- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03711305
Study of Carboplatin Plus Etoposide With or Without SHR-1316 in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)
April 14, 2022 updated by: Jiangsu HengRui Medicine Co., Ltd.
Randomized, Double-blinded, Placebo Controlled, Multicenter, Phase III Study of Carboplatin Plus Etoposide With or Without SHR-1316 in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)
This randomized, double-blinded, placebo-controlled phase III, multicenter study is designed to evaluate the safety and efficacy of SHR-1316 in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Participants will be randomized in a 1:1 ratio to receive either SHR-1316 + carboplatin + etoposide or placebo + carboplatin + etoposide for 4-6 cycles in the induction phase followed by maintenance with SHR-1316 or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Treatment can be continued until persistent radiographic PD or or unacceptable toxicity.
Study Type
Interventional
Enrollment (Actual)
462
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
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Beijing
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Beijing, Beijing, China
- Cancer Hospital Chinese Academy of Medical Sciences
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Changchun
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Jilin, Changchun, China
- Jilin cancer hospital
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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 to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age >= 18 years and <= 75 years
- Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system)
- Eastern Cooperative Oncology Group performance status of 0 or 1
- No prior systemic treatment or immune checkpoint inhibitor treatment for ES-SCLC
- At least 6 months treatment-free period since last chemo/radiotherapy with curative intent for limited-stage SCLC
- Measurable disease, as defined by RECIST v1.1
- Adequate hematologic and end organ function
- Patients must submit a pre-treatment tumor tissue sample during the study.
- Signed inform consent form
Exclusion Criteria:• Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation
- Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 1 week prior to randomization
- Leptomeningeal disease
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Uncontrolled or symptomatic hypercalcemia
- Malignancies other than SCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
- History of autoimmune disease, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease
- Prior treatment with immune checkpoint blockade therapies
- Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid are permitted in the absence of active autoimmune disease.
- Significant cardiovascular disease
- Prior allogeneic bone marrow transplantation or solid organ transplant
- Treatment with systemic immunosuppressive medications within 2 weeks prior to randomization
- History of hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins, carboplatin or etoposide
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: SHR-1316 + carboplatin + etoposide
Participants will receive SHR-1316 intravenously in combination with carboplatin and etoposide during the induction phase (Cycles 1-4 or 6).
Thereafter, participants will receive maintenance (after induction phase) SHR-1316 until persistent radiographic PD, intolerable toxicity or withdrawal of consent.
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SHR-1316 intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6) and maintenance phase.
Carboplatin intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).
Etoposide intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).
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Active Comparator: Placebo + carboplatin + etoposide
Participants will receive placebo intravenously in combination with carboplatin and etoposide during the induction phase (Cycles 1-4 or 6).
Thereafter, participants will receive maintenance (after induction phase) placebo until persistent radiographic PD, intolerable toxicity or withdrawal of consent.
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Carboplatin intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).
Etoposide intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).
Placebo intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6) and maintenance phase.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of Overall Survival (OS)
Time Frame: up to approximately 31 months
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Baseline until death from any cause
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up to approximately 31 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of Progression-Free Survival (PFS) as Assessed Using RECIST v1.1
Time Frame: up to approximately 6 months
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up to approximately 6 months
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Percentage of Participants With Objective Response (OR) as Assessed by the Investigator Using RECIST v1.1
Time Frame: up to approximately 31 months
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Baseline until partial response (PR) or complete response (CR), whichever occurs first
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up to approximately 31 months
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Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1
Time Frame: up to approximately 31 months
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First occurrence of PR or CR until PD or death, whichever occurs first
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up to approximately 31 months
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Percentage of Participants Alive and Without PD, as Assessed by the Investigator Using RECIST v1.1, at 6 Months and 1 Year
Time Frame: 6 months, 1 year
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6 months, 1 year
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Percentage of Participants Alive at 1 Year and 2 Years
Time Frame: 1 year, 2 years
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1 year, 2 years
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Percentage of Participants with Adverse Events Or Serious Adverse Events.
Time Frame: up to approximately 31 months
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up to approximately 31 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Wei Shi, Jiangsu HengRui Medicine Co., Ltd.
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)
December 30, 2018
Primary Completion (Anticipated)
October 1, 2022
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
October 16, 2018
First Submitted That Met QC Criteria
October 16, 2018
First Posted (Actual)
October 18, 2018
Study Record Updates
Last Update Posted (Actual)
April 18, 2022
Last Update Submitted That Met QC Criteria
April 14, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Carboplatin
- Etoposide
Other Study ID Numbers
- SHR-1316-III-301
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
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.
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