Phase II Trial of Consolidative Thoracic Radiotherapy for ES-SCLC After Standard Care of Chemo-immunotherapy
Primary Purpose
Small-cell Lung Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
thoracic radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Small-cell Lung Cancer focused on measuring thoradic radiotherapy, immune checkpoint inhibitors, chemo-immunotherapy
Eligibility Criteria
Inclusion Criteria:
- Age between18 years and 80 years at time of study entry
- ECOG performance status of 0 or 1
- Body weight >30 kg
- Adequate bone marrow, liver and kidney function
- Life expectancy of at least 3 months
- At least one measurable (RECIST 1.1), thoracic lesion that can be irradiated with 45 Gy/15 fractions
- Histologic or cytologic confirmation of small cell lung cancer
- Stage III-IV disease (TNM v8)
- Adequate pulmonary function with FEV1 >1 L or >30 % of predicted value and DLCO >30 % of predicted value
- Patients with brain metastases are eligible provided they are asymptomatic or treated and stable on steroids and/or anticonvulsants prior to the start of treatment -
Exclusion Criteria:
- Previous chemo-, immuno- or radiotherapy for SCLC
- Major surgical procedure last 28 days
- History of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis or HIV
- Uncontrolled intercurrent illness
- Other active malignancy
- Leptomeningeal carcinomatosis
- Immunosuppressive medication
- Pregnant or breastfeeding women
Sites / Locations
- Ruijin Hospital, Shanghai jiaotong univestigy school of medicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
experimental group
Arm Description
chemo-immunotherapy followed by thoracic radiotherapy and PD-1/PD-L1 maintenance therapy
Outcomes
Primary Outcome Measures
1-year progression-free survival
PFS is defined as the period from the start of receiving the first EC/EP chemotherapy plus PD-1/PD-L1 inhibitor to disease progression.
Secondary Outcome Measures
1-year overall survival
toxicities
Number of participants with treatment-related adverse events and the grade of adverse events as assessed by CTCAE v4.0
5-year overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05552846
Brief Title
Phase II Trial of Consolidative Thoracic Radiotherapy for ES-SCLC After Standard Care of Chemo-immunotherapy
Official Title
Consolidative Thoracic Radiotherapy for Extensive-stage Small-cell Lung Cancer Treated With Chemo-immunotherapy Followed by PD-1/PD-L1 Maintenance Therapy:an Open Label, Single Arm Prospective Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2022 (Anticipated)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an open-label, single arm Phase II study designed to evaluate the efficacy and safety of thoracic radiotherapy for extensive-stage small-cell lung cancer treated with PD-1/PD-L1 plus etoposide platinum followed by PD-1/PD-L1 maintenance therapy
Detailed Description
This study a single arm prospective phase II study. All the enrolled patients will be patients with ES-SCLC who did not have PD (determined as per the RECIST v1.1) after 4 cycle of platinum-based chemotherapy in combination with an anti-PD-1/L1. Then, those enrolled patients would be treated with thoracic radiotherapy concurrently with PD-1/PD-L1 maintenance therapy, and the total maintenance therapy time should at least more than 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small-cell Lung Cancer
Keywords
thoradic radiotherapy, immune checkpoint inhibitors, chemo-immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
104 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
chemo-immunotherapy followed by thoracic radiotherapy and PD-1/PD-L1 maintenance therapy
Intervention Type
Radiation
Intervention Name(s)
thoracic radiotherapy
Intervention Description
Four courses of carboplatin/etoposide/anti-PD-1/PD-L1 every 3 weeks All the enrolled patients will be patients with ES-SCLC who did not have PD (determined as per the RECIST v1.1) after 4 cycle of platinum-based chemotherapy in combination with an anti-PD-1/L1. Then, thoracic radiotherapy of 45 Gy/15 fractions. PD-1/PD-L1 maintenance therapy concurrently and after thoracic radiotherapy at least more than 6 months, or until intolerable toxicity, progressive disease leading to a need for other treatment, or until the patient no longer wishes to continue treatment.
Primary Outcome Measure Information:
Title
1-year progression-free survival
Description
PFS is defined as the period from the start of receiving the first EC/EP chemotherapy plus PD-1/PD-L1 inhibitor to disease progression.
Time Frame
12 months after last patient entry
Secondary Outcome Measure Information:
Title
1-year overall survival
Time Frame
12 months after last patient entry
Title
toxicities
Description
Number of participants with treatment-related adverse events and the grade of adverse events as assessed by CTCAE v4.0
Time Frame
12 months after last patient entry
Title
5-year overall survival
Time Frame
5-year after last patient entry
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between18 years and 80 years at time of study entry
ECOG performance status of 0 or 1
Body weight >30 kg
Adequate bone marrow, liver and kidney function
Life expectancy of at least 3 months
At least one measurable (RECIST 1.1), thoracic lesion that can be irradiated with 45 Gy/15 fractions
Histologic or cytologic confirmation of small cell lung cancer
Stage III-IV disease (TNM v8)
Adequate pulmonary function with FEV1 >1 L or >30 % of predicted value and DLCO >30 % of predicted value
Patients with brain metastases are eligible provided they are asymptomatic or treated and stable on steroids and/or anticonvulsants prior to the start of treatment -
Exclusion Criteria:
Previous chemo-, immuno- or radiotherapy for SCLC
Major surgical procedure last 28 days
History of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis or HIV
Uncontrolled intercurrent illness
Other active malignancy
Leptomeningeal carcinomatosis
Immunosuppressive medication
Pregnant or breastfeeding women
Facility Information:
Facility Name
Ruijin Hospital, Shanghai jiaotong univestigy school of medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yifeng Wang
Phone
+862164370045
Email
qwx12055@rjh.com.cn
First Name & Middle Initial & Last Name & Degree
Yi Xiang, Dr.
First Name & Middle Initial & Last Name & Degree
Shengguang Zhao, Dr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Phase II Trial of Consolidative Thoracic Radiotherapy for ES-SCLC After Standard Care of Chemo-immunotherapy
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