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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) | Clinical Trials | Clareo Health

UNKNOWNPHASE3

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

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)

NCT03711305•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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

•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
+3 more criteria

Locations (2)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Jilin Cancer Hospital

Jilin, Changchun, China

Key Dates

Start Date

December 30, 2018

Primary Completion Date

October 1, 2022

Completion Date

December 1, 2023

Last Updated

April 18, 2022

Enrollment

462

ACTUAL participants

Conditions

Extensive-stage Small Cell Lung Cancer

Interventions

SHR-1316

DRUG

Carboplatin

DRUG

Etoposide

DRUG

Placebo

DRUG

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ACTIVE_NOT_RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

A Study to Compare the Efficacy and Safety of BMS-986489 (BMS-986012+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).

Personalized Neoantigen Vaccine in Combination With Durvalumab (MEDI4736) in Extensive Stage Small Cell Lung Cancer

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Nano-crystalline Megestrol Acetate Combined With Standard Treatment Versus Standard Treatment for First-line Extensive-stage Small Cell Lung Cancer in the Cachexia Phase

Nanocrystalline Megestrol Acetate for the Treatment of Anorexia-Cachexia Syndrome in Extensive-Stage Small Cell Lung Cancer: A Prospective, Open-Label, Single-Arm Phase II Clinical Study