Cisplatin/Irinotecan With Concurrent Radiation for Inoperable NSCLC

Patients with histological documented non-small cell lung cancer, that are considered to be
inoperable, meet all the eligibility criteria, and sign informed consent will be treated with
one cycle of irinotecan and cisplatin, followed by three additional cycles of chemotherapy
with 60 - 70 Gy of concurrent radiation therapy.

Inclusion Criteria:

- Histological or cytological documented NSCLC, including squamous cell carcinoma,
adenocarcinoma, large cell carcinoma including large cell neuroendocrine carcinoma
adenosquamous and sarcomatoid carcinomas.

- Patients with Pancoast tumors adjacent to a vertebral body are eligible as long as all
gross disease can be encompassed in the radiation boost field. Pancoast tumor patients
will be so-noted in the registry.

- Patients must be ≥ 18 years of age.

- Patients with Zubrod (ECOG) performance status ≤ 2.

- Adequate hematologic function defined as: ANC ≥ 1000/mm3, platelets ≥ 75,000/mm3, and
hemoglobin ≥ 8 g/dL (prior to transfusions); adequate hepatic function defined as:
total bilirubin ≤ 3.0 mg/dl, and adequate renal function defined as a serum creatinine
level ≤ 2.0 mg/dl.

- Patients with weight loss ≤ 20% over the past 3 months.

- Patients with a pleural effusion that is proven cytologically negative or is too small
to tap.

- Women of childbearing potential must agree to practice effective contraception
throughout the study and for four weeks after completion of treatment.

- Pretreatment evaluations required for eligibility include:

- A medical history, physical examination, and assessment of Zubrod performance
status within 4 weeks prior to study entry.

- CBC with differential and platelet count, and laboratory profile must be
completed within 4 weeks prior to study entry.

- CT scan of the chest or whole body PET (preferred), and a CT scan or MRI
(preferred) of the brain within 4 weeks prior to study entry.

- For women of childbearing potential, a serum or urine pregnancy test (minimum
sensitivity 25 IU/L or equivalent units of HCG) must be performed within a week
prior to the start of protocol treatment.

- Medical Oncology and Radiation Oncology consultation and approval.

- Patients must sign a study-specific consent form prior to study entry.

Exclusion Criteria:

- Small cell carcinomas or carcinoid histology.

- History of any malignancy in the past 2 years except for adequately treated basal cell
or squamous cell skin cancer, in situ cervical cancer, or other in situ cancers.

- Prior systemic chemotherapy or radiotherapy that would interfere with delivery of
treatment as outlined above as judged by the clinician.

- Cytologically malignant effusions.

- Radiographic evidence of metastatic disease.

- Active pulmonary infection not responsive to antimicrobial therapy.

- History of significant or symptomatic interstitial pneumonitis.

- Significant symptomatic cardiac disease, for example, unstable angina, uncompensated
congestive heart failure, or uncontrolled cardiac ventricular arrhythmias.

- Patients with > grade 2 neuropathy.

- Women who are pregnant or breast feeding, as treatment involves unforeseeable risks to
the participant, embryo, fetus, or nursing infant; women with a positive pregnancy
test on enrollment or prior to study drug administration.

- Women of childbearing potential who are unwilling to practice effective contraception
throughout the study and for four weeks after completion of treatment.

- Patients who currently are participating in other clinical trials and/or who have
participated in other clinical trials in the previous 30 days.