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

Summary

This study is a two-arm randomized phase ii trial. all patients enrolled on the trial will have received 4-6 cycles of first line chemotherapy. Patients with non-squamous histology may have the addition of bevacizumab to first-line therapy at the medical oncologist's discretion. Patients receiving first-line erlotinib, gefitinib, or crizotinib for eGFR mutant-positive or eML4-aLK positive nSCLC will be excluded. Patients will be assessed within 42 days following completion of first line chemotherapy with repeat diagnostic CT or PeT/CT. Patients with stable disease or partial response with oligometastatic disease, defined by six or fewer sites amenable to SBRT, will be randomized within 21 days of imaging either maintenance chemotherapy alone or SBRT to all gross disease followed by maintenance chemotherapy. SBRT will be given according to guidelines outlined in Section 4. Maintenance chemotherapy will continue until disease progression, intolerable toxicity, or death.

Participant Eligibility

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, gefitinib, or 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.
a)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
b)Patients who previously received radiotherapy to the primary site will be ineligible if there is CT evidence of disease progression within the past 3 months.
c)Patients with previously un-irradiated primary sites will be potentially eligible, but special considerations apply (section 4.3.2).
d)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/mm[CUBED].
10.Patients should have adequate renal function (serum creatinine <=1.5 times the ULN).
11. Females of childbearing potential should have a negative pregnancy test.
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.