Specialized Radiation Therapy and Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

PRIMARY OBJECTIVES:

I. To determine the maximum-tolerable radiotherapy (RT) dose fraction for accelerated
hypofractionated radiotherapy with concurrent chemotherapy.

SECONDARY OBJECTIVES:

I. To evaluate the rate of radiographic response to treatment. II. To estimate the rates of
progression: local/regional/distant. III. To estimate the progression-free survival. IV. To
estimate the overall survival.

OUTLINE: This is a dose-escalation study of accelerated hypofractionated radiotherapy.

CONCURRENT THERAPY: Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30-60
minutes on days 1 and 8. Treatment repeats every 14 days for 2 courses in the absence of
disease progression or unacceptable toxicity. Patients also undergo accelerated
hypofractionated radiotherapy using 3-dimensional conformal radiation therapy or
intensity-modulated radiotherapy (IMRT) once daily, 5 days a week, for approximately 4-5.5
weeks.

CONSOLIDATION THERAPY: Beginning 4 weeks after completion of radiotherapy, patients receive
paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats
every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1 month, every 3 months for
2 years, and then every 6 months for 3 years.

1. Histologically or cytologically documented non-small cell lung cancer

2. Stage IIIA or IIIB non-small cell lung cancer (NSCLC) per American Joint Committee on
Cancer (AJCC) version 7; patients who present with N2 or N3 disease and an
undetectable primary tumor are also eligible

3. Thoracic disease without supraclavicular or contralateral hilar involvement

4. When pleural fluid is visible on both computed tomography (CT) scan and on a chest
x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically
negative; exudative pleural effusions are excluded regardless of cytology; patients
with effusions that are minimal (i.e., not visible on chest x-ray) and too small to
safely tap are eligible

5. No prior radiotherapy or chemotherapy for NSCLC

6. No prior mediastinal or thoracic radiotherapy

7. Patients with complete surgical resection of disease are not eligible, however;
patients with surgical resection and measurable gross residual disease present on
imaging are considered eligible

8. Patients must have measurable disease

- Lesions that can be accurately measured in at least one dimension (longest
diameter to be recorded) as >= 2 cm with conventional techniques or as >= 1 cm
with spiral CT scan

- Patients with non-measurable disease are not eligible; all other lesions,
including small lesions (longest diameter < 20 mm with conventional techniques or
< 10 mm with spiral CT scan) and truly nonmeasurable lesions; lesions that are
considered non-measurable include the following:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Inflammatory breast disease

- Lymphangitis cutis/pulmonis

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

9. Eastern Cooperative Oncology Group (ECOG) performance status 0-1

10. No patients that are known to be pregnant or nursing

11. Granulocytes ≥ 1,500/μl Platelet count ≥ 100,000/μl Bilirubin ≤ 1.5 times upper limit
of normal (ULN) Aspartate aminotransferase (AST) (serum glutamic oxalo-acetic
transaminase [SGOT]) ≤ 2.0 times ULN Serum creatinine ≤ 1.5 times ULN OR calculated
creatinine clearance >= 70 mL/min FEV-1 ≥ 1.2 L/sec or 50% predicted