drugset / Trial / NCT01209520
Residual Hypermethylation in Early Stage Non-Small Cell Lung Cancer (NSCLC) As Part of Adjuvant Therapy and Preventive Strategy
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The trial investigates the feasibility and efficacy of targeting Non-Small Cell Lung Cancer (NSCLC) "driven" by epigenetic changes. The investigators study the impact of 5-azacitidine (Vidaza®, Celgene, Summit, NJ, USA) in combination with conventional cytotoxic chemotherapy in a sequential fashion. The study population consists of all NSCLC patients who undergo "curative" lung cancer resection and whose tumors harbor hypermethylation in any of the protocol-specific genes (samples will be banked for additional molecular testing including other 21 loci which have shown to be important in lung carcinogenesis.
Timeline
- Start
- 2009-07
- Primary completion
- 2013-12
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | Intravenous |
| Background | Carboplatin | Small molecule | — | — |
| Background | Cisplatin | Other / unclassified | — | — |
| Background | Docetaxel | Small molecule | — | — |
| Background | Paclitaxel | Small molecule | — | — |
| Background | Pemetrexed | Small molecule | — | — |
| Background | Vinorelbine | Small molecule | — | — |