Maintenance Chemotherapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Chemotherapy for Stage IV Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II Trial

Inclusion Criteria

• •1. Patients must have biopsy proven metastatic NSCLC (Stage IV).
• •2. Patients must have received first line chemotherapy, from 4-6 cycles, and achieved stable disease or a partial response.
• •3. Patients receiving first-line erlotinib, crizotinib for EGFR mutant-positive or EML4-ALK positive NSCLC will be excluded.
• •4. Age ≥ 18 years
• •5. Patients must have measurable disease at baseline.
• •6. Patients can have up to only 6 discrete active extracranial lesions (≤3 in the liver and ≤3 in the lung) identified by diagnostic CT or PET/CT scan or MRI within 8 weeks prior to the initiation of SBRT.
• •1. For patients who have received prior radiotherapy to the primary site in the lung, residual PET activity is difficult to interpret and will not be considered a site of active disease if the CT appearance is stable or improved over an interval of at least three months
• •3. Patients with previously un-irradiated primary sites will be potentially eligible, but special considerations apply (section 4.3.2).
• •4. Up to 2 contiguous vertebral metastases will be considered a single site of disease.
• •7. Patients must have a KPS \>60
• •8. AST, ALT \& Alkaline phosphates must be ≤ 2.5X the upper limit of normal. Total bilirubin must be within the limit of normal.
• •9. Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm³.
• •10. Patients should have adequate renal function (serum creatinine ≤1.5 times the ULN).
• •11. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• •11.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• •* Has not undergone a hysterectomy or bilateral oophorectomy; or
• •* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
• •12. Patients who would be receiving SBRT for lung tumors who are known or suspected by the treating radiation oncologist to have compromised lung function must have a documented forced expiratory volume in 1 second (FEV1) ≥ 1L.
• •13. Patients must provide verbal and written informed consent to participate in the study.