Back to resultsSBRT Combined With Osimertinib Compared With Osimertinib for Stage IV NSCLC
Primary Purpose
Stage IV Non-small Cell Lung Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SBRT+Osimertinib
Osimertinib 80 MG
Sponsored by
About this trial
This is an interventional treatment trial for Stage IV Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients must have biopsy proven metastatic NSCLC (Stage IV).
- Patients receiving first-line Osimertinib for EGFR mutant-positive for 3 months and achieved stable disease or partial response.
- Age 18 to 75 years old.
- Patients must have measurable disease at baseline.
- The amount of metastatic focus <5.
- ECOG score 0-2 7 Adequate normal organ and marrow function for TKI treatment and radiotherapy.
8. Patients must has sensitizing EGFR mutation (e.g. exon 19 deletion or exon 21 L858R) 9. Patients must provide written informed consent to participate in the study.
Exclusion Criteria:
- Patients who previously received radiotherapy to the primary site.
- Patient can't tolerate radiotherapy or targeted therapy;
- Pregnant or nursing women
Sites / Locations
- Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 430030, Hubei, P. R. China
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Osimertinib plus SBRT
Osimertinib
Arm Description
SBRT with photon and dose is 40Gy/5F after three months after Osimertinib treatment
Osimertinib 80mg, po, Qd
Outcomes
Primary Outcome Measures
PFS
the time from the beginning of Osimertinib treatment to disease progression or death
Secondary Outcome Measures
OS
the time from the beginning of Osimertinib treatment to death
Full Information
NCT ID
NCT05583409
First Posted
October 12, 2022
Last Updated
October 13, 2022
Sponsor
Li Zhang
Collaborators
Hubei Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05583409
Brief Title
SBRT Combined With Osimertinib Compared With Osimertinib for Stage IV NSCLC
Official Title
Effect of SBRT Combined With Osimertinib Compared With Osimertinib Alone for Stage IV Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Li Zhang
Collaborators
Hubei Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a Prospective, Multicenter, Randomized Controlled study to evaluate Stereotactic Body Radiation Therapy (SBRT) as a potential treatment for stage IV non-small cell lung cancer (NSCLC) that has a mutated epidermal growth factor receptor (EGFR) and has been receiving treatment with Osimertinib
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
SBRT plus Osimertinib versus Osimertinib
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Osimertinib plus SBRT
Arm Type
Experimental
Arm Description
SBRT with photon and dose is 40Gy/5F after three months after Osimertinib treatment
Arm Title
Osimertinib
Arm Type
Active Comparator
Arm Description
Osimertinib 80mg, po, Qd
Intervention Type
Radiation
Intervention Name(s)
SBRT+Osimertinib
Intervention Description
Received SBRT after three months of Osimertinib treatment
Intervention Type
Drug
Intervention Name(s)
Osimertinib 80 MG
Intervention Description
Osimertinib 80mg, po, Qd
Primary Outcome Measure Information:
Title
PFS
Description
the time from the beginning of Osimertinib treatment to disease progression or death
Time Frame
2 years
Secondary Outcome Measure Information:
Title
OS
Description
the time from the beginning of Osimertinib treatment to death
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have biopsy proven metastatic NSCLC (Stage IV).
Patients receiving first-line Osimertinib for EGFR mutant-positive for 3 months and achieved stable disease or partial response.
Age 18 to 75 years old.
Patients must have measurable disease at baseline.
The amount of metastatic focus <5.
ECOG score 0-2 7 Adequate normal organ and marrow function for TKI treatment and radiotherapy.
8. Patients must has sensitizing EGFR mutation (e.g. exon 19 deletion or exon 21 L858R) 9. Patients must provide written informed consent to participate in the study.
Exclusion Criteria:
Patients who previously received radiotherapy to the primary site.
Patient can't tolerate radiotherapy or targeted therapy;
Pregnant or nursing women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Zhang, MD,PhD
Phone
02783663407
Email
luzigang@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ping Peng, PhD
Phone
02783663407
Email
pengpingtj@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Zhang, MD,PhD
Organizational Affiliation
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 430030, Hubei, P. R. China
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
12. IPD Sharing Statement
Learn more about this trial
SBRT Combined With Osimertinib Compared With Osimertinib for Stage IV NSCLC
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