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

Extensive-stage Small Cell Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03711305
• Other study ID #: SHR-1316-III-301
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 30, 2018
• Est. completion date: December 2023

Study information

• Verified date: April 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 462
• Est. completion date: December 2023
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Extensive-stage Small Cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• SHR-1316
SHR-1316 intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6) and maintenance phase.
• Carboplatin
Carboplatin intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).
• Etoposide
Etoposide intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).
• Placebo
Placebo intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6) and maintenance phase.

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	Jilin Cancer Hospital	Jilin	Changchun

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Overall Survival (OS)	Baseline until death from any cause	up to approximately 31 months
Secondary	Duration of Progression-Free Survival (PFS) as Assessed Using RECIST v1.1		up to approximately 6 months
Secondary	Percentage of Participants With Objective Response (OR) as Assessed by the Investigator Using RECIST v1.1	Baseline until partial response (PR) or complete response (CR), whichever occurs first	up to approximately 31 months
Secondary	Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1	First occurrence of PR or CR until PD or death, whichever occurs first	up to approximately 31 months
Secondary	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
Secondary	Percentage of Participants Alive at 1 Year and 2 Years		1 year, 2 years
Secondary	Percentage of Participants with Adverse Events Or Serious Adverse Events.		up to approximately 31 months