SBRT/RT in Oligometastatic Stage IV NSCLC

The core hypothesis to be tested is that the use of consolidative SBRT followed by maintenance chemotherapy in patients with less than or equal to 10 metastatic sites will improve progression-free survival (PFS) with acceptable toxicity compared to maintenance chemotherapy alone.

Inclusion Criteria:Patients must have biopsy-proven metastatic NSCLC (Stage IV).Patients must have received three months of first-line chemotherapy and achieved stable disease or partial response.Age ≥ 18 yearsPatients must have measurable disease at baseline.Patients can have up to 10 discrete active extracranial/intracranial lesions identified by PET/CT or MRI scan within 8 weeks prior to the initiation of SBRT.Patients must have a Karnofsky Performance Scale (KPS) >60AST, ALT & Alkaline phosphates must be ≤ 2.5x the upper limit of normal. Total bilirubin must be within the limit of normal.Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm³.Patients should have adequate renal function (serum creatinine ≤1.5 times the upper limit of normal (ULN).Females of childbearing potential should have a negative pregnancy test.Patients who would be receiving SBRT for lung tumors must have a documented forced expiratory volume in 1 second (FEV1) ≥ 1L.Patients must provide verbal and written informed consent to participate in the studyExclusion Criteria:Patients receiving first-line erlotinib, gefitinib, or crizotinib for EGFR mutant-positive or EML4-ALK-positive NSCLC will be excluded.Patients who previously received radiotherapy at the primary site with CT evidence of disease progression at the primary site within 3 months following the initial radiotherapyPatients with serious, uncontrolled, concurrent infection(s)Significant weight loss (>10%) in the prior 3 monthsPatients with cutaneous metastasis of NSCLCTreatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cancersPatients with more than 10 discrete extra/intracranial lesionsParticipation in any investigational drug study within 4 weeks preceding the start of study treatmentUnwillingness to participate or inability to comply with the protocol for the duration of the studyPatients who are pregnant; patients with reproductive capability will need to use adequate contraception during the time of participation in the study