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NCT06236997Not yet recruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 1 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
48 (estimated)
First submitted
11 Jan 2024
Start date
10 Feb 2024
Primary completion date
31 May 2026
Lead sponsor
Henan Cancer Hospital
Diseases
Lung cancer
NCT number
NCT06236997

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 48
  • From 10 Feb 2024 to the primary completion date, 31 May 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous treatment with radiochemotherapy for limited-stage small cell lung cancer;
  • Subjects who previously received systemic antitumor or Immune checkpoint inhibitor therapy ;

Other illness

  • 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;

Other

  • Active brain metastases, Leptomeningeal metastasis(untreated central nervous system (CNS) metastases unless asymptomatic and lesion size\<1cm;
  • Patients with spinal cord compression;
  • Patients with multiple liver metastases(except isolated lesion and lesion size\<2cm);
  • Uncontrollable third cavity effusion (e.g. a large amount of pleural effusion, ascites, or pericardial effusion, etc.) requiring repeated drainage, which was judged by the investigator to be unsuitable for study;
  • The investigator judges that there are any patients who endanger the patient's safety, interfere with the study assessment, and have poor compliance.

Who the study is looking for

  • 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;
  • No more than 5 lesions (including metastases),and at least one measurable lesion that meets RECIST 1.1 evaluation criteria;
  • Life expectancy more than 3 months;
  • ECOG PS 0-1

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Coordinator of this site? Confirm its status
WuhanChinaUnknown status
Henan Cancer Hospital
Coordinator of this site? Confirm its status
ZhengzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.