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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01378962
First received: June 21, 2011
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

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


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: erlotinib [Tarceva]
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response assessed by the investigator [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Epidermal growth factor receptor mutation status [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Tumor response rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: March 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: erlotinib [Tarceva]
150 mg orally once a day for 12 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01378962

Locations
Italy
Napoli, Campania, Italy, 80131
Bologna, Emilia-Romagna, Italy, 40133
Modena, Emilia-Romagna, Italy, 41100
Roma, Lazio, Italy, 00168
Milano, Lombardia, Italy, 20141
Rozzano, Lombardia, Italy, 20089
Catania, Sicilia, Italy, 95122
Palermo, Sicilia, Italy, 90127
Pisa, Toscana, Italy, 56124
Perugia, Umbria, Italy, 06156
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01378962     History of Changes
Other Study ID Numbers: ML25514
Study First Received: June 21, 2011
Last Updated: October 6, 2014
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Erlotinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on October 22, 2014