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Study of Carboplatin Plus Etoposide With or Without SHR-1316 in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)

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ClinicalTrials.gov Identifier: NCT03711305
Recruitment Status : Unknown
Verified April 2022 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : October 18, 2018
Last Update Posted : April 18, 2022
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Extensive-stage Small Cell Lung Cancer Drug: SHR-1316 Drug: Carboplatin Drug: Etoposide Drug: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 462 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : December 30, 2018
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: SHR-1316
SHR-1316 intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6) and maintenance phase.

Drug: Carboplatin
Carboplatin intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).

Drug: Etoposide
Etoposide intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).
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.
 Drug: Carboplatin
Carboplatin intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).

Drug: Etoposide
Etoposide intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).

Drug: Placebo
Placebo intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6) and maintenance phase.


Outcome Measures
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Primary Outcome Measures :
  1. Duration of Overall Survival (OS) [ Time Frame: up to approximately 31 months ]
    Baseline until death from any cause


Secondary Outcome Measures :
  1. Duration of Progression-Free Survival (PFS) as Assessed Using RECIST v1.1 [ Time Frame: up to approximately 6 months ]
  2. Percentage of Participants With Objective Response (OR) as Assessed by the Investigator Using RECIST v1.1 [ Time Frame: up to approximately 31 months ]
    Baseline until partial response (PR) or complete response (CR), whichever occurs first

  3. Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1 [ Time Frame: up to approximately 31 months ]
    First occurrence of PR or CR until PD or death, whichever occurs first

  4. 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 ]
  5. Percentage of Participants Alive at 1 Year and 2 Years [ Time Frame: 1 year, 2 years ]
  6. Percentage of Participants with Adverse Events Or Serious Adverse Events. [ Time Frame: up to approximately 31 months ]

Eligibility Criteria
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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:

  • 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
Contacts and Locations
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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): NCT03711305


Locations
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China, Beijing
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing, China
China, Changchun
Jilin Cancer Hospital
Jilin, Changchun, China
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Study Director: Wei Shi Jiangsu HengRui Medicine Co., Ltd.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03711305    
Other Study ID Numbers: SHR-1316-III-301
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: April 18, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
 Bronchial Neoplasms
Carboplatin
Etoposide
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action