NCT06125041

Adebelizumab Combined With Chemotherapy and Radiotherapy Treat ES-SCLC

A Single-arm, Multi-center and Exploratory Study of Adebelizumab Combined With Chemotherapy and Sequential Adebelizumab Combined With Radiotherapy in the Treatment of Newly Diagnosed Extensive Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Qianfoshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To observe the efficacy and safety of adebelizumab combined with chemotherapy and sequential adebelizumab combined with radiotherapy in the treatment of newly diagnosed extensive small cell lung cancer.

Detailed description

This study is a one-arm, multi-center and exploratory study. Eligible patients will receive the following treatment schemes: adebelizumab+carboplatin+etoposide, with one treatment cycle every three weeks. After 4-6 cycles, adebelizumab maintenance therapy combined with concurrent radiotherapy will be given, and conventional radiotherapy will be given to chest lesions (2Gy\*(20-30)f), brain (3Gy\*10f)/ bone (3Gy\*10f)/ adrenal gland. Immunotherapy is suspended during radiotherapy for chest lesions and lymph nodes in mediastinum, and immunotherapy is given 1-2 weeks after radiotherapy. Radiotherapy for other metastatic lesions can be carried out simultaneously with immunotherapy. Research population: patients with extensive small cell lung cancer diagnosed by histopathology or cytology, both male and female, aged 18-75 years old, who have not received systemic treatment for small cell lung cancer before. 51 patients are planned to be enrolled. Main research end point： PFS(RECIST v1.1 standard) evaluated by researchers. Secondary end point Key secondary study endpoints: The incidence of adverse reactions above grade 3 in patients evaluated according to CTCAE5.0 version 5.0. Other secondary study endpoints: OS； ORR(RECIST v1.1 standard) evaluated by researchers; DoR； evaluated by the researcher; DCR； assessed by the researcher; PFS rate at 6 months and 1 year OS rate at 1 year and 2 years. The end point of exploratory research Explore the biomarker related to curative effect.

Conditions

• Extensive Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Adebelizumab+Carboplatin+Etoposide+Concurrent Radiotherapy	Eligible patients will receive the following treatment schemes: adebelizumab+carboplatin+etoposide, with one treatment cycle every three weeks. After 4-6 cycles, adebelizumab maintenance therapy combined with concurrent radiotherapy will be given, and conventional radiotherapy will be given to chest lesions (2Gy\*(20-30)f), brain (3Gy\*10f)/ bone (3Gy\*10f)/ adrenal gland. Immunotherapy is suspended during radiotherapy for chest lesions and lymph nodes in mediastinum, and immunotherapy is given 1-2 weeks after radiotherapy. Radiotherapy for other metastatic lesions can be carried out simultaneously with immunotherapy.

Timeline

• Start date: 2023-10-30
• Primary completion: 2026-07-31
• Completion: 2026-12-31
• First posted: 2023-11-09
• Last updated: 2023-11-09

Locations

1 site across 1 country: China