NCT01609543

A Study of Tarceva (Erlotinib) in First Line in Patients With Locally Advanced or Metastatic Lung Adenocarcinoma With EGFR Mutations

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This open-label, non-randomized, one-arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as single-agent first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer who show epidermal growth factor receptor (EGFR) activating mutations. Patients will receive Tarceva 150 mg orally daily until disease progression or unacceptable toxicity occurs.

Conditions

• Non-Squamous Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	erlotinib [Tarceva]	150 mg orally daily, until disease progression, unacceptable toxicity or withdrawal due to any reason

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2012-06-01
• Last updated: 2016-02-01
• Results posted: 2016-02-01

Locations

23 sites across 3 countries: Hungary, Latvia, Turkey (Türkiye)