Clinical trial NCT01951755: Phase IV Study of Tarceva in Patients With Advanced Stage IIIB/ IV Non-small Cell Lung Cancer (NSCLC)
Official title: An Observational Study for Safety and Efficacy of Erlotinib Beyond 1st Line in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Keywords: Inoperable NSCLC
TKIs
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2013-09-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced (inoperable stage IIIB or stage IV) NSCLC who had failed in platinum based chemotherapy

Brief summary: An open-label, non randomized clinical trial of Tarceva as single agent in progressed non-small cell lung cancer patients.

Detailed description: An observational non randomized clinical trial of Tarceva as single agent in progressed non-small cell lung cancer patients after chemotherapy.

Eligibility criteria: Inclusion Criteria:

* Histological or cytological documented diagnosis diagnosis of inoperable, locally advanced, recurrent or metastatic (Stage IIIB or IV) NSCLC.
* Patients must have evidence of disease but measurable disease is not mandatory.
* 18 years of age or older.
* ECOG Performance Status of 0-2.
* Life expectancy at least 12 weeks.
* Patients with advanced stage IIIB/ IV NSCLC who have received at least one course of standard systemic chemotherapy or radiation therapy or who are in the investigator's opinion not medically suitable for chemotherapy or radiotherapy.
* No more than 2 prior chemotherapy regimens are permissible. Patients must have recovered from any toxic effects and at least 3-4 weeks must have elapsed from the last dose and prior to registration (14 days for vinorelbine or other vinca alkaloids or gemcitabine). Patients who, in the opinion of the investigator, have fully recovered from surgery in less than 4 weeks may also be considered for the study. Patients must have recovered (CTC ≤ 1) from acute toxicities of any previous therapy.
* Granulocyte count ≥ 1.5 x 109/L and platelet count \> 100 x 109/L.
* Serum bilirubin must be ≤ 1.5 upper limit of normal (ULN).
* AST and/or ALT ≤ 2 x ULN (or ≤ 5 x ULN if clearly attributable to liver metastasis.
* Serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 60 ml/min.
* Able to comply with study and follow-up procedures.
* For all females of childbearing potential a negative pregnancy test must be obtained within 72 hours before starting therapy.
* Patients with reproductive potential must use effective contraception.
* Written (signed) Informed Consent to participate in the study.

Exclusion Criteria:

* Any unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease).
* Prior therapy with systemic anti-tumour therapy with HER1/EGFR inhibitors (as small molecule or monoclonal antibody therapy).
* Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
* Patients are excluded if they have brain metastasis 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 permitted.
* Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjogren 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 ophthalmologist.
* Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease.
* Nursing mothers.

Primary outcomes:
measure: Progression Free Survival
timeFrame: 24 months
Secondary outcomes:
measure: Safety
timeFrame: Baseline, 4-6 months, 12 months, 24 months
Other outcomes:
measure: Response Rate
timeFrame: 4-6 months, 12 months, 24 months
Locations:
city: Athens
country: Greece
facility: Oncology Unit Sotiria Hospital of Chest Diseases
Study officials:
affiliation: Oncology Unit University of Athens, Sotiria Hosp, 152 Mesogion Av
name: KOSTAS N SYRIGOS, MD, PhD
role: STUDY_CHAIR
References: