Phase II Study of Taxotere® (Docetaxel) + ZD1839 (IRESSA®) in Previously Untreated Elderly Patients (≥70 Years Old) With Stage III-b (With Malignant Pleural Effusion [MPE+]) or Stage IV Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria:

- Patients must be greater than or equal to 70 years of age.

- Patients must have histologically confirmed non-small cell lung cancer (NSCLC) that
is Stage IIIb (with pleural effusions) or Stage IV.

- Patients must be previously untreated for metastatic disease but may have received
previous adjuvant chemotherapy more than six months prior to registration. Patients
may also have received radiation therapy for advanced disease; however there should
be measurable disease outside the radiation ports.

- Disease must be at least unidimensionally measurable. Lesions, which are located
within a previously irradiated field, are not considered measurable unless there is a
documented growth in its size.

- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of
0 or 1.

- Laboratory values must be as follows: White blood cell count greater than or equal to
3,000/mm^3; Absolute neutrophil count greater than or equal to 1,500/mm^3; Platelets
greater than or equal to 100,000/mm^3; Total bilirubin less than or equal to 1.0 x
institutional upper normal limit; Serum creatinine less than or equal to 2 x
institutional upper normal limit; aspartic transaminase (AST) or ALANINE TRANSAMINASE
(ALT) less than or equal to 1.5 x institutional upper normal limit; Alkaline
Phosphatase less than or equal to 1.5 x institutional upper normal limit; Serum
calcium less than or equal to 1.5 x institutional upper normal limit (corrected for
serum albumin).

- Patients with combined alkaline phosphatase, AST and/or ALT elevations will not be
allowed to enroll on protocol.

- Patients must have recovered from all acute toxicities from previous therapy,
excluding alopecia.

- In keeping with the policies of the institution, patients must sign an informed
consent form indicating that they are aware of the investigational nature of this
study

- Patients with stable brain metastases after completion of radiation will be allowed
to enroll in this trial.

- Patients treated with adjuvant therapy more than six months ago will be allowed to
enroll in this trial.

- Cognitively impaired patients will be allowed to enroll on the trial if the legal
guardian signs the consent form after a full informed consent process is completed.
Whenever feasible the cognitively impaired person will also give assent to
participation in the trial.

Exclusion Criteria:

- Patients previously treated with chemotherapy or ZD1839.

- Patients with known or clinical evidence of active central nervous system (CNS)
metastasis. Patients with stable, previously treated brain metastases will be
allowed.

- Male Patients with female sexual partners in the reproductive age group who refuse to
use effective methods of contraception will be excluded from the trial.

- Patients with concurrent serious infections (i.e., receiving an intravenous
antibiotic) are not eligible.

- Patients with an unstable or serious concurrent medical condition are excluded.
Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent
(within 3 months) myocardial infarction, uncontrolled major seizure disorder, grade 3
neuropathies, spinal cord compression, superior vena cava syndrome, or any
psychiatric disorder that prohibits obtaining informed consent.

- Patients receiving other non-approved or investigational therapy concurrently or
within 30 days of Day 1 of trial treatment.

- Patients with a history of other cancers except basal cell skin cancers, carcinoma of
the cervix in situ, or curatively-treated cancers with > 2 years non-recurrence prior
to entry in the trial. Patients with a history of other cancers must have
histological confirmation that current disease is compatible with diagnosis of NSCLC.

- Peripheral neuropathy >2. (Peripheral neuropathy must be < grade 1)

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to Docetaxel, ZD 1839, Polysorbate 80, or other agents used in the study.

- Patients with combined alkaline phosphatase, AST and/or ALT elevations will be
excluded from this protocol.

- Patients previously treated with radiation therapy.