Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Inoperable Stage III Non-Small Cell Lung Cancer

Inclusion Criteria:

• Histologically confirmed non-small cell lung cancer

  • Squamous cell carcinoma
  • Adenocarcinoma (including bronchoalveolar)
  • Large cell carcinoma (including giant and clear cell carcinomas)
• Stage IIIA (T1 or T2, N2) or IIIB disease not amenable to resection or surgery
• T3, N2 or T4, N0-N2 disease also allowed if based on the closeness to the carina, invasion of the mediastinum, or invasion of the chest wall
• T3, N0-N1 disease allowed provided the disease is not amenable for surgical resection
• No M1 disease

• No disease invasion of a vertebral body

  • Tumors adjacent to a vertebral body allowed provided all gross disease can be encompassed in the radiotherapy boost field and there is no bone invasion
• Contralateral mediastinal disease (N3) allowed if all gross disease can be encompassed in the radiotherapy boost field

• Pleural effusion that is transudative, cytologically negative, and non-bloody allowed if the tumor can be encompassed in a reasonable field of radiotherapy

  • No exudative, bloody, or cytologically malignant effusions
  • Effusions present on CT scans but not on chest x-ray (CXR) and too small for thoracentesis are allowed

• Measurable or evaluable disease

  • Pleural effusions are not considered measurable or evaluable
  • Measurable disease is defined as any mass in 2 perpendicular diameters by CXR, CT scan, or MRI

  • Evaluable disease includes lesions apparent on CXR or CT scan that are:

    • Ill-defined masses associated with post-obstructive changes
    • Mediastinal or hilar adenopathy measurable in only one dimension
• Performance status - ECOG 0-1
• Performance status - Karnofsky 70-100%
• More than 6 months
• WBC at least 3,000/mm^3
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Bilirubin normal
• AST and ALT no greater than 1.5 times upper limit of normal (ULN) and alkaline phosphatase normal
• AST and ALT normal and alkaline phosphatase no greater than 2.5 times ULN
• Creatinine normal
• Creatinine clearance at least 50 mL/min
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• No history of cornea abnormalities (e.g., dry-eye syndrome, Sjögren's syndrome)
• No congenital abnormality (e.g., Fuch's dystrophy)
• No abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal-Rose)
• No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test)
• No gastrointestinal tract disease resulting in the inability to take oral medications
• No required IV alimentation
• No peptic ulcer disease
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No history of allergy to compounds of similar chemical or biologic composition to erlotinib or other study agents
• No significant traumatic injury within the past 21 days
• No other uncontrolled concurrent illness
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance
• No other active malignancy within the past 6 months except non-melanoma skin cancer
• No concurrent colony-stimulating factors (filgrastim [G-CSF] or sargramostim [GM-CSF]) with radiotherapy
• No prior chemotherapy for lung cancer
• See Disease Characteristics
• No prior chest radiotherapy
• See Disease Characteristics
• At least 7 days since prior mediastinoscopy
• More than 3 weeks since prior formal exploratory thoracotomy
• More than 3 weeks since prior major surgery
• No prior surgical procedures affecting absorption
• No prior epidermal growth factor receptor-targeting therapies
• No other concurrent investigational or commercial agents or therapies directed at malignancy
• No concurrent combination antiretroviral therapy for HIV-positive patients