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

Roche

Status and phase: Completed; Phase 2

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Treatments: Drug: erlotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01378962

ML25514

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Single Arm

Experimental group

Treatment:

Drug: erlotinib