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A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (TRIGGER)

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Interventions: erlotinib

Countries: Italy

This single-arm, open-label study evaluated the efficacy and safety of Tarceva (erlotinib) in participants with locally advanced or metastatic non-small cell lung cancer. Participants received daily oral doses of 150 mg Tarceva. The anticipated time on study treatment was 12 months.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (10)

Naples, Campania, Italy
Bologna, Emilia-Romagna, Italy
Modena, Emilia-Romagna, Italy
Rome, Lazio, Italy
Milan, Lombardy, Italy
Rozzano, Lombardy, Italy
Catania, Sicily, Italy
Palermo, Sicily, Italy
Pisa, Tuscany, Italy
Perugia, Umbria, Italy