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Clinical Trial NCT05765825 for Extensive-stage Small-cell Lung Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Study of Low-Dose Radiotherapy Concurrent Chemotherapy With Serplulimab for Patients With ES-SCLC Phase 2 61

Recruiting
Clinical Trial NCT05765825 is designed to study Treatment for Extensive-stage Small-cell Lung Cancer. It is a Phase 2 interventional study that is recruiting, having started on March 7, 2023, with plans to enroll 61 participants. Led by Sichuan University, it is expected to complete by December 1, 2025. The latest data from ClinicalTrials.gov was last updated on June 20, 2024.
Brief 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. Fo...Show More
Official Title

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

Conditions
Extensive-stage Small-cell Lung Cancer
Other Study IDs
  • SPUR
NCT ID Number
NCT05765825
Start Date (Actual)
2023-03-07
Last Update Posted
2024-06-20
Completion Date (Estimated)
2025-12
Enrollment (Estimated)
61
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalLDRT 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 15...Show More
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).
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Progression-free survival (PFS)
The time from the date of first dosing of serplulimab to the first appearance of objective disease progression (according to RECIST1.1) or death from any cause (if it occurs before disease progression).
Baseline up to approximately 24 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
PFS Rate at 6 Months and 1 Year
PFS rate at 6 months and 1 year, defined as the proportion of patients who have not experienced disease progression or death from any cause at 6 months and 1 year separately, as determined by the investigator according to RECIST v1.1.
Baseline up to 1 year
Overall Survival (OS)
The time from the date of first dosing of serplulimab to death from any cause.
Baseline up to approximately 24 months
OS Rate at 1 Year and 2 Years
OS rate at 1 year and 2 years, defined as the proportion of patients who have not experienced death from any cause at 1 year and 2 years.
Baseline to 2 years or death, whichever occurs first.
Duration of response (DOR)
defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.
Baseline to disease progression or death from any cause (whichever occurs first)(up to approximately 24 months)
Disease control rate (DCR)
defined as the proportion of participants who have a best overall response of CR or PR or stable disease (SD), as determined by the investigator according to RECIST v1.1.
Baseline up to approximately 24 months
Percentage of Participants With Adverse Event
• The incidence and severity of adverse events, with severity determined according to the U.S. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0 (CTCAEv5.0)
Baseline up to approximately 36 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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

  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
Sichuan University logoSichuan University
Study Responsible Party
You Lu, Principal Investigator, professor, Sichuan University
Study Central Contact
Contact: Zhuoran Yao, MD, 13261660839, [email protected]
Contact: Li Li, BA, 02885424619, [email protected]
8 Study Locations in 1 Countries

Chongqing Municipality

Chongqing University cancer hospital, Chongqing, Chongqing Municipality, 400030, China
Wei Zhou, Contact
Recruiting

Guangdong

Cancer Hospital of Shantou University Medical College, Shantou, Guangdong, 515041, China
Zhixiong Lin, Contact
Recruiting

Hubei

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430022, China
Sheng Zhang, Contact
Recruiting

Liaoning

LiaoNing Cancer Hospital & Institute, Shenyang, Liaoning, 110801, China
Deyu Sun, Contact
Recruiting

Shandong

Shandong Provincial Hospital, Jinan, Shandong, 250021, China
Zhe Yang, Contact
Recruiting

Shanghai Municipality

Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality, 200032, China
Weixin Zhao, Contact
Recruiting

Sichuan

China West Hospital, Chengdu, Sichuan, 610000, China
You Lu, MD, Contact, 00862885423571, [email protected]
Zhuoran Yao, MD, Contact, 13261660839, [email protected]
Recruiting
GuiZhou Provincial People's Hospital, Guiyang, China
Yu Zhang, Contact
Recruiting