Extensive-stage Small Cell Lung Cancer
Conditions
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.
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.
Interventions
DRUGSHR-1316
SHR-1316 intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6) and maintenance phase.
DRUGCarboplatin
Carboplatin intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).
DRUGEtoposide
Etoposide intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).
DRUGPlacebo
Placebo intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6) and maintenance phase.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Overall Survival (OS) | up to approximately 31 months | Baseline until death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Progression-Free Survival (PFS) as Assessed Using RECIST v1.1 | up to approximately 6 months | — |
| Percentage of Participants With Objective Response (OR) as Assessed by the Investigator Using RECIST v1.1 | up to approximately 31 months | Baseline until partial response (PR) or complete response (CR), whichever occurs first |
| Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1 | up to approximately 31 months | First occurrence of PR or CR until PD or death, whichever occurs first |
| Percentage of Participants Alive and Without PD, as Assessed by the Investigator Using RECIST v1.1, at 6 Months and 1 Year | 6 months, 1 year | — |
| Percentage of Participants Alive at 1 Year and 2 Years | 1 year, 2 years | — |
| Percentage of Participants with Adverse Events Or Serious Adverse Events. | up to approximately 31 months | — |
Countries
China
Outcome results
None listed