This single arm study will assess the efficacy and safety of erlotinib + gemcitabine in chemotherapy-naive participants with unresectable, advanced and/or metastatic non-small cell lung cancer. Participants will receive erlotinib 150 mg orally (po) daily, in combination with gemcitabine 1000 mg/m\^2 intravenously (iv) weekly for 3 weeks of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
150 mg po daily
1000 mg/m\^2 iv on days 1, 8, 15 of each 4 week cycle for 6 cycles
Unnamed facility
Bucharest, Romania
Time to Disease Progression
Time to disease progression or progression free survival (PFS) was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first.
Time frame: From the time of randomization until disease progression or death (up to 193 weeks)]
Overall Response Rate (ORR)
Overall response rate was defined as the percentage of participants who had any evidence of confirmed objective complete response (CR) or partial response (PR), per the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) and assessed by computed tomography imaging (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: From the time of randomization until disease progression or death (up to 193 weeks)
Overall Survival
Overall survival was defined as the interval between the day of randomization and the date of death from any cause.
Time frame: From the time of randomization until death (up to 193 weeks)
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