A Randomized Phase II Study of Oligometastatic Stage IV Non-Small Cell Lung Cancer (NSCLC) Treated With Systemic Therapy Plus Either Radiotherapy to All Sites of Gross Residual Disease or No Radiotherapy

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

- Mixed histology allowed if all components are consistent with NSCLC

- Squamous cell histology allowed

- Stage IV disease

- Oligometastatic disease (M1 with 1-3 metastases)

- Patients with M1 disease that involves intrapulmonary metastases are
eligible provided ≤ 40% of the total lung volume receives ≥ 20 Gy of
radiotherapy

- Previously untreated disease OR achieved stable disease or partial response within 8
weeks after completion of 2-6 courses of standard platinum-based chemotherapy
(administered every 3-4 weeks)

- Pleural effusion allowed provided it is minimal

- No history of or current brain metastases

- Patients who have had up to 3 brain metastases allowed provided they have been
treated with not signs of progression

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Life expectancy ≥ 12 weeks

- Platelet count ≥ 100,00/mm^3

- Hemoglobin ≥ 9 g/dL

- WBC ≥ 2,000/mm^3

- Creatinine ≤ 2 times upper limit of normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to undergo radiotherapy, based on radiation oncology consultation

- Willing and able to comply with study treatment

- FEV_1 ≥ 1 L

- No requirement for daily supplemental oxygen

- No second primary malignancy, except for any of the following:

- Carcinoma in situ of the cervix

- Nonmelanoma skin cancer

- History of low-grade (Gleason score ≤ 6) localized prostate cancer, even if
diagnosed within the past 5 years

- Stage I breast cancer that was treated within the past 5 years

- Other malignancy that was diagnosed and definitely treated ≥ 5 years ago with no
subsequent evidence of recurrence

- No concurrent severe and/or uncontrolled medical condition, including any of the
following:

- Angina pectoris

- Congestive heart failure within the past 3 months, unless LVEF > 40%

- Myocardial infarction within the past 6 months

- Cardiac arrhythmia

- No clinically significant infection

- No psychiatric illness or social situation that would limit compliance with study
requirements

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior therapy for this cancer other than 2-6 courses of standard platinum-based
chemotherapy with or without bevacizumab

- No prior radiotherapy to the treatment sites (e.g., primary lesion, clinically
involved nodes, or metastatic lesions)

- No bevacizumab during and for 4 weeks after completion of radiotherapy

- No concurrent systemic chemotherapy

- No other maintenance systemic therapy during radiotherapy

- No other concurrent investigational agents for the primary neoplasm

- No concurrent intensity modulated radiotherapy

- No concurrent prophylactic nodal radiotherapy