drugset / Trial / NCT00406302
Immune Response on Neoadjuvant Therapy in Non-small-cell Lung Cancer (NSCLC)
Phase 2
Completed
41 enrolled
Wolfgang Hilbe
Merck Sharp & Dohme LLC · collabSanofi · collabTAKO - Tiroler Arbeitskreis Onkologie · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Primary objective is to assess the overall response rate (ORR) after induction therapy with docetaxel in combination with CDDP and cetuximab in patients with NSCLC stage IB, II, and IIIa. ORR will be determined by the percentage of patients achieving objective response rates (CR + PR) according to the RECIST guidelines.
Timeline
- Start
- 2007-01
- Primary completion
- 2011-06
- Completion
- 2011-06
Publications
- Background Fossella F, Pereira JR, von Pawel J, Pluzanska A, Gorbounova V, Kaukel E, Mattson KV, Ramlau R, Szczesna A, Fidias P, Millward M, Belani CP. Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer: the TAX 326 study group. J Clin Oncol. 2003 Aug 15;21(16):3016-24. doi: 10.1200/JCO.2003.12.046. Epub 2003 Jul 1.
- Background Rosell R., et al. Proc Am Soc Clin Oncol 23: 618, 2004
- Background Betticher DC, et al. Proc Am Soc Clin Oncol: 1824, 1999
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | 250 mg/m2 | — |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 40 mg/m2 | — |