Study of Low-Dose Radiotherapy Concurrent Chemotherapy With Serplulimab for Patients With ES-SCLC

PHASE2RecruitingINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

March 7, 2023

Primary Completion Date

June 30, 2024

Study Completion Date

December 31, 2025

Conditions
Extensive-stage Small-cell Lung Cancer
Interventions
DRUG

serplulimab

Serplulimab will be administered by intravenous infusion at a dose of 4.5mg/kg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, and clinical status.

DRUG

Cisplatin

Cisplatin will be administered as intravenous infusion at a dose of 75 mg per meter squared (75 mg/m\^2) after completion of serplulimab on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).

DRUG

Carboplatin

Carboplatin will be administered as intravenous infusion at a dose of area under the concentration-time curve (AUC) of 5 mg/mL/min on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).

DRUG

Etoposide

Etoposide will be administered intravenously at a dose of 100 mg/m\^2 on Days 1, 2 and 3 of each 21-day cycle during the induction phase (Cycles 1-4).

RADIATION

Thoracic radiation therapy (TRT)

Participants will receive concurrent low-dose radiotherapy treatment, in once daily fractions, 3 Gy per fraction, to a target dose of 15 Gy in 5 fractions from Day 1-Day 5 in the first cycle, third cycle( For patients with primary lung lesions (intrathoracic lesions) evaluated as small PR (tumor shrinkage \< 80%)/SD/PD),forth cycle(for subjects evaluated as PD/SD/PR with extrathoracic residual metastases).

Trial Locations (8)

110801

RECRUITING

LiaoNing Cancer Hospital & Institute, Shenyang

200032

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

250021

RECRUITING

Shandong Provincial Hospital, Jinan

400030

RECRUITING

Chongqing University cancer hospital, Chongqing

430022

RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan

515041

RECRUITING

Cancer Hospital of Shantou University Medical College, Shantou

610000

RECRUITING

China West Hospital, Chengdu

Unknown

RECRUITING

GuiZhou Provincial People's Hospital, Guiyang

All Listed Sponsors
lead

Sichuan University

OTHER