Maintenance Targeted Therapy With or Without Stereotactic Body Radiation Therapy for Stage IV Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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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 a targeted agent such as gefitinib, erlotinib and icotinib.

Official Title
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Maintenance Targeted Therapy With or Without Stereotactic Body Radiation Therapy for Stage IV Non-small Cell Lung Cancer: a Prospective, Multicenter, Randomized Controlled Clinical Trial.

Conditions
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Stage IV Non-small Cell Lung Cancer

Intervention / Treatment
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* Radiation: SBRT+TKI
* Drug: TKI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have biopsy proven metastatic NSCLC (Stage IV). Patients must have received first line chemotherapy, from 4-6 cycles, and achieved stable disease or a partial response. Patients receiving first-line erlotinib, gefitinib, or icotinib for EGFR mutant-positive for 3 months and achieved stable disease, partial response or completely response. Age 18 to 75 years old. Patients must have measurable disease at baseline. The amount of metastatic focus <5. ECOG score 0-2 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) 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBRT plus TKI group<br>SBRT with photon and dose is 40-50Gy/5F after three months after EGFR-TKI treatment | Radiation: SBRT+TKI<br>* Received SBRT after three months after EGFR-TKI treatment<br>|
| Active Comparator: TKI treatment group<br>Standard EGFR-TKI(Gefitinib, erlotinib or icotinib) Gefitinib: 250mg po Qd Erlotinib: 150mg po Qd Icotinib: 125mg po tid | Drug: TKI<br>* Received EGFR-TKI treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression-free survival: From the first treatment to the date of first documentation of disease progression, or death due to any cause | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall survival: From the first administration to death from any cause | 3 year |