Trial Title:
Study of Low-Dose Radiotherapy Concurrent Chemotherapy With Serplulimab for Patients With ES-SCLC
NCT ID:
NCT05765825
Condition:
Extensive-stage Small-cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Cisplatin
Carboplatin
Etoposide
Etoposide phosphate
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
serplulimab
Description:
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.
Arm group label:
LDRT concurrent cisplatin/carboplatin + etoposide + serplulimab
Other name:
HLX10
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
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).
Arm group label:
LDRT concurrent cisplatin/carboplatin + etoposide + serplulimab
Other name:
Cisplatin injection
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
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).
Arm group label:
LDRT concurrent cisplatin/carboplatin + etoposide + serplulimab
Other name:
Carboplatin injection
Intervention type:
Drug
Intervention name:
Etoposide
Description:
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).
Arm group label:
LDRT concurrent cisplatin/carboplatin + etoposide + serplulimab
Other name:
Etoposide injection
Intervention type:
Radiation
Intervention name:
Thoracic radiation therapy (TRT)
Description:
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).
Arm group label:
LDRT concurrent cisplatin/carboplatin + etoposide + serplulimab
Other name:
low-dose radiotherapy
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.
Detailed description:
Enrolled patients will receive the following treatment regimen: LDRT-concurrent
cisplatin/carboplatin plus etoposide in combination with serplulimab. The induction
period consists of 4 cycles of 21 days each. Low-dose radiotherapy 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 and one week before the start of Cycle 3. For
patients with primary lung lesions (intrathoracic lesions) evaluated as small PR (tumor
shrinkage < 80%)/SD/PD, low-dose radiotherapy 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, low-dose radiotherapy at 15Gy/5f will be performed in
addition to serplulimab with chemotherapy in Cycle 4. Definition of extrathoracic lesions
for radiotherapy: Metastases to liver, metastases to adrenals and metastases to lymph
nodes (at the discretion of the investigator).
After the induction period, the subjects will continue to receive maintenance treatment
with serplulimab. Prophylactic cranial irradiation (PCI) is allowed for treatment
according to local standard of care. Patients will be treated until loss of clinical
benefit, unacceptable toxicity, withdrawal of informed consent, or death, whichever
occurs first.
Criteria for eligibility:
Criteria:
Main Inclusion Criteria:
1. Histologically or cytologically confirmed ES-SCLC
2. No prior treatment for ES-SCLC
3. 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.
4. ECOG performance status of 0 or 1
5. Life expectancy >= 3 months
6. Adequate hematologic and end-organ function
7. For participants receiving therapeutic anticoagulation: stable anticoagulant regimen
8. Negative human immunodeficiency virus (HIV) test at screening
9. Negative hepatitis B surface antigen (HBsAg) test at screening
10. 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.
11. 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.
12. For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraception
13. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or
use a condom, and agreement to refrain from donating sperm
Main Exclusion Criteria:
1. Symptomatic, untreated, or actively progressing central nervous system (CNS)
metastases
2. Participants with pulmonary artery invasion
3. History of leptomeningeal disease
4. Uncontrolled tumor-related pain
5. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent
drainage procedures
6. Uncontrolled or symptomatic hypercalcemia
7. Active or history of autoimmune disease or immune deficiency
8. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on
screening chest computed tomography (CT) scan
9. Active tuberculosis
10. Significant cardiovascular disease within 3 months prior to initiation of study
treatment, unstable arrhythmia, or unstable angina
11. History of malignancy other than small cell lung cancer (SCLC) within 5 years prior
to screening, with the exception of malignancies with a negligible risk of
metastasis or death
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chongqing University cancer hospital
Address:
City:
Chongqing
Zip:
400030
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Zhou
Facility:
Name:
Cancer Hospital of Shantou University Medical College
Address:
City:
Shantou
Zip:
515041
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhixiong Lin
Facility:
Name:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Recruiting
Contact:
Last name:
Sheng Zhang
Facility:
Name:
LiaoNing Cancer Hospital & Institute
Address:
City:
Shenyang
Zip:
110801
Country:
China
Status:
Recruiting
Contact:
Last name:
Deyu Sun
Facility:
Name:
Shandong Provincial Hospital
Address:
City:
Jinan
Zip:
250021
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhe Yang
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Weixin Zhao
Facility:
Name:
China West Hospital
Address:
City:
Chengdu
Zip:
610000
Country:
China
Status:
Recruiting
Contact:
Last name:
You Lu, MD
Phone:
00862885423571
Email:
radyoulu@hotmail.com
Contact backup:
Last name:
Zhuoran Yao, MD
Phone:
13261660839
Email:
yaozhuoran@outlook.com
Facility:
Name:
GuiZhou Provincial People's Hospital
Address:
City:
Guiyang
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu Zhang
Start date:
March 7, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
Sichuan University
Agency class:
Other
Source:
Sichuan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05765825
