First-Line Chemotherapy and Panitumumab in Advanced Non-Small Cell Lung Cancer (Lung-TRIO)
- Very low enrollment rate.
- Recent studies question the effect of adding panitumumab in this category of patients.
- Too high toxicity rate
The purpose of this study is to determine whether the addition of panitumumab to standard chemotherapy in first-line treatment of advanced Non Small Cell Lung Cancer improves the treatment outcome. Patients are selected based on triple mutational status.
Non Small Cell Lung Cancer
|Study Design:||Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of First-Line Chemotherapy and Panitumumab in Advanced NSCLC Selected by Mutational Status|
- Response rate [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- Progression free survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Up to 3 years. ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Study Completion Date:||December 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Advanced NSCLC holds a very poor prognosis with a moderate response rate to standard chemotherapy. The standard first-line treatment for advanced NSCLC is platinum based combination chemotherapy. The response rates are less than 30% and a substantial amount of patients will experience unnecessary toxicity in terms of e.g. nausea, vomiting, neuropathies or a considerable risk of renal toxicity. The median progression free survival is 3-4 months and consequently, the median overall survival is less than one year (Hotta et al 2007). Addition of new biological agents to standard chemotherapy regimens may improve the outcome for these patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038037
|Vejle, Denmark, DK-7100|