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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05583409
Other study ID # TJCC-LC002
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date December 30, 2025

Study information

Verified date October 2022
Source Tongji Hospital
Contact Li Zhang, MD,PhD
Phone 02783663407
Email luzigang@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 72
Est. completion date December 30, 2025
Est. primary completion date December 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
SBRT+Osimertinib
Received SBRT after three months of Osimertinib treatment
Drug:
Osimertinib 80 MG
Osimertinib 80mg, po, Qd

Locations

Country Name City State
China Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 430030, Hubei, P. R. China Wuhan Hubei

Sponsors (2)

Lead Sponsor Collaborator
Li Zhang Hubei Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary PFS the time from the beginning of Osimertinib treatment to disease progression or death 2 years
Secondary OS the time from the beginning of Osimertinib treatment to death 3 years
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