Clinical trial · Interventional
A Study of CS1001 in Subjects With Stage IV Non-Small Cell Lung Cancer
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
NCT03789604CI-TRIAL-00122540completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CS1001 monoclonal antibody | Biological | — | UNRESOLVED |
| CS1001 placebo | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CS1001 monoclonal antibody
- interventionNames
- Biological: CS1001 monoclonal antibody
- type
- PLACEBO_COMPARATOR
- label
- CS1001 placebo
- interventionNames
- Biological: CS1001 placebo
Primary outcomes (1)
- 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 (8)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (3)
- DERIVEDZhou 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
- DERIVEDZhou 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
- DERIVEDZhou 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