Molecular And Genetic Changes In Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) Following Neoadjuvant Chemotherapy With Vinorelbine And Gemcitabine - Phase II Study

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed non-small cell carcinoma of the lung

- May be confirmed at the initial bronchoscopy and mediastinoscopy

- Stage IB (T2, N0, M0)

- Stage IIA (T1, N1, M0)

- Stage IIB (T2-3, N0-1, M0)

- Stage IIIA (T1-3, N1-2, M0)

- stage IIIB (2 lesions in 1 lobe [T4])

- No N3 lymph nodes (contralateral mediastinal/hilar and supraclavicular/scaline) OR T4
primary tumor (malignant pleural effusion or mediastinal invasion) by clinical
staging criteria (seen on CT or PET scan and proven by mediastinoscopy)

- No metastatic disease (except N1 or N2 disease) or malignant pleural effusion*
detected on preoperative evaluation

- No exudative effusions (even if cytologically negative)

- Pleural fluid is considered exudative if the following apply:

- Ratio of pleural fluid protein to serum protein is greater than 0.5

- Ratio of pleural fluid lactic dehydrogenase (LDH) to serum LDH is at
least 0.6

- Pleural fluid LDH is greater than 200 IU/L

- No multiple areas of fluorodeoxyglucose (FDG) uptake** outside the area of the
primary tumor in the lung NOTE: *Effusions visible only on CT scan and not large
enough for safe thoracentesis are allowed

NOTE: **If only 1 area shows an increase in FDG uptake, the area of concern requires
further evaluation (e.g., biopsy) to exclude metastatic disease

- Bidimensionally measurable or evaluable disease* NOTE: *Lesions apparent on chest CT
scan (e.g., ill-defined masses associated with post obstructive changes and
mediastinal or hilar adenopathy measurable in 1 dimension) are considered evaluable

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- WBC at least 3,000/mm^3

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

- Hemoglobin at least 9 g/dL

Hepatic

- Bilirubin no greater than 1.5 mg/dL

- AST or ALT no greater than 1.5 times upper limit of normal

Renal

- Creatinine no greater than 1.5 mg/dL

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Deemed medically fit for surgical resection

- No other active malignancy within the past 2 years except nonmelanoma skin cancer or
carcinoma in situ of the cervix

- No psychological, sociological, or geographical condition that would preclude study
compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Concurrent participation in the RPCI vaccine study (postoperative vaccination with
autologous tumor-associated antigen-pulsed dendritic cells) is allowed

Chemotherapy

- No prior chemotherapy for lung cancer

- No concurrent participation in another study involving other chemotherapy agents

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy for lung cancer

- No concurrent participation in another study involving radiotherapy

Surgery

- No prior surgery for lung cancer

- More than 3 months since other prior major surgery (e.g., coronary artery bypass
graft)

Other

- No other prior therapy for lung cancer

- No other concurrent antineoplastic agents

- Concurrent participation in observational studies requiring bloodwork, radiographs,
pulmonary function tests, or quality of life studies is allowed