Open label study of erlotinib (Tarceva®) as single agent first line treatment of patients with locally advanced or metastatic lung adenocarcinoma with activating Epidermal Growth Factor Receptor (EGFR) mutations MedDRA version: 16.0 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 16.0 Level: PT Classification code 10029521 Term: Non-small cell lung
Conditions
Interventions
Trade Name: Tarceva
Pharmaceutical Form: Film-coated tablet
Trade Name: Tarceva
Pharmaceutical Form: Film-coated tablet
Sponsors
Roche (Magyarország) Kft.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically or cytologically documented diagnosis of inoperable, locally advanced, recurrent or metastatic (Stage IIIB or Stage IV) lung adenocarcinoma. NSCLC with an activating EGFR mutation (exon 19 microdeletions or exon 21 L858R point mutation) by using Cobas® 4800 EGFR mutation testing kit at a designated central laboratory. Eastern Cooperative Oncology Group Performance Status of 0-2. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Prior chemotherapy or other systemic anti-cancer treatment. Neoadjuvant/adjuvant chemotherapy is allowed, if completed more than 6 months prior to study treatment. Prior radiochemotherapy is allowed, if completed more than 6 months before start of study treatment. Palliative radiotherapy must be completed at least 4 weeks before start of study treatment. Prior therapy with systemic anti-tumor therapy with HER1/EGFR inhibitors. Radical radiotherapy with curative intent within 28 days prior to enrolment. Patients are excluded if they have brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation; patients previously diagnosed and treated central nervous system (CNS) metastases or spinal cord compression without evidence of stable disease (clinically stable imaging) for at least 2 months will also cause patients to be excluded. Any inflammatory changes of the surface of the eye
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the Progression Free Survival of Tarceva in patients with locally advanced or metastatic lung adenocarcinoma with activating EGFR mutations (identified by the Cobas® 4800 EGFR Mutation Test) in the routine clinical practice;Secondary Objective: To evaluate the Objective Response Rate and 1-Year Survival Rate To evaluate the safety profile of Tarceva in this patient population. ;Primary end point(s): Progression Free Survival;Timepoint(s) of evaluation of this end point: Timeframe: 30 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Tumor response (RECIST version 1.1.) 1-Year Survival Rate Safety: Incidence, type and severity of adverse events ;Timepoint(s) of evaluation of this end point: Tumor response (RECIST version 1.1.) 1-Year Survival Rate Safety: Incidence, type and severity of adverse events | — |
Countries
Hungary, Latvia, Slovakia, Turkey
Outcome results
None listed