A Single-Arm, Phase 2 Trial of Pemetrexed, Cisplatin,and Bevacizumab as Induction, Followed by Pemetrexed and Bevacizumab as Maintenance, in First-Line Treatment of Nonsquamous Advanced NSCLC
The study will have 3 periods: a baseline period; a study treatment period, including both
induction and maintenance treatment; and a postdiscontinuation period. Approximately 110
participants will be enrolled into the study, with the aim of having 100 evaluable
participants. Eligible participants will first receive 4 cycles of induction chemotherapy
with pemetrexed-cisplatin-bevacizumab. Participants who achieve a response or do not
progress after completion of induction chemotherapy and have an adequate performance status
will receive maintenance therapy with pemetrexed-bevacizumab. Treatment will continue until
disease progression or unacceptable toxicity occurs. When treatment is discontinued, the
participants health status will be monitored till death, loss to follow-up or data cut-off
date.
Participants who continue to receive benefit from treatment at the time of data cut-off may
receive continued access to pemetrexed and bevacizumab until disease progression,
unacceptable toxicity, or any other reason at investigator or participants decision.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free Survival
From enrollment to the first date of objectively determined Progressive disease or death from any cause (every other cycle during study treatment, and then every 6 weeks during follow-up period)
No
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Study Director
Eli Lilly and Company
Denmark: Danish Medicines Agency
13034
NCT01004250
October 2009
December 2013
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