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

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ClinicalTrials.gov Identifier: NCT03728556
Recruitment Status : Active, not recruiting
First Posted : November 2, 2018
Last Update Posted : March 1, 2021
Sponsor:
Information provided by (Responsible Party):
CStone Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE October 25, 2018
First Posted Date  ICMJE November 2, 2018
Last Update Posted Date March 1, 2021
Actual Study Start Date  ICMJE October 26, 2018
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2021)
Progress Free Survival (PFS) [ 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. ]
The primary endpoint is the PFS of CS1001 versus placebo (evaluated by blinded independent central review(BICR) according to response evaluation criteria in solid tumors RECIST v1.1).
Original Primary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
Progress Free Survival (PFS) [ Time Frame: from the date of randomization to the first date of recorded progression or all-cause death, whichever comes first, assessed up to 24 months ]
The primary endpoint is the PFS of CS1001 versus placebo (evaluated by investigators according to response evaluation criteria in solid tumors RECIST v1.1)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of CS1001 in Subjects With Stage III Non-Small Cell Lung Cancer
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Trial of CS1001 as Consolidation Treatment in Subjects With Locally Advanced/Unresectable (Stage III) Non-Small Cell Lung Cancer That Has Not Progressed After Prior Concurrent/Sequential Chemoradiotherapy
Brief Summary This is a randomized, double-blind, placebo-controlled, multicenter phase III study to evaluate the efficacy and safety of CS1001 in subjects with locally advanced/unresectable (Stage III) non-small cell lung cancer that has not progressed after prior concurrent/sequential chemoradiotherapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer Stage III
Intervention  ICMJE
  • Biological: CS1001 monoclonal antibody
    Participant will receive CS1001 monoclonal antibody 1200 mg by intravenous infusion every 3 weeks, for up to 24 months
  • Biological: CS1001 placebo
    Participant will receive CS1001 placebo by intravenous infusion every 3 weeks, for up to 24 months
Study Arms  ICMJE
  • Experimental: CS1001monoclonal antibody
    Intervention: Biological: CS1001 monoclonal antibody
  • Placebo Comparator: CS1001 Placebo
    Intervention: Biological: CS1001 placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 25, 2021)
381
Original Estimated Enrollment  ICMJE
 (submitted: November 1, 2018)
402
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 years of age on the day of signing ICF.
  3. Have histologically confirmed locally advanced/unresectable stage III non-small cell lung cancer.
  4. The first dose of CS1001 will be administered within 1 - 42 days (including 42 days) after concurrent/sequential chemoradiotherapy is completed.
  5. Platinum-containing chemotherapy.
  6. Absence of progression after concurrent/sequential chemoradiotherapy.
  7. Eastern Cooperative Oncology Group(ECOG) Perfomance Status (PS) of 0 or 1.
  8. Life expectancy ≥ 12 weeks.
  9. 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 baseline or ≤ Grade 1 (according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v4.03).
  10. Subjects must have adequate organ function as assessed in the following laboratory tests.
  11. Women of childbearing potential or fertile men must agree to use an effective method of birth control from providing signed ICF and for 180 days after last dose of investigational product. Women of childbearing potential include premenopausal women and women whose menopause started within prior 2 years. Women of childbearing potential must have a negative pregnancy test ≤7 days prior to the first dose of experimental drug.

Exclusion Criteria:

  1. Histologically identified to have mixed small cell lung cancer component.
  2. Disease progression after concurrent/sequential chemoradiotherapy.
  3. Major surgical procedure (as determined by investigators) within 28 days prior to the first dose of investigational product.
  4. Has received a live vaccine within 28 days prior to the first dose of investigational product.
  5. Current participation in another clinical study or use of any investigational drug within 28 days prior to the first dose of investigational product in this trial. (Participation in the overall survival follow-up of a study is allowed.)
  6. Any prior treatment of antibody/drug that targets at T-cell coregulatory proteins (immune checkpoints, including PD-1, PD-L1, CTLA4, TIM3 and LAG3, etc.).
  7. Subjects with current active autoimmune disease or prior history of autoimmune disease that probably will relapse or at risk of having these conditions.
  8. Immune deficient disease or systemic corticosteroid treatment within 7 days prior to the first dose of investigational product, or any other form of immune suppressing treatment.
  9. A known additional malignancy within 5 years prior to the first dose of investigational product.
  10. History of inflammatory bowel disease or active inflammatory bowel disease (for example Crohn's disease or ulcerative colitis).
  11. Known history of human immunodeficiency virus (HIV) infection and/or acquired immune deficiency syndrome.
  12. Subjects at active phase of chronic hepatitis B or with active hepatitis C.
  13. History of organ transplantation.
  14. Subjects with known history of alcoholism or drugs abuse.
  15. Severe allergic reaction to other monoclonal antibodies.
  16. QTc interval > 480 msec on the screening electrocardiogram (ECG) (as calculated by Fridericia formula).
  17. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03728556
Other Study ID Numbers  ICMJE CS1001-301
CTR20181429 ( Other Identifier: www.chinadrugtrials.org.cn )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CStone Pharmaceuticals
Study Sponsor  ICMJE CStone Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Qing Zhou Guangdong Provincial People's Hospital
PRS Account CStone Pharmaceuticals
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP