Overview

This trial is active, not recruiting.

Condition non-squamous non-small cell lung cancer
Treatment erlotinib [tarceva]
Phase phase 2
Sponsor Hoffmann-La Roche
Start date March 2011
End date December 2015
Trial size 50 participants
Trial identifier NCT01378962, ML25514

Summary

This single-arm, open-label study will evaluate the efficacy and safety of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer. Patients will receive daily oral doses of 150 mg Tarceva. The anticipated time on study treatment is 12 months.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
erlotinib [tarceva]
150 mg orally once a day for 12 months

Primary Outcomes

Measure
Progression-free survival
time frame: 12 months

Secondary Outcomes

Measure
Objective response assessed by the investigator
time frame: 12 months
Safety: Incidence of adverse events
time frame: 12 months
Overall survival
time frame: 12 months
Epidermal growth factor receptor mutation status
time frame: 12 months
Tumor response rate
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult patients, >/=18 years of age - Locally advanced or metastatic non-small cell lung cancer - Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Life expectancy over >/=12 weeks - Adequate hematological, liver, or kidney function Exclusion Criteria: - Previous therapy against epidermal growth factor receptor for metastatic disease - Treatment with investigational drug during the 3 weeks before enrollment - History of neoplasm - Patients with symptomatic cerebral metastases - Unstable systemic disease

Additional Information

Official title Phase II, Open-label Study of Erlotinib (Tarceva®) Treatment in Patients With Locally Advanced or Metastatic Non-small-cell Lung Cancer Who Present Activating Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor (EGFR) - (TRIGGER)
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.