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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03728556
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
CStone Pharmaceuticals

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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 26, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CS1001monoclonal antibody Biological: CS1001 monoclonal antibody
Participant will receive CS1001 monoclonal antibody 1200 mg by intravenous infusion every 3 weeks, for up to 24 months

Placebo Comparator: CS1001 Placebo Biological: CS1001 placebo
Participant will receive CS1001 placebo by intravenous infusion every 3 weeks, for up to 24 months




Primary Outcome Measures :
  1. 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 investigators according to response evaluation criteria in solid tumors RECIST v1.1)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (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 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.

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): NCT03728556


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

Locations
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China, Guangdong
Guangdong Provincial People's Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Yilong Wu, Professor         
Sponsors and Collaborators
CStone Pharmaceuticals
Investigators
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Principal Investigator: Qing Zhou Guangdong Provincial People's Hospital
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Responsible Party: CStone Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03728556    
Other Study ID Numbers: CS1001-301
CTR20181429 ( Other Identifier: www.chinadrugtrials.org.cn )
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs