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Trial Title:
SBRT Combined With Osimertinib Compared With Osimertinib for Stage IV NSCLC
NCT ID:
NCT05583409
Condition:
Stage IV Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Osimertinib
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
SBRT plus Osimertinib versus Osimertinib
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
SBRT+Osimertinib
Description:
Received SBRT after three months of Osimertinib treatment
Arm group label:
Osimertinib plus SBRT
Intervention type:
Drug
Intervention name:
Osimertinib 80 MG
Description:
Osimertinib 80mg, po, Qd
Arm group label:
Osimertinib
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients must have biopsy proven metastatic NSCLC (Stage IV).
2. Patients receiving first-line Osimertinib for EGFR mutant-positive for 3 months and
achieved stable disease or partial response.
3. Age 18 to 75 years old.
4. Patients must have measurable disease at baseline.
5. The amount of metastatic focus <5.
6. 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:
1. Patients who previously received radiotherapy to the primary site.
2. Patient can't tolerate radiotherapy or targeted therapy;
3. Pregnant or nursing women
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 430030, Hubei, P. R. China
Address:
City:
Wuhan
Zip:
430030
Country:
China
Start date:
January 1, 2023
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Li Zhang
Agency class:
Other
Collaborator:
Agency:
Hubei Cancer Hospital
Agency class:
Other
Source:
Tongji Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05583409
