Adebrelimab and Concurrent Radiochemotherapy as First-line Treatment for Extensive-stage Small-cell Lung Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHenan Cancer Hospital

About this trial

Patients with extensive-stage small-cell lung cancer (ES-SCLC) have poor prognosis, with limited treatment options. Chemo-immunotherapy is the standard 1st-line therapy for patients with ES-SCLC.When 4 cycles of etoposide+carboplatin (EC) or etoposide+cisplatin(EP) chemotherapy combined with PD-L1 inhibitor are effective, guidelines recommend additional thoracic radiotherapy.

In this study, the investigators bring radiotherapy forward, which means that after 2 cycles of EC chemotherapy plus Adebrelimab, participants with response(PR/CR/SD)will receive concurrent radiotherapy and 2 cycles of EC chemotherapy plus Adebrelimab, then maintenance therapy with Adebrelimab (Q3W).

The purpose of this study is to explore the safety and efficacy of Adebrelimab combined with concurrent chemoradiotherapy in untreated participants with extensive-stage small cell lung cancer.

Eligibility criteria

Qualifiers

Aged 18-75 years;

Histologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system) ;

Must sign a written informed consent form prior to any study specific procedures;

No prior treatment for ES-SCLC;

Disqualifiers

Previous treatment with radiochemotherapy for limited-stage small cell lung cancer;

Subjects who previously received systemic antitumor or Immune checkpoint inhibitor therapy ;

Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment;

Active brain metastases, Leptomeningeal metastasis(untreated central nervous system (CNS) metastases unless asymptomatic and lesion size<1cm;

Trial design

Treatments tested in this trial

  • Adebrelimab
  • Radiation Therapy
  • etoposide, carboplatin(EC)

Treatment groups

48 Participants
are divided into 1 treatment group

Sponsors and collaborators

Henan Cancer Hospital

Lead sponsor

Huazhong University of Science and Technology

Collaborator