A Phase II Study of TARCEVA (Erlotinib) in Combination With Chemoradiation in Patients With Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria:

1. Histologically or cytologically documented NSCLC, including squamous cell carcinoma,
adenocarcinoma (including bronchoalveolar cell), and large cell anaplastic carcinoma
(including giant and clear cell carcinomas) and poorly differentiated (not otherwise
specified (NOS)) non-small cell lung cancer; totally resected tumors are excluded.

2. Patients must be M0;

3. Patients with Tl or T2 disease with N2 or T3N1-2 disease (Stage IIIA) are eligible if
they are deemed inoperable. Patients with T4 with any N or any T with N2 or N3
disease are eligible if unresectable. Radiographic evidence of mediastinal lymph
nodes > 2.0 cm in the largest diameter is sufficient to stage N2 or N3 disease. If
the largest mediastinal node is < 2.0 cm in diameter and this is the basis for stage
III disease, then at least one of the nodes must be proven positive cytologically or
histologically;

4. Measurable disease is required

5. Patients with tumors adjacent to a vertebral body are eligible as long as all gross
disease can be encompassed in the radiation boost field. The boost volume must be
limited to < 50% of the ipsilateral lung volume.

6. Patients must be greater than or equal to 18 years of age;

7. Patients with Zubrod performance status 0-1

8. Adequate hematologic function defined as: Absolute neutrophil count (ANC) greater
than or equal 1,500/mm^3, platelets greater than or equal 100,000/mm^3, and
hemoglobin greater than or equal 9 g/dL (prior to transfusions); adequate hepatic
function defined as: total bilirubin less than or equal to 1.5 mg/dl, serum glutamic
oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase (SGPT) less
than or equal to 3 * upper limit of normal (ULN), adequate renal function defined as
a serum creatinine level less than or equal to 2.0 mg/dl, alkaline phosphatase less
than or equal to 2.5 * ULN, glucose less than or equal to 2 * ULN;

9. Forced expiratory volume in 1 second (FEV1) with greater than or equal to 1000 cc;

10. Patients with weight loss less than or equal to than
11. Patients with a pleural effusion that is a transudate, cytologically negative and
nonbloody are eligible if the radiation oncologists feel the tumor can still be
encompassed within a reasonable field of radiotherapy. If a pleural effusion can be
seen on the chest CT but not on CXR and is too small to tap, the patient is eligible.

12. If patients had exploratory thoracotomy, they must have recovered from the procedure.
Exploratory Thoracotomy and beginning of treatment should be within one month.

13. Women of childbearing potential (A woman of child-bearing potential is a sexually
mature woman who has not undergone a hysterectomy or who has not been naturally
postmenopausal for at least 24 consecutive months [i.e., who has had menses at any
time in the preceding 24 consecutive months]) and male participants must practice
effective contraception (oral, injectable, or implantable hormonal contraceptive;
tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or
vasectomized partner) throughout the study and for four weeks after completion of
treatment.

14. For women of childbearing potential, a urine or blood pregnancy test must be
performed within 48 hours prior to the start of protocol treatment;

15. Medical Oncology and Radiation Oncology consults and approval.

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

Exclusion Criteria:

1. Prior systemic chemotherapy and/or thoracic radiotherapy for any reason and/or
surgical resection of present cancer;

2. Exudative, bloody, or cytologically malignant effusion or effusion that are exudative
and/or bloody and are suggestive or malignant involvement.

3. Prior therapy with any other drug that targets the epidermal growth factor receptor
(EGFR) pathway,

4. Active pulmonary infection not responsive to conventional antibiotics;

5. History of interstitial lung disease;

6. History of severe Chronic obstructive pulmonary disease (COPD), requiring greater
than or equal to 3 hospitalizations over the past year;

7. Significant history of cardiac disease, i.e., uncontrolled hypertension, unstable
angina, uncompensated congestive heart failure, myocardial infarction within the past
year, or cardiac ventricular arrhythmias requiring medication; patients with left
ventricular ejection fraction (LVEF) below the institutional range of normal (50-70%)
on a baseline multiple gated acquisition (MUGA) scan or echocardiogram.

8. Patients with > grade 1 neuropathy;

9. Evidence of malignancy in the past 3 years except for adequately treated basal cell
or squamous cell skin cancer, in situ cervical cancer, or other in situ cancers;

10. 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;

11. Women of childbearing potential and male participants who are unwilling or unable to
use an acceptable method of contraception (oral, injectable, or implantable hormonal
contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with
spermicide; or vasectomized partner) throughout the study and for four weeks after
completion of treatment or those who are using a prohibited contraceptive method
(methods with unknown efficacy).

12. Patients who currently are participating in other clinical trials and/or who have
participated in other clinical trials in the previous 30 days. Clinical trials
involving administration of investigational agents or interfering with the safe
conduct of this trial. All clinical trials would exclude observational trials which
would not interfere with the endpoints of our study.