A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Present EGFR Mutations
|ClinicalTrials.gov Identifier: NCT01287754|
Recruitment Status : Completed
First Posted : February 1, 2011
Results First Posted : June 2, 2015
Last Update Posted : June 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Drug: erlotinib [Tarceva]||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A 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|
|Study Start Date :||October 2011|
|Primary Completion Date :||November 2013|
|Study Completion Date :||November 2013|
|Experimental: Single Arm||
Drug: erlotinib [Tarceva]
150 mg daily orally
- Progression-Free Survival (PFS) Among Erlotinib-Treated Participants With the EGFR Mutation [ Time Frame: Per standard of care (every 3 months) until discontinuation for up to approximately 2 years ]PFS was defined as the time from the first dose of erlotinib to the first documentation of disease progression or death, whichever occurred first. Tumor progression was determined using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), which defines progression as a 20 percent (%) or greater increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeters (mm), or the appearance of one or more new lesions. PFS was calculated in months as [first event date minus first dose date plus 1] divided by 30.44.
- Number of Erlotinib-Treated Participants With the EGFR Mutation With an Objective Response Per RECIST v1.1 [ Time Frame: Per standard of care (every 3 months) until discontinuation for up to approximately 2 years ]Objective tumor response was assessed by the investigator using RECIST v1.1 and recorded as complete response (CR), partial response (PR), or unmeasurable. RECIST v1.1 defines CR as disappearance of all target lesions, with short-axis reduction to less than (<) 10 mm for any pathological lymph nodes, and PR as a 30% or greater reduction from baseline in the sum of diameters of target lesions.
- Overall Survival (OS) Among Erlotinib-Treated and Untreated Participants [ Time Frame: Per standard of care (every 3 months) until discontinuation for up to approximately 2 years ]OS was defined as the time from recorded diagnosis to death from any cause or last patient last visit. OS was calculated in months as [death date or last-known alive date minus diagnosis date plus 1] divided by 30.44.
- Percentage of Participants Alive at 6 and 12 Months [ Time Frame: At 6 and 12 months ]Death from any cause was documented at 6 and 12 months from recorded diagnosis. The percentage of participants alive at each timepoint was calculated as [number of participants alive divided by number enrolled] multiplied by 100.
- Percentage of Participants With EGFR Mutation at Screening [ Time Frame: Screening ]Participants were tested at Screening for the presence of activating mutations in the tyrosine kinase domain of EGFR. The percentage of participants with mutation was calculated as [number of mutation-positive participants divided by number tested] multiplied by 100.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01287754
|Helsinki, Finland, 00290|
|Kuopio, Finland, 70211|
|Oulu, Finland, 90029|
|Pori, Finland, 28500|
|Turku, Finland, 20521|
|Study Director:||Clinical Trials||Hoffmann-La Roche|