Prospective Evaluation of Small Molecule EGFR-1 Tyrosine Kinase Inhibition as a First-Line Treatment in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Harbouring a Mutant EGFR Gene

Study Objective

Primary Objective

To investigate the efficacy and feasibility of using a small molecule EGFR inhibition in the first-line treatment of non-small cell lung cancer carrying (a) EGFR kinase domain mutation(s) not amenable to curative treatment.

Secondary Objective

• Determine response rate (OR and stable disease) and duration under erlonitib treatment;
• Determine the effect on Quality of Life (QOL) of first-line anti-EGFR-1 treatment
• Determine the value of positron emission tomography (Pet)-scan an early predictor of response and clinical benefit
• Overall survival from the time of study entry to the date of death or date of last follow-up.
• Determine biological correlates for response / resistance in tumour tissues.

Participation conditions

Inclusion Criteria

• Histological or cytological documented diagnosis of inoperable, locally advanced, recurrent or metastatic (Stage IIIB or Stage IV) adenocarcinoma of the lung in a patient with a smoking history of <15 years and quit smoking > 1 year before diagnosis.
• Patients must have evidence of disease but measurable disease is not mandatory.
• Patients not eligible for standard curative –intent treatment with surgery or chemotherapy.
• Life expectancy ≥ 3 months
• Prior therapy for NSCLC allowed for primary disease: surgery and radiotherapy and adjuvant or proto-adjuvant chemotherapy completed > 6 months before inclusion
• 18 years of age or older…

Exclusion criteria

• Patients with previously untreated disease from whom urgent chemotherapy or radiotherapy is deemed necessary (e.g. rapidly progressive disease).
• Absence of tumour biopsy material available for mutation analysis
• Current symptomatic central nervous disorder, brain or leptomeningeal metastasis. Previously diagnosed and treated CNS metastasis with evidence of stable disease for at least 2 months is permitted.
• Pre-existing symptomatic lung disease, not related with the current malignancy
• Patients with a history of other malignancies, except patients with basal cell carcinoma of the skin or in situ carcinoma of the cervix.
• Prior chemotherapy for metastatic disease…

CHL