Stage IV Non-small Cell Lung Cancer
Conditions
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
Interventions
RADIATIONSBRT+Osimertinib
Received SBRT after three months of Osimertinib treatment
Osimertinib 80mg, po, Qd
Sponsors
Hubei Cancer Hospital
Li Zhang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
SBRT plus Osimertinib versus Osimertinib
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 2 years | the time from the beginning of Osimertinib treatment to disease progression or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | 3 years | the time from the beginning of Osimertinib treatment to death |
Countries
China
Contacts
Primary ContactLi Zhang, MD,PhD
Backup ContactPing Peng, PhD
Outcome results
None listed