Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: June 21, 2011
Last updated: November 3, 2014
Last verified: November 2014

June 21, 2011
November 3, 2014
March 2011
April 2015   (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 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
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 Identifier (NCT Number) in Medline.
Active, not recruiting
April 2015
April 2015   (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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

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