- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03728556
A Study of CS1001 in Subjects With Stage III Non-Small Cell Lung Cancer
June 14, 2023 updated by: CStone Pharmaceuticals
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
381
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510080
- Guangdong Provincial People's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Willing to participate in this trial; fully understand and informed of this trial, and able to provide written informed consent form (ICF).
- ≥ 18 years of age on the day of signing ICF.
- Have histologically confirmed locally advanced/unresectable stage III non-small cell lung cancer.
- The first dose of CS1001 will be administered within 1 - 42 days (including 42 days) after concurrent/sequential chemoradiotherapy is completed.
- Platinum-containing chemotherapy.
- Absence of progression after concurrent/sequential chemoradiotherapy.
- Eastern Cooperative Oncology Group(ECOG) Perfomance Status (PS) of 0 or 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 baseline or ≤ Grade 1 (according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v4.03).
- Subjects must have adequate organ function as assessed in the following laboratory tests.
- 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:
- Histologically identified to have mixed small cell lung cancer component.
- Disease progression after concurrent/sequential chemoradiotherapy.
- Major surgical procedure (as determined by investigators) within 28 days prior to the first dose of investigational product.
- Has received a live vaccine within 28 days prior to the first dose of investigational product.
- 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.)
- 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.).
- Subjects with current active autoimmune disease or prior history of autoimmune disease that probably will relapse or at risk of having these conditions.
- 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.
- A known additional malignancy within 5 years prior to the first dose of investigational product.
- History of inflammatory bowel disease or active inflammatory bowel disease (for example Crohn's disease or ulcerative colitis).
- Known history of human immunodeficiency virus (HIV) infection and/or acquired immune deficiency syndrome.
- Subjects at active phase of chronic hepatitis B or with active hepatitis C.
- History of organ transplantation.
- Subjects with known history of alcoholism or drugs abuse.
- Severe allergic reaction to other monoclonal antibodies.
- QTc interval > 480 msec on the screening electrocardiogram (ECG) (as calculated by Fridericia formula).
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CS1001monoclonal antibody
|
Participant will receive CS1001 monoclonal antibody 1200 mg by intravenous infusion every 3 weeks, for up to 24 months
|
Placebo Comparator: CS1001 Placebo
|
Participant will receive CS1001 placebo by intravenous infusion every 3 weeks, for up to 24 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
from the date of randomization to the first date of recorded progression or all-cause death, whichever comes first, assessed up to 30 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Qing Zhou, Guangdong Provincial People's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 26, 2018
Primary Completion (Actual)
April 3, 2023
Study Completion (Actual)
April 3, 2023
Study Registration Dates
First Submitted
October 25, 2018
First Submitted That Met QC Criteria
November 1, 2018
First Posted (Actual)
November 2, 2018
Study Record Updates
Last Update Posted (Actual)
June 15, 2023
Last Update Submitted That Met QC Criteria
June 14, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CS1001-301
- CTR20181429 (Other Identifier: www.chinadrugtrials.org.cn)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non-Small Cell Lung Cancer Stage III
-
Oslo University HospitalAstraZenecaActive, not recruitingCancer | NSCLC | Non Small Cell Lung Cancer | NSCLC, Stage III | Non Small Cell Lung Cancer Stage IIINorway, Finland, Lithuania, Estonia
-
Memorial Sloan Kettering Cancer CenterAstraZenecaRecruitingNSCLC | Lung Cancer | Non-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | PD-L1 Gene Mutation | Non-small Cell Lung Cancer Stage IIIA | Non-small Cell Lung Cancer Stage IIUnited States
-
Alexander ChiNot yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Carcinoma | Non-small Cell Lung Cancer Stage IIChina
-
Stanford UniversityAstraZenecaRecruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Lung Cancer Stage IIUnited States
-
Northwestern UniversityBristol-Myers Squibb; National Cancer Institute (NCI)UnknownStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage III Non-Small Cell Lung CancerUnited States
-
AIO-Studien-gGmbHBristol-Myers Squibb; Eli Lilly and Company; Merck Sharp & Dohme LLC; Pfizer; Gilead... and other collaboratorsRecruitingSmall-cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer Stage I | Metastatic Non-small Cell Lung Cancer (NSCLC) | Non Small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer Stage IIGermany
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedStage IV Non-Small Cell Lung Cancer AJCC v7 | Stage IIIA Non-Small Cell Lung Cancer AJCC v7 | Stage III Non-Small Cell Lung Cancer AJCC v7 | Stage IIIB Non-Small Cell Lung Cancer AJCC v7United States
-
Mayo ClinicNational Cancer Institute (NCI)TerminatedStage IV Non-Small Cell Lung Cancer AJCC v7 | Stage IIIA Non-Small Cell Lung Cancer AJCC v7 | Stage III Non-Small Cell Lung Cancer AJCC v7 | Stage IIIB Non-Small Cell Lung Cancer AJCC v7 | Mesothelin PositiveUnited States
-
M.D. Anderson Cancer CenterRecruitingStage III Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7 | Stage IIIC Lung Cancer AJCC v8 | Stage IIIB Lung Non-Small Cell Cancer AJCC v7 | Stage III Lung Non-Small Cell Cancer AJCC v7United States
-
National Cancer Institute (NCI)NRG OncologyTerminatedStage IIIA Non-Small Cell Lung Cancer AJCC v7 | Stage III Non-Small Cell Lung Cancer AJCC v7 | Stage IIIB Non-Small Cell Lung Cancer AJCC v7United States
Clinical Trials on CS1001 monoclonal antibody
-
CStone PharmaceuticalsActive, not recruitingNon Small Cell Lung CancerChina
-
CStone PharmaceuticalsCompletedGastric Adenocarcinoma | Gastroesophageal Junction AdenocarcinomaChina
-
Suzhou Zelgen Biopharmaceuticals Co.,LtdCStone PharmaceuticalsRecruitingAdvanced Solid TumorChina
-
CStone PharmaceuticalsCompletedRelapsed Small Cell Lung CancerChina
-
CStone PharmaceuticalsCompletedHodgkin LymphomaChina
-
CStone PharmaceuticalsCompletedExtranodal Natural Killer/T-Cell LymphomaUnited States, China
-
CStone PharmaceuticalsCompleted
-
CStone PharmaceuticalsCompleted
-
CStone PharmaceuticalsBayerCompletedAdvanced Refractory Solid TumorsAustralia
-
CStone PharmaceuticalsBlueprint Medicines CorporationCompletedHepatocellular CarcinomaChina