A Study of first-line Tarceva treatment in Patients with Advanced lung Adenocarcinoma with EGFR mutations

• Conditions: 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: 16.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-002168-26-LV
• Lead Sponsor: Roche (Magyarország) Kft.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-15
• Last Update Posted: 16 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 68

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified