Study of Low-Dose Radiotherapy Concurrent Chemotherapy With Serplulimab for Patients With ES-SCLC
NCT ID: NCT05765825
Last Updated: 2024-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
61 participants
INTERVENTIONAL
2023-03-07
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
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).
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).
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).
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).
Interventions
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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.
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).
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).
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).
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Sichuan University
OTHER
Responsible Party
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You Lu
professor
Principal Investigators
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You Lu, MD
Role: STUDY_CHAIR
West China Hospital
Locations
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Chongqing University cancer hospital
Chongqing, Chongqing Municipality, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
LiaoNing Cancer Hospital & Institute
Shenyang, Liaoning, China
Shandong Provincial Hospital
Jinan, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
China West Hospital
Chengdu, Sichuan, China
GuiZhou Provincial People's Hospital
Guiyang, , China
Countries
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Central Contacts
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Facility Contacts
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Wei Zhou
Role: primary
Zhixiong Lin
Role: primary
Sheng Zhang
Role: primary
Deyu Sun
Role: primary
Zhe Yang
Role: primary
Weixin Zhao
Role: primary
Yu Zhang
Role: primary
Other Identifiers
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SPUR
Identifier Type: -
Identifier Source: org_study_id
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