This trial is an extension to ENSURE, a study of erlotinib versus gemcitabine/cisplatin combination chemotherapy as the first-line treatment for patients with non-small-cell lung cancer (NSCLC) with mutations in the tyrosine kinase domain of EGFR. This study is designed to examine the efficacy of erlotinib versus gemcitabine/cisplatin as a second-line treatment in NSCLC patients from the ENSURE trial (NCT01342965). Patients previously treated with gemcitabine/cisplatin will be given erlotinib daily until disease progression or unacceptable toxicity occurs. Patients previously treated with erlotinib will be given cisplatin on Day 1 and gemcitabine on Days 1 and 8 of 3-week chemotherapy cycles until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
150 mg oral dose of erlotinib given once daily
Cisplatin (75 mg/m\^2 intravenously \[IV\]) on Day 1 and gemcitabine (1250 mg/m\^2 IV) on Days 1 and 8 of 3-week chemotherapy cycles until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first)
Unnamed facility
Beijing, China
Unnamed facility
Changchun, China
Unnamed facility
Chongqing, China
Unnamed facility
Chongqing, China
Unnamed facility
Fuzhou, China
Unnamed facility
Guangzhou, China
Unnamed facility
Nanjing, China
Unnamed facility
Shanghai, China
Unnamed facility
Shanghai, China
Unnamed facility
Shantou, China
...and 1 more locations
Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events
Progression free survival is defined as the time of randomization in ENSURE study to progressive disease (PD) while on second-line treatment or death from any cause, whichever occurred first during the second-line treatment.
Time frame: within 3 years, 9 months (data cut-off December 2014)
Participants With Adverse Events
Time frame: start of second-line treatment to data cut-off in December 2014 (within 12 months)
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