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

Last updated: December 11, 2023
Sponsor: Nanfang Hospital, Southern Medical University
Overall Status: Active - Recruiting

Phase

2

Condition

Lung Cancer

Carcinoma

Recurrent Respiratory Papillomatosis

Treatment

Etoposide

Carboplatin/Cisplatin

Adebrelimab

Clinical Study ID

NCT06177925
NFEC-2023-465
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed inform consent form
  • Age >= 18 years and <= 75 years
  • Histologically or cytologically confirmed ES-SCLC (per the Veterans AdministrationLung Study Group [VALG] staging system),the number of metastatic lesions ≤ 5, thenumber of metastatic organs ≤ 3, and no previous systemic chemotherapy, radiotherapyor 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

Exclusion Criteria:

  • Spinal cord compression not definitively treated with surgery and/or radiation orpreviously diagnosed and treated spinal cord compression without evidence that diseasehas been clinically stable for ≥ 1 week prior to randomization
  • Leptomeningeal disease
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrentdrainage procedures
  • Uncontrolled or symptomatic hypercalcemia
  • Malignancies other than SCLC within 5 years prior to randomization, with the exceptionof those with a negligible risk of metastasis or death treated with expected curativeoutcome
  • History of autoimmune disease, including but not limited to myasthenia gravis,autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatorybowel 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 14days of first administration of study treatment. Inhaled or topical steroids, andadrenal 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 torandomization
  • History of hypersensitivity reactions to chimeric or humanized antibodies or fusionproteins, carboplatin or etoposide
  • History or current evidence of any condition, therapy, or laboratory abnormality thatmight confound the results of the study, interfere with the subject's participationfor the full duration of the study, or is not in the best interest of the subject toparticipate, in the opinion of the treating investigator

Study Design

Total Participants: 62
Treatment Group(s): 4
Primary Treatment: Etoposide
Phase: 2
Study Start date:
December 10, 2023
Estimated Completion Date:
September 30, 2026

Study 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.

Connect with a study center

  • Nanfang Hospital, Southern Medical University

    Guangzhou,
    China

    Active - Recruiting

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