This single arm, open-label study will assess the efficacy and safety of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations. Patients will receive Tarceva at a dose of 150 mg daily orally until disease progression or unacceptable toxicity occurs.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
150 mg daily orally
Unnamed facility
Helsinki, Finland
Unnamed facility
Kuopio, Finland
Unnamed facility
Oulu, Finland
Unnamed facility
Pori, Finland
Unnamed facility
Turku, Finland
Progression-Free Survival (PFS) Among Erlotinib-Treated Participants With the EGFR Mutation
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.
Time frame: Per standard of care (every 3 months) until discontinuation for up to approximately 2 years
Number of Erlotinib-Treated Participants With the EGFR Mutation With an Objective Response Per RECIST v1.1
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.
Time frame: Per standard of care (every 3 months) until discontinuation for up to approximately 2 years
Overall Survival (OS) Among Erlotinib-Treated and Untreated Participants
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.
Time frame: Per standard of care (every 3 months) until discontinuation for up to approximately 2 years
Percentage of Participants Alive 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.
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Time frame: At 6 and 12 months
Percentage of Participants With EGFR Mutation at 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.
Time frame: Screening