frame
up to approximately 5 years
Title
Safety and tolerability of CS1001 or placebo in combination with platinum-based chemotherapy
Time Frame
up to approximately 5 years
Title
Pharmacokinetics (PK) and immunogenecity of CS1001
Time Frame
up to approximately 5 years
Title
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)
Time Frame
up to approximately 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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).
18-75 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 Criteria:
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.
Facility Information:
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
35038432
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.
Results Reference
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A Study of CS1001 in Subjects With Stage IV Non-Small Cell Lung Cancer
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