SBRT Combined With Osimertinib Compared With Osimertinib for Stage IV NSCLC
Effect of SBRT Combined With Osimertinib Compared With Osimertinib Alone for Stage IV Non-small Cell Lung Cancer
1 other identifier
interventional
72
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2022
CompletedFirst Posted
Study publicly available on registry
October 17, 2022
CompletedStudy Start
First participant enrolled
January 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedOctober 17, 2022
October 1, 2022
2 years
October 12, 2022
October 13, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
PFS
the time from the beginning of Osimertinib treatment to disease progression or death
2 years
Secondary Outcomes (1)
OS
3 years
Study Arms (2)
Osimertinib plus SBRT
EXPERIMENTALSBRT with photon and dose is 40Gy/5F after three months after Osimertinib treatment
Osimertinib
ACTIVE COMPARATOROsimertinib 80mg, po, Qd
Interventions
Received SBRT after three months of Osimertinib treatment
Eligibility Criteria
You may qualify if:
- 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.
- \. 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.
You may not qualify if:
- Patients who previously received radiotherapy to the primary site.
- Patient can't tolerate radiotherapy or targeted therapy;
- Pregnant or nursing women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Li Zhanglead
- Hubei Cancer Hospitalcollaborator
Study Sites (1)
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 430030, Hubei, P. R. China
Wuhan, Hubei, 430030, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Li Zhang, MD,PhD
Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 12, 2022
First Posted
October 17, 2022
Study Start
January 1, 2023
Primary Completion
December 30, 2024
Study Completion
December 30, 2025
Last Updated
October 17, 2022
Record last verified: 2022-10