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

NCT03789604 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: CS1001-302
• Study Type: interventional
• Target: 479
• Locations: 1 country
• Sites: 1

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).

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) in all subjects evaluated by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  up to approximately 5 years

Secondary Outcomes (8)

• Overall Survival (OS)

  up to approximately 7 years

• PFS assessed by BICR

  up to approximately 5 years

• PFS in subgroup of participants with PD-L1 Expression≥1%, as determined by the investigator

  up to approximately 5 years

• Objective Response Rate (ORR) assessed by the investigator according to RECIST v1.1

  up to approximately 5 years

• Duration of response (DOR) assessed by the investigator according to RECIST v1.1

  up to approximately 5 years

Study Arms (2)

CS1001 monoclonal antibody

EXPERIMENTAL

Biological: CS1001 monoclonal antibody

CS1001 placebo

PLACEBO COMPARATOR

Biological: CS1001 placebo

Interventions

CS1001 monoclonal antibody BIOLOGICAL

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

CS1001 monoclonal antibody

CS1001 placebo BIOLOGICAL

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

CS1001 placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to participate in this trial; fully understand and informed of this trial, and able to provide written informed consent form (ICF).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CStone Pharmaceuticals: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Location

Related Publications (3)

• Zhou C, Wang Z, Sun M, Cao L, Ma Z, Wu R, Yu Y, Yao W, Sun S, Chen J, Zhuang W, Cui J, Chen X, Lu Y, Shen H, Hu C, Liu J, Liu Y, Wang M, Li X, Sun P, Shu Y, Zhou J, Li J, Gu K, Wang C, Zhao H, Zhang Y, Liu C, Yang H, Zhang X, Ma R, Li L, Liang L, Li M, Wang J, Wang Q, Wang B, Dai H, Shi Q, Yang J. Sugemalimab versus placebo, in combination with platinum-based chemotherapy, as first-line treatment of metastatic non-small-cell lung cancer (GEMSTONE-302): 4-year outcomes from a double-blind, randomised, phase 3 trial. Lancet Oncol. 2025 Jul;26(7):887-897. doi: 10.1016/S1470-2045(25)00198-6. Epub 2025 Jun 13.

  PMID: 40523368 DERIVED

• Zhou C, Wang Z, Sun M, Cao L, Ma Z, Wu R, Yu Y, Yao W, Sun S, Chen J, Zhuang W, Cui J, Chen X, Lu Y, Shen H, Hu C, Liu J, Liu Y, Wang M, Li X, Sun P, Shu Y, Zhou J, Li J, Gu K, Wang C, Zhao H, Zhang Y, Liu C, Wang J, Chen R, Qin M, Wang H, Yang J. Interim survival analysis of the randomized phase III GEMSTONE-302 trial: sugemalimab or placebo plus chemotherapy as first-line treatment for metastatic NSCLC. Nat Cancer. 2023 Jun;4(6):860-871. doi: 10.1038/s43018-023-00578-z. Epub 2023 Jun 15.

  PMID: 37322367 DERIVED

• 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.

  PMID: 35038432 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2018
• First Posted: December 28, 2018
• Study Start: December 13, 2018
• Primary Completion: May 15, 2023
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

CN (1)