Advanced Non-Small Cell Lung Cancer Clinical Trial
Official title:
An Open-Label, Non-Randomized, Multicenter, Three Stage, Phase 2 Study of S-1 as 2nd Line Therapy for Patients With Advanced Non-Small Cell Lung Cancer (Stage IIIB/Stage IV)
The purpose of this study is to determine whether S-1 is effective as 2nd line therapy in slowing tumor activity in patients with advanced non-small cell lung cancer. The study is also looking at the safety of S-1.
Advanced non-small cell lung cancer is relatively unresponsive to chemotherapy. This is true
for the nucleoside analogue gemcitabine, with a response rate of approximately 10%, as well
as for 5-fluorouracil (5-FU). Even when gemcitabine is combined with other chemotherapeutic
drugs or biological agents, the overall tumor response rate remains basically unchanged. S-1
is a new generation oral fluoropyrimidine that combines Tegafur
(5-fluoro-1-(tetrahydro-2-furanyl)-2,4(1H,3H)-pyrimidinedione [FT]), an oral prodrug of
5-FU, with two modulators, Gimeracil (5-chloro-2,4-dihydroxypyridine [CDHP]), which inhibits
5-FU degradation by dihydropyrimidine dehydrogenase (DPD) inhibition, and Oteracil potassium
(Oxo), which inhibits 5-FU phosphorylation in the digestive tract. This combination of 3
compounds is designed to achieve enhanced antitumor activity while decreasing
gastrointestinal toxicity.
This is an open-label, multicenter, single-arm, 3-stage, Phase 2 study evaluating the
efficacy and safety of single agent S-1 as 2nd line therapy for patients with advanced
NSCLC. The 3 stages of this study correspond to a futility stage (stage 1), a decision stage
(stage 2), and a stage for improvement of precision of ORR (stage 3).
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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