Back to resultsSRS Sequential Sindilimab in Brain Metastasis of NSLSC
Primary Purpose
NSCLC Stage IV, Brain Metastases, SRS
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SRS sequential sintilimab
Sponsored by
About this trial
This is an interventional treatment trial for NSCLC Stage IV
Eligibility Criteria
Inclusion Criteria:
- non-small cell lung cancer patients with less than brain metastases
- Patients must have received at least the first-line anti-tumor treatment, and the front-line treatment must include chemotherapy or targeted treatment with a platinum containing combination scheme, but not anti-PD-1 / L1 treatment
- Patients who have not received intracranial local treatment before
Exclusion Criteria:
- Patients who toke major surgery within 4 weeks prior to enrollment or had ununited wounds
- Patients with hemorrhage in intracranial metastasis
Sites / Locations
- Union hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SRS sequential sintilimab
Arm Description
Outcomes
Primary Outcome Measures
iPFSof NSCLC patients receiving SRS sequential sintilimab
From the beginning of treatment to the end of follow-up study, when the longest diameter of brain metastases treated by SRS was more than 30% smaller than the baseline level at any time of efficacy evaluation, the objective remission of the lesions was achieved. The time from the objective remission to the next progress of the intracranial lesions was recorded as the intracranial progression-free survival(iPFS).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04180501
Brief Title
SRS Sequential Sindilimab in Brain Metastasis of NSLSC
Official Title
A Phase II Study on the Treatment of Advanced Non-small Cell Lung Cancer With Brain Metastasis by SRS Sequential Sintilimab
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2019 (Anticipated)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiaorong Dong
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
A phase II study on the treatment of advanced non-small cell lung cancer with brain metastasis by SRS sequential sintilimab
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSCLC Stage IV, Brain Metastases, SRS, Sintilimab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SRS sequential sintilimab
Arm Type
Experimental
Intervention Type
Combination Product
Intervention Name(s)
SRS sequential sintilimab
Intervention Description
The subjects first received a targeted radiotherapy of SRS, and started the treatment of sintilimab per 3 weeks within 35 days after SRS.
Primary Outcome Measure Information:
Title
iPFSof NSCLC patients receiving SRS sequential sintilimab
Description
From the beginning of treatment to the end of follow-up study, when the longest diameter of brain metastases treated by SRS was more than 30% smaller than the baseline level at any time of efficacy evaluation, the objective remission of the lesions was achieved. The time from the objective remission to the next progress of the intracranial lesions was recorded as the intracranial progression-free survival(iPFS).
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
non-small cell lung cancer patients with less than brain metastases
Patients must have received at least the first-line anti-tumor treatment, and the front-line treatment must include chemotherapy or targeted treatment with a platinum containing combination scheme, but not anti-PD-1 / L1 treatment
Patients who have not received intracranial local treatment before
Exclusion Criteria:
Patients who toke major surgery within 4 weeks prior to enrollment or had ununited wounds
Patients with hemorrhage in intracranial metastasis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiaorong dong, Dr
Phone
15071116896
Email
zrg27@163.com
Facility Information:
Facility Name
Union hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
dong xiaorong, Dr
12. IPD Sharing Statement
Learn more about this trial
SRS Sequential Sindilimab in Brain Metastasis of NSLSC
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