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 1, 2015
Last verified: October 2015
  Purpose
This single-arm, open-label study will evaluate the efficacy and safety of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer. Patients will receive daily oral doses of 150 mg Tarceva. The anticipated time on study treatment is 12 months.

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

Study Type: Interventional
Study Design: 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:
  • Percentage of Participants With Disease Progression or Death at 12 Months After Baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.

  • Progression-Free Survival (PFS) [ Time Frame: Up to 1 year after enrollment of the last participant (maximum up to 27 months) ] [ Designated as safety issue: No ]
    PFS was defined as the time from baseline to the date of first occurrence of disease progression or death. According to RECIST v1.1, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. PFS was assessed using Kaplan-Meier method.

  • Probability of Being Progression Free 12 Months After Baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    According to RECIST v1.1, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.


Secondary Outcome Measures:
  • Percentage of Participants Who Died [ Time Frame: Every 8 weeks during treatment, after discontinuation participants were followed for up to 1 year after enrollment of the last participant (maximum up to 27 months) ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: Every 8 weeks during treatment, after discontinuation participants were followed for up to 1 year after enrollment of the last participant (maximum up to 27 months) ] [ Designated as safety issue: No ]
    OS was defined as the time from randomization to the date of death due to any cause. OS was assessed using Kaplan-Meier method.

  • Percentage of Participants With a Response by Best Overall Response [ Time Frame: Baseline up to disease progression or end of study (up to 12 Months) ] [ Designated as safety issue: No ]
    Tumor response was assessed by the investigator using computed tomography (CT) scans according to RECIST v1.1. Complete response (CR) was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than 10 mm), with no new lesions. Partial response (PR) was defined as greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. PD is defined in Outcome Measure 1. Stable disease (SD) was defined as not qualifying for CR, PR, or PD. The best overall response achieved from start of treatment until disease progression or end of study is presented.

  • Percentage of Participants With Objective Response [ Time Frame: Baseline up to disease progression or end of study (up to 12 Months) ] [ Designated as safety issue: No ]
    Objective response was defined as the percentage of participants with CR or PR as best overall response by RECIST v1.1. To be assigned the status of PR or CR, changes in tumor measurements were to be confirmed by repeated assessments no less than 4 weeks after the criteria for response were first met. CR was defined as complete disappearance of all target lesions and non-target disease, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than 10 mm), with no new lesions. PR was defined as >=30% decrease under baseline of sum of diameters of all target lesions. The short axis was used in sum for target nodes, while longest diameter was used in sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. Participants with no tumor assessment after start of study treatment were considered as non-responders. The percentage of participants with response is presented.

  • Percentage of Participants Achieving CR, PR, or SD as Best Overall Response [ Time Frame: Baseline up to disease progression or end of study (up to 12 Months) ] [ Designated as safety issue: No ]
    The Disease Control Rate was defined as the percentage of participants who had CR or PR or SD as Best Overall Response achieved within the time between the first drug administration and documented disease progression or end of study. According to RECIST v1.1, CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than 10 mm), with no new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. SD was defined as not qualifying for CR, PR, or PD.

  • Percentage of Participants With Primary and Secondary Resistance [ Time Frame: Baseline up to disease progression (up to 12 Months) ] [ Designated as safety issue: No ]
    Primary resistance was defined as participants did not reach SD or PR or CR before going to PD. While secondary resistance was defined as participants experienced PD after having reached SD or PR or CR at least once. Please refer to above outcome measures 1 and 6 for definition of CR, PR, SD, and PD.

  • Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Mutation by Mutation Type [ Time Frame: Baseline, At progression of disease ] [ Designated as safety issue: No ]
    EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR mutation was determined in liquid biopsies by reverse transcriptase-polymerase chain reaction (RT-PCR /Cobas).


Enrollment: 50
Study Start Date: March 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (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
Results First Received: September 30, 2015
Last Updated: October 1, 2015
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 February 10, 2016