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

December 11, 2023 updated by: Nanfang Hospital, Southern Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Guangzhou, China
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (Adebrelimab, chemotherapy, radiation therapy)
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.
Drug: Adebrelimab
Adebrelimab intravenous infusion will be administered during the induction phase (Cycles 1-2 ) and maintenance phase.
Drug: Carboplatin/Cisplatin
Carboplatin/Cisplatin intravenous infusion will be administered during the induction phase, concurrent chemoradiotherapy phase and maintenance phase(Cycles 1-4 or 6).
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-Free Survival (PFS)
Time Frame: up to approximately 30 months
up to approximately 30 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Alive at 1 Year and 2 Years
Time Frame: 1 year, 2 years
1 year, 2 years
Overall Survival (OS)
Time Frame: up to approximately 30 months
up to approximately 30 months
Objective Response Rate (ORR)
Time Frame: up to approximately 30 months
up to approximately 30 months
Disease control rate (DCR)
Time Frame: up to approximately 30 months
up to approximately 30 months
Duration of Response (DOR)
Time Frame: up to approximately 30 months
up to approximately 30 months
Percentage of Participants Alive and Without PD at 6 Months and 1 Year
Time Frame: 6 months, 1 year
6 months, 1 year
Percentage of Participants with Adverse Events Or Serious Adverse Events
Time Frame: up to approximately 30 months
up to approximately 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital, Southern Medical University

Collaborators

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 10, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

December 11, 2023

First Submitted That Met QC Criteria

December 11, 2023

First Posted (Estimated)

December 20, 2023

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2023-465

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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