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

NCT03711305 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: SHR-1316-III-301
• Study Type: interventional
• Target: 462
• Locations: 1 country
• Sites: 2

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.

Conditions

Extensive-stage Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Duration of Overall Survival (OS)

  Baseline until death from any cause

  up to approximately 31 months

Secondary Outcomes (6)

• 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

• Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1

  up to approximately 31 months

• 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

Study Arms (2)

SHR-1316 + carboplatin + etoposide

EXPERIMENTAL

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; Drug: Carboplatin; Drug: Etoposide

Placebo + carboplatin + etoposide

ACTIVE COMPARATOR

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; Drug: Etoposide; Drug: Placebo

Interventions

SHR-1316 DRUG

SHR-1316 intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6) and maintenance phase.

SHR-1316 + carboplatin + etoposide

Carboplatin DRUG

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

Placebo + carboplatin + etoposide; SHR-1316 + carboplatin + etoposide

Etoposide DRUG

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

Placebo + carboplatin + etoposide; SHR-1316 + carboplatin + etoposide

Placebo DRUG

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

Placebo + carboplatin + etoposide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (2)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Location

Jilin Cancer Hospital

Jilin, Changchun, China

Location

Related Publications (2)

• Long Y, Wang H, Xie X, Li J, Xu Y, Zhou Y. Updated cost-effectiveness analysis of adebrelimab plus chemotherapy for extensive-stage small cell lung cancer in China. BMJ Open. 2024 Apr 5;14(4):e077090. doi: 10.1136/bmjopen-2023-077090.

  PMID: 38582540 DERIVED

• Wang J, Zhou C, Yao W, Wang Q, Min X, Chen G, Xu X, Li X, Xu F, Fang Y, Yang R, Yu G, Gong Y, Zhao J, Fan Y, Liu Q, Cao L, Yao Y, Liu Y, Li X, Wu J, He Z, Lu K, Jiang L, Hu C, Zhao W, Zhang B, Shi W, Zhang X, Cheng Y; CAPSTONE-1 Study Group. Adebrelimab or placebo plus carboplatin and etoposide as first-line treatment for extensive-stage small-cell lung cancer (CAPSTONE-1): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2022 Jun;23(6):739-747. doi: 10.1016/S1470-2045(22)00224-8. Epub 2022 May 13.

  PMID: 35576956 DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Carboplatin; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Wei Shi

  Jiangsu HengRui Medicine Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 18, 2018
• Study Start: December 30, 2018
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2023
• Last Updated: April 18, 2022

Record last verified: 2022-04

Locations

CN (2)