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Study of Low-Dose Radiotherapy Concurrent Cisplatin/Carboplatin Plus Etoposide With Serplulimab for Patients With ES-SCLC

Primary Purpose

Extensive-stage Small-cell Lung Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
serplulimab
Cisplatin
Carboplatin
Etoposide
Thoracic radiation therapy (TRT)
Sponsored by
Sichuan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extensive-stage Small-cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria: 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 Main Exclusion Criteria: Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases Participants with pulmonary artery invasion History of leptomeningeal disease Uncontrolled tumor-related pain Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures Uncontrolled or symptomatic hypercalcemia Active or history of autoimmune disease or immune deficiency 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 Active tuberculosis Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina 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

Sites / Locations

  • Cancer Hospital of Shantou University Medical College
  • The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • LiaoNing Cancer Hospital & Institute
  • Shandong Provincial Hospital
  • Fudan University Shanghai Cancer Center
  • China West Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LDRT concurrent cisplatin/carboplatin + etoposide + serplulimab

Arm Description

Participants will receive the following treatment regimens: LDRT concurrent cisplatin/carboplatin + etoposide + serplulimab. Induction treatment will be administered on a 21-day cycle for four cycles. Concurrent radiation therapy will be conducted from Day 1 - Day 5 in the first cycle. Following the induction phase, participants will continue maintenance therapy with serplulimab and thoracic radiation therapy (30Gay/10f). Participants will be treated until loss of clinical benefit, or unaccepted toxicity, or withdrawal of consent, or death (whichever occurs first).

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)
The time from the date of first dosing of durvalumab to the first appearance of objective disease progression (according to RECIST1.1) or death from any cause (if it occurs before disease progression).

Secondary Outcome Measures

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.
Overall Survival (OS)
OS, defined as the time from initiation of study treatment to death from any cause.
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.
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.
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.
Percentage of Participants With Adverse Event

Full Information

First Posted
March 1, 2023
Last Updated
March 1, 2023
Sponsor
Sichuan University
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1. Study Identification

Unique Protocol Identification Number
NCT05765825
Brief Title
Study of Low-Dose Radiotherapy Concurrent Cisplatin/Carboplatin Plus Etoposide With Serplulimab for Patients With ES-SCLC
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 25, 2023 (Anticipated)
Primary Completion Date
March 25, 2024 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sichuan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extensive-stage Small-cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LDRT concurrent cisplatin/carboplatin + etoposide + serplulimab
Arm Type
Experimental
Arm Description
Participants will receive the following treatment regimens: LDRT concurrent cisplatin/carboplatin + etoposide + serplulimab. Induction treatment will be administered on a 21-day cycle for four cycles. Concurrent radiation therapy will be conducted from Day 1 - Day 5 in the first cycle. Following the induction phase, participants will continue maintenance therapy with serplulimab and thoracic radiation therapy (30Gay/10f). Participants will be treated until loss of clinical benefit, or unaccepted toxicity, or withdrawal of consent, or death (whichever occurs first).
Intervention Type
Drug
Intervention Name(s)
serplulimab
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention 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).
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention 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).
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention 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).
Intervention Type
Radiation
Intervention Name(s)
Thoracic radiation therapy (TRT)
Intervention Description
Participants will receive concurrent thoracic radiation therapy (TRT) 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.Following the induction phase, participants will continue maintenance therapy with serplulimab thoracic radiation therapy (TRT) treatment, in once daily fractions, 3 Gy per fraction, to a target dose of 30 Gy in 10 fractions in the fifth and sixth cycle
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
The time from the date of first dosing of durvalumab to the first appearance of objective disease progression (according to RECIST1.1) or death from any cause (if it occurs before disease progression).
Time Frame
Baseline up to approximately 24 months
Secondary Outcome Measure Information:
Title
PFS Rate at 6 Months and 1 Year
Description
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.
Time Frame
Baseline up to 1 year
Title
Overall Survival (OS)
Description
OS, defined as the time from initiation of study treatment to death from any cause.
Time Frame
Baseline up to approximately 24 months
Title
OS Rate at 1 Year and 2 Years
Description
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.
Time Frame
Baseline to 2 years or death, whichever occurs first.
Title
Duration of response (DOR)
Description
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.
Time Frame
Baseline to disease progression or death from any cause (whichever occurs first)(up to approximately 24 months)
Title
Disease control rate (DCR)
Description
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.
Time Frame
Baseline up to approximately 24 months
Title
Percentage of Participants With Adverse Event
Time Frame
Baseline up to approximately 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: 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 Main Exclusion Criteria: Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases Participants with pulmonary artery invasion History of leptomeningeal disease Uncontrolled tumor-related pain Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures Uncontrolled or symptomatic hypercalcemia Active or history of autoimmune disease or immune deficiency 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 Active tuberculosis Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhuoran Yao, MD
Phone
13261660839
Email
yaozhuoran@outlook.com
First Name & Middle Initial & Last Name or Official Title & Degree
Li Li, BA
Phone
02885424619
Email
tracy.li_2010@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
You Lu, MD
Organizational Affiliation
West China Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Hospital of Shantou University Medical College
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515041
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhixiong Lin
Facility Name
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
City
Guangzhou
State/Province
GuangGong
ZIP/Postal Code
510405
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LIzhu Lin
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng Zhang
Facility Name
LiaoNing Cancer Hospital & Institute
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110801
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deyu Sun
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250021
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhe Yang
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weixin Zhao
Facility Name
China West Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
You Lu, MD
Phone
00862885423571
Email
radyoulu@hotmail.com
First Name & Middle Initial & Last Name & Degree
Zhuoran Yao, MD
Phone
13261660839
Email
yaozhuoran@outlook.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of Low-Dose Radiotherapy Concurrent Cisplatin/Carboplatin Plus Etoposide With Serplulimab for Patients With ES-SCLC

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