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

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ClinicalTrials.gov Identifier: NCT03789604
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : October 31, 2019
Sponsor:
Information provided by (Responsible Party):
CStone Pharmaceuticals

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).

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Biological: CS1001 monoclonal antibody Biological: CS1001 placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 13, 2018
Estimated Primary Completion Date : September 28, 2020
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: CS1001 monoclonal antibody Biological: CS1001 monoclonal antibody
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

Placebo Comparator: CS1001 placebo Biological: CS1001 placebo
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 Measures :
  1. Progression-free survival (PFS) in subjects with PD-L1≥ 1% and PFS in all subjects evaluated by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: from the date of randomization to the first date of recorded progression or all-cause death, whichever comes first, assessed up to 30 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789604


Contacts
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Contact: Wendie Yuan +86 21 61097678 cstonera@cstonepharma.com

Locations
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China, Shanghai
Shanghai Pulmonary Hospital Recruiting
Shanghai, Shanghai, China
Contact: Caichun Zhou         
Sponsors and Collaborators
CStone Pharmaceuticals

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Responsible Party: CStone Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03789604     History of Changes
Other Study ID Numbers: CS1001-302
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents, Immunological
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents