Clinical trial NCT01378962: A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (TRIGGER)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-06-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants With Disease Progression or Death at 12 Months After Baseline
timeFrame: 12 months
measure: Progression-Free Survival (PFS)
timeFrame: Up to 1 year after enrollment of the last participant (maximum up to 27 months)
measure: Probability of Being Progression Free 12 Months After Baseline
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of Participants Who Died
timeFrame: 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)
measure: Overall Survival (OS)
timeFrame: 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)
measure: Percentage of Participants With a Response by Best Overall Response
timeFrame: Baseline up to disease progression or end of study (up to 12 Months)
measure: Percentage of Participants With Objective Response
timeFrame: Baseline up to disease progression or end of study (up to 12 Months)
measure: Percentage of Participants Achieving CR, PR, or SD as Best Overall Response
timeFrame: Baseline up to disease progression or end of study (up to 12 Months)
measure: Percentage of Participants With Primary and Secondary Resistance
timeFrame: Baseline up to disease progression (up to 12 Months)
measure: Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Mutation by Mutation Type
timeFrame: Baseline, At progression of disease (up to 12 Months)
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A
state: Campania
city: Bologna
country: Italy
facility: Ospedale Bellaria; U.O. Oncologia Medica
state: Emilia-Romagna
city: Modena
country: Italy
facility: A.O. Universitaria Policlinico Di Modena; Ematologia
state: Emilia-Romagna
city: Roma
country: Italy
facility: Istituto Regina Elena; Oncologia Medica A
state: Lazio
city: Milano
country: Italy
facility: Istituto Europeo Di Oncologia
state: Lombardia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
state: Lombardia
city: Catania
country: Italy
facility: Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica
state: Sicilia
city: Palermo
country: Italy
facility: Policlinico P. Giaccone; Istituto Di Oncologia, Clinica Medica 1
state: Sicilia
city: Pisa
country: Italy
facility: A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii
state: Toscana
city: Perugia
country: Italy
facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
state: Umbria
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: