Phase II, Single-Arm Study of Low-Dose Radiotherapy (LDRT) Concurrent Cisplatin/Carboplatin Plus Etoposide With Serplulimab for Patients With Extensive-Stage Small Cell Lung Cancer

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a Phase II, single arm, multicenter study designed to evaluate the safety and efficacy of low-dose radiotherapy (LDRT) concurrent cisplatin/carboplatin plus etoposide with serplulimab in participants who have extensive-stage small cell lung cancer (ES-SCLC) and are chemotherapy-navïe for their extensive-stage disease.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically or cytologically confirmed ES-SCLC

• No prior treatment for ES-SCLC

• Measurable disease, as defined by RECIST v1.1. Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation.

• ECOG performance status of 0 or 1

• Life expectancy \>= 3 months

• Adequate hematologic and end-organ function

• For participants receiving therapeutic anticoagulation: stable anticoagulant regimen

• Negative human immunodeficiency virus (HIV) test at screening

• Negative hepatitis B surface antigen (HBsAg) test at screening

⁃ Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following: Negative total hepatitis B core antibody (HBcAb), or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test. The HBV DNA test will be performed only for participants who have a negative HBsAg test, a negative HBsAb test, and a positive total HBcAb test.

⁃ Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed only for participants who have a positive HCV antibody test.

⁃ For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception

⁃ For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm

Locations
Other Locations
China
China West Hospital
RECRUITING
Chengdu
Chongqing University cancer hospital
RECRUITING
Chongqing
GuiZhou Provincial People's Hospital
RECRUITING
Guiyang
Shandong Provincial Hospital
RECRUITING
Jinan
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Cancer Hospital of Shantou University Medical College
RECRUITING
Shantou
LiaoNing Cancer Hospital & Institute
RECRUITING
Shenyang
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Contact Information
Primary
Zhuoran Yao, MD
yaozhuoran@outlook.com
13261660839
Backup
Li Li, BA
tracy.li_2010@hotmail.com
02885424619
Time Frame
Start Date: 2023-03-07
Estimated Completion Date: 2025-12
Participants
Target number of participants: 61
Treatments
Experimental: LDRT concurrent cisplatin/carboplatin + etoposide + serplulimab
Participants will receive the following treatment regimens: The induction period consists of 4 cycles of 21 days each. Low-dose radiotherapy(LDRT) at 15Gy/5f will be performed concurrently from Day 1 to Day 5 (D1-D5) of Cycle 1. An efficacy assessment will be performed at the end of Cycle 2. For patients with primary lung lesions (intrathoracic lesions) evaluated as small PR (tumor shrinkage \< 80%)/SD/PD, ldrt at 15Gy/5f will be performed in addition to serplulimab with chemotherapy in Cycle 3. For subjects evaluated as PD/SD/PR with extrathoracic residual metastases, ldrt at 15Gy/5f will be performed in addition to serplulimab with chemotherapy in Cycle 4. After the induction period, the subjects will continue to receive maintenance treatment with serplulimab.
Sponsors
Leads: Sichuan University

This content was sourced from clinicaltrials.gov