drugset / Trial / NCT01579630
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 Therapy
Phase 2/3
Unknown
52 enrolled
Taipei Veterans General Hospital, Taiwan
China Medical University Hospital · collabDalin Tzu Chi General Hospital · collabNational Taiwan University Hospital · collabTaichung Veterans General Hospital · collabTri-Service General Hospital (TSGH) · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2011-03
- Primary completion
- 2013-06
- Completion
- 2014-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gefitinib | Small molecule | 250 mg | — |
| Background | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |