Non-Small Cell Lung Cancer Clinical Trial
Official title:
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
Participants with advanced non-small cell lung cancer (NSCLC) will receive a first-line treatment of Pemetrexed, Cisplatin and Bevacizumab as induction therapy followed by a maintenance treatment of Pemetrexed and Bevacizumab. Treatment will continue until disease progression or unacceptable toxicity occurs. The primary objective of this study is to measure how long this treatment could prevent the disease progression.
The study will have 3 periods: a baseline period; a study treatment period, including both
induction and maintenance treatment; and a follow-up 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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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