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Administration regimen: adebelizumab 1200mg, IV, Q3W+ carboplatin AUC 5 d1+ etoposide 100mg/m2 D1, 2, 3; 21 days is a treatment cycle. After 4-6 cycles, patients with imaging evaluation CR/PR/SD (according to tumor RECIST1.1 standard) receive adebelizumab maintenance therapy and radiotherapy at the same time. Patients with imaging evaluation PD (according to tumor RECIST1.1 standard) can receive adebelizumab maintenance therapy combined with radiotherapy according to the clinical practice, or they can change other treatment schemes and continue to follow up.

After the induction treatment, the participants will continue to receive adebelizumab (20mg/kg, IV, Q3W) combined with concurrent radiotherapy (conventional radiotherapy SBRT chest lesions (2Gy\*25f), brain (3Gy\*10f)/ bone (3Gy\*10f)/ suprarenal gland (3Gy\*10-15f)/ liver (3YX).

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.

Adebelizumab+Carboplatin+Etoposide+Concurrent Radiotherapy

Jiandong Zhang

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.

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.

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

To explore the progression-free survival (PFS) and overall survival (OS) of patients with different types (SCLC-A/N/Y/P) of extensive small cell lung cancer treated by adebelizumab combined with chemotherapy and sequential adebelizumab combined with radiotherapy.

The time from the beginning of randomization to the occurrence (in any way) progression or death (for any reason) of a tumor.

Time from randomization to death (for any reason). For subjects who have been lost before death, the last follow-up time is usually calculated as the time of death.

The proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time limit is the sum of the proportion of complete remission and partial remission.

The percentage of cases with remission (PR+CR) and stable lesion (SD) after treatment to the evaluable cases.

Refers to the first evaluation of the tumor as CR or PR.

Spots Global Cancer Trial Database for adebelizumab+carboplatin+etoposide+concurrent radiotherapy