drugset / Trial / NCT02405910
Ph2 Nab-paclitaxel With Gemcitabine to Determine Efficacy in Advanced Non-squamous NSCLC.
RandomizedParallel-groupOpen-labelTreatment
Summary
Phase II study to determine progression free survival (PFS) of nab-paclitaxel administered in combination with gemcitabine, at two different dose combinations as first line therapy in patients with unresectable stage IIIB/stage IV non-squamous non-small cell lung cancer (NSCLC).
Timeline
- Start
- 2015-03-15
- Primary completion
- 2017-12
- Completion
- 2023-04
Outcome
Outcome not reported
Stopped: “PI Left Institution”
Publications
- Background D'Addario G, Pintilie M, Leighl NB, Feld R, Cerny T, Shepherd FA. Platinum-based versus non-platinum-based chemotherapy in advanced non-small-cell lung cancer: a meta-analysis of the published literature. J Clin Oncol. 2005 May 1;23(13):2926-36. doi: 10.1200/JCO.2005.03.045. Epub 2005 Feb 22.
- Background Jiang J, Liang X, Zhou X, Huang R, Chu Z, Zhan Q. Non-platinum doublets were as effective as platinum-based doublets for chemotherapy-naive advanced non-small-cell lung cancer in the era of third-generation agents. J Cancer Res Clin Oncol. 2013 Jan;139(1):25-38. doi: 10.1007/s00432-012-1294-z. Epub 2012 Aug 5.
- Background Davidoff AJ, Tang M, Seal B, Edelman MJ. Chemotherapy and survival benefit in elderly patients with advanced non-small-cell lung cancer. J Clin Oncol. 2010 May 1;28(13):2191-7. doi: 10.1200/JCO.2009.25.4052. Epub 2010 Mar 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1250 mg/m2 | Intravenous |
| Subject | Nab-paclitaxel | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Nab-paclitaxel | Small molecule | 125 mg/m2 | Intravenous |