A Phase Ⅱ Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy for Extensive-Stage Oligometastatic SCLC

Neoplasms Clinical Trial

Official title:

A Phase Ⅱ Exploratory Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy as First-Line Treatment for Extensive-Stage Oligometastatic Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06177925
• Other study ID #: NFEC-2023-465
• Status: Recruiting
• Phase: Phase 2
• Start date: December 10, 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: December 2023
• Source: Nanfang Hospital, Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, single arm Phase II study designed to evaluate the efficacy and safety of adebelizumab combined with carboplatin/Cisplatin plus (+) etoposide and concurrent radiotherapy in the first-line treatment of patients with extensive stage oligometastatic small cell lung cancer.

Description:

Participants will receive Adebrelimab intravenously in combination with carboplatin /Cisplatin and etoposide during the induction phase (2 Cycles ). Thereafter, participants will receive concurrent chemoradiotherapy(thoracic radiation therapy and SBRT for metastases,combination with carboplatin /Cisplatin and etoposide for 1-2 Cycles).Then participants will receive Adebrelimab combination with carboplatin /Cisplatin and etoposide for 1-2 Cycles,followed by Adebrelimab maintenance until persistent radiographic PD, intolerable toxicity or withdrawal of consent during the maintenance phase.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: September 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Signed inform consent form
• Age >= 18 years and <= 75 years
• Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system),the number of metastatic lesions = 5, the number of metastatic organs = 3, and no previous systemic chemotherapy, radiotherapy or immune checkpoint inhibitor treatment.
• Eastern Cooperative Oncology Group performance status of 0 or 1
• Expected survival time = 3 months
• Patients must submit a pre-treatment tumor tissue sample during the study.
• Adequate hematologic and end organ function

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
• Treatment with systemic immunosuppressive medications within 1 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

• Bronchial Neoplasms
• Carcinoma
• Carcinoma, Bronchogenic
• Lung Diseases
• Lung Neoplasms
• Neoplasms
• Neoplasms by Site
• Respiratory Tract Diseases
• Respiratory Tract Neoplasms
• Small Cell Lung Carcinoma
• Thoracic Neoplasms

Intervention

Drug:
• Adebrelimab
Adebrelimab intravenous infusion will be administered during the induction phase (Cycles 1-2 ) and maintenance phase.
• Carboplatin/Cisplatin
Carboplatin/Cisplatin intravenous infusion will be administered during the induction phase, concurrent chemoradiotherapy phase and maintenance phase(Cycles 1-4 or 6).
• Etoposide
Etoposide intravenous infusion will be administered during the induction phase, concurrent chemoradiotherapy phase and maintenance phase(Cycles 1-4 or 6).

Radiation:
• Radiation therapy
IMRT for thoracic of 45--55Gy in 15-22 fractions,SBRT for metastases during the concurrent chemoradiotherapy phase

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guangzhou

Sponsors (2)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University	Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS)		up to approximately 30 months
Secondary	Overall Survival (OS)		up to approximately 30 months
Secondary	Objective Response Rate (ORR)		up to approximately 30 months
Secondary	Disease control rate (DCR)		up to approximately 30 months
Secondary	Duration of Response (DOR)		up to approximately 30 months
Secondary	Percentage of Participants Alive at 1 Year and 2 Years		1 year, 2 years
Secondary	Percentage of Participants Alive and Without PD at 6 Months and 1 Year		6 months, 1 year
Secondary	Percentage of Participants with Adverse Events Or Serious Adverse Events		up to approximately 30 months