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: July 7, 2014
Last verified: July 2014

June 21, 2011
July 7, 2014
March 2011
June 2013   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01378962 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (TRIGGER)
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)

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
Drug: erlotinib [Tarceva]
150 mg orally once a day for 12 months
Experimental: Single Arm
Intervention: Drug: erlotinib [Tarceva]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01378962
ML25514
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP