Overview

Genius Study Study to Compare Efficacy and Safety of Gefitinib/ Pemetrexed With Pemetrexed Alone as Maintenance Therapy in Patients With Stage IV EGFR Mutation Negative or T790M Single Mutation Who Respond to Pemetrexed/ Platinum as First-line Thera

Status:
Unknown status

Trial end date:
2014-06-01

Target enrollment:

Participant gender:

Summary

The study aims to randomize 52 patients with advanced (Stage IV) EGFR mutation negative nonsquamous non-small cell lung cancer (NSCLC) who respond (CR/PR/SD) to 4 cycles of pemetrexed / cisplatin or pemetrexed/carboplatin as first-line therapy. In order to achieve that, approximately 144 treatment naïve patients with advanced nonsquamous NSCLC need to be enrolled from around 6 investigational sites in Taiwan that have expertise in lung cancer diagnosis.

Phase:

Phase 2/Phase 3

Details

Lead Sponsor:

Taipei Veterans General Hospital, Taiwan

Collaborators:

China Medical University Hospital
Dalin Tzu Chi General Hospital
National Taiwan University Hospital
Taichung Veterans General Hospital
Tri-Service General Hospital

Treatments:

Gefitinib
Pemetrexed