A Phase II Open-Label Study Designed to Evaluate the Efficacy and Safety, of Erlotinib in Combination With Docetaxel in Selected Non Small Cell Lung Cancer Patients Eligible for First Line Treatment
1. Male or female subjects, above 18 years of age at the time of enrollment.
2. Subject aged 18-65 must have ECOG performance status of 2 and subjects above 65 must
have ECOG PS 0-2.
3. Histological or cytological documented diagnosis of inoperable, locally advanced
(with pleural effusion), recurrent or metastatic (Stage IIIB or Stage IV) NSCLC.
4. Patients must have evidence of measurable disease with at least one measurable or
5. Eligible for first line monotherapy treatment (or no prior chemotherapy or radiation
treatments for this indication). Palliative localized radiation is allowed.
6. Life expectancy of at least 12 weeks.
7. Adequate bone marrow function as shown by: WBC >= 3.0 x 109/L, ANC >=1.5 x 109/L,
Platelets >=100 x 109/L, Hgb >=10g/dL.
8. Subjects must have normal organ function as defined below:
- AST (SGOT) / ALT (SGPT) ≤ 2 x upper limit of normal (ULN),
- Serum creatinine ≤ 1.5 x ULN or creatinine clearance > 60 ml/min
- Coagulation markers - PT and PTT (or INR) within normal limits unless subjects
are already anti-coagulated for other reasons (i.e., atrial fibrillation, etc.).
9. Signed written informed consent to participate in the study.
10. Ability to comply with the requirements of the study.
1. Participation in an investigational trial within 30 days of the screening visit.
2. History of allergic reactions attributed to compounds of similar chemical or biologic
composition to erlotinib or docetaxel.
3. Have a previous (unless disease free for more than five years) or concurrent
malignancy besides NSCLC (except for adequately treated carcinoma in situ of the
cervix or basal or squamous cell skin cancer).
4. Subjects with known brain metastases or spinal cord compression that is newly
diagnosed and/or has not yet been definitively treated with surgery and/or radiation;
previously diagnosed and treated CNS metastases or spinal cord compression with
evidence of stable disease (clinically stable imaging) for at least 2 months is
5. Subjects with preexisting neuropathy ≥ grade 2.
6. Current serious infections.
7. Current known acute or chronic infection with HBV or HCV.
8. Known human immunodeficiency virus (HIV) infection.
9. Any significant ophthalmologic abnormality, especially severe dry eye syndrome,
keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other
disorder likely to increase the risk of corneal epithelial lesions. The use of
contact lenses is not recommended during the study. The decision to continue to wear
contact lenses should be discussed with the patient's treating Oncologist and the
10. Subjects with other concurrent severe and/or uncontrolled medical condition which
could compromise participation in the study (i.e. active infection, uncontrolled
diabetes, uncontrolled hypertension - grade 4, congestive cardiac failure, unstable
angina, ventricular arrhythmias, active ischemic heart disease, myocardial infarction
within six months, chronic liver or renal or metabolic disease, active upper GI tract
11. Any chronic or acute condition susceptible of interfering with the evaluation of drug
12. Any form of substance abuse (including drug or alcohol abuse), psychiatric disorder
or any chronic condition susceptible, in the opinion of the investigator, of
interfering with the conduct of the study.
13. Organ allograft or previous history of stem cell transplantation.
14. Subjects who received anti-neoplastic therapy, radiation therapy or had surgery
within 28 days prior to the start of study agent administration or who have not
recovered from the toxic effects of such therapy. Palliative localized radiation is
15. Subjects who cannot take oral medication, who require intravenous alimentation, have
had prior surgical procedures affecting absorption, or have active peptic ulcer
16. Fertile subjects who are not willing to use an acceptable method of contraception
during the treatment period and for 28 days following completion of treatment.
17. For women of child-bearing potential: A positive pregnancy test at screening or
18. Subjects who are likely to be non-compliant or uncooperative during the study.