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

NCT06236997 · tracked via the Priya Life Science China tracker

Sponsor

Henan Cancer Hospital

Phase

Phase 2

Started

2024-02-10

Last updated

2024-02-01

Condition(s) studied

Small Cell Lung Carcinoma

Investigational drug(s) / intervention(s)

AdebrelimabRadiation Therapyetoposide, carboplatin(EC)

Adebrelimab: Etoposide 100mg/m2 day1-3+carboplatin AUC 5 day 1(EC) combined with Adebrelimab（ PD-L1 inhibitor）1200mg day1 Q3w for 2 cycles, and the efficacy is evaluated 3 weeks after the treatment. If the efficacy evaluation is SD/PR/CR, concurrent radiotherapy(45Gy /3Gy/qd/3w) with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy+ Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years.

Radiation Therapy: Etoposide 100mg/m2 day1-3+carboplatin AUC 5 day 1(EC) combined with Adebrelimab（ PD-L1 inhibitor）1200mg day1 Q3w for 2 cycles, and the efficacy is evaluated 3 weeks after the treatment. If the efficacy evaluation is SD/PR/CR, concurrent radiotherapy(45Gy /3Gy/qd/3w) with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy+ Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years.

etoposide, carboplatin(EC): Etoposide 100mg/m2 day1-3+carboplatin AUC 5 day 1(EC) combined with Adebrelimab（ PD-L1 inhibitor）1200mg day1 Q3w for 2 cycles, and the efficacy is evaluated 3 weeks after the treatment. If the efficacy evaluation is SD/PR/CR, concurrent radiotherapy(45Gy /3Gy/qd/3w) with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy+ Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years.

Study summary

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

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: 1. Aged 18-75 years; 2. Histologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system) ; 3. Must sign a written informed consent form prior to any study specific procedures; 4. No prior treatment for ES-SCLC; 5. No more than 5 lesions (including metastases),and at least one measurable lesion that meets RECIST 1.1 evaluation criteria; 6. Life expectancy more than 3 months; 7. ECOG PS 0-1 Exclusion Criteria: 1. Previous treatment with radiochemotherapy for limited-stage small cell lung cancer; 2. Subjects who previously received systemic antitumor or Immune checkpoint inhibitor therapy ; 3. 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; 4. Active brain metastases, Leptomeningeal metastasis(untreated central nervous system (CNS) metastases unless asymptomatic and lesion size\<1cm; 5. Patients with spinal cord compression; 6. Patients with multiple liver metastases(except isolated lesion and lesion size\<2cm); 7. 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; 8. The investigator judges that there are any patients who endanger the patient's safety, interfere with the study assessment, and have poor compliance.

Primary outcome measure(s)

6-m PFS rate — 6 months
6-m PFS rate is defined as the percentage of participants whose disease is still progression-free at the 6th month

Trial sites (2)

Facility	City	Region	Status
Henan Cancer Hospital	Zhengzhou	Henan
Tongji Hospital, Tongji Medical College，Huazhong University of Science and Technology	Wuhan	Hubei

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06236997 on ClinicalTrials.gov ↗ ← All trials in China