A Phase III Randomized, Open-Label Comparative Study of Induction Chemotherapy Followed by Thoracic Radiation Therapy With Supplemental Oxygen, With or Without Concurrent RSR13 (Efaproxiral), in Patients With Locally Advanced Unresectable (Stage IIIA/IIIB) Non-Small Cell Lung Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed locally advanced, unresectable non-small
cell lung cancer of 1 of the following subtypes:

- Adenocarcinoma

- Squamous cell carcinoma

- Large cell carcinoma

- Poorly differentiated carcinoma

- Stage IIIA or IIIB

- T1 or T2, N2

- T3, N1 or N2

- T4, any N

- Any T, N3

- Histological or cytological confirmation of at least 1 positive lymph node required
if the largest mediastinal node that is the basis of stage III disease is less than
2.0 cm in diameter

- Clinically or radiologically measurable disease of at least 2.0 cm

- Partially resected stage IIIB disease allowed provided a measurable lesion remains

- No pleural effusion that is bloody, cytologically positive, or re-accumulated after
thoracentesis

- No metastatic disease by CT scan or MRI

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Karnofsky 70-100%

Life expectancy

- Not specified

Hematopoietic

- Hemoglobin at least 10 g/dL

- WBC at least 3,000/mm^3

- Absolute granulocyte count at least 2,000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST and ALT no greater than 2.5 times ULN

Renal

- Creatinine no greater than 1.5 mg/dL

Cardiovascular

- No clinically active congestive heart failure

- No unstable angina

- No severe arrhythmia by ECG

Pulmonary

- FVC and FEV_1 at least 50% of normal

- Resting oxygen saturation by pulse oximetry (SpO_2) at least 90% on room air

- Exercise SpO_2 at least 90% on room air

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile female patients must use effective contraception during and for 30 days after
study therapy

- Male patients must use effective contraception during and for 90 days after study
therapy

- No loss of more than 10% of body weight within the past 3 months

- No other malignancy within the past 5 years except nonmelanoma skin cancer or
carcinoma in situ of the cervix

- No significantly altered mental status or dementia that would preclude giving
informed consent

- No active infection

- No other serious underlying medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- More than 28 days since prior biologic therapy

- No concurrent colony-stimulating factors (randomized phase only)

- No biologic therapy during and for 1 month after study therapy

- No immune response modifiers during and for 1 month after study therapy

Chemotherapy

- No prior systemic chemotherapy

Endocrine therapy

- No hormonal therapy during and for 1 month after study therapy

Radiotherapy

- No prior thoracic radiotherapy

Surgery

- See Disease Characteristics

- No prior total surgical resection

Other

- More than 28 days since prior investigational drugs or devices

- No prior efaproxiral

- No other cytotoxic therapy during and for 1 month after study therapy