NCT01088620

Panitumumab Plus Pemetrexed and Cisplatin (PemCisP) Versus PemCis in the First-line Treatment of Patients With Non-small Cell Lung Cancer

CHAMP - An Open-label, Randomised, Multicentre, Phase II Clinical Study of Panitumumab Plus Pemetrexed and Cisplatin (PemCisP) Versus PemCis in the First-line Treatment of Patients With Stage IIIB or IV Primary Nonsquamous Non-small Cell Lung Cancer, With Particular Regard to the KRAS Status

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: WiSP Wissenschaftlicher Service Pharma GmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to estimate the therapeutic efficacy of the experimental targeted regimen including the EGFR antibody panitumumab (in combination with pemetrexed and cisplatin) in relation to the standard combination in patients with a KRAS wild-type stage IIIB or IV primary nonsquamous non-small cell lung cancer. It is expected that the progression free survival rate at 6 months is improved by the targeted regimen.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Panitumumab	Panitumumab 9 mg/kg BW will be administered IV every 3 weeks (q3w) for a maximum of four cycles. In case of CR, PR or SD status at the end of the combination treatment, a panitumumab single drug treatment, consisting of 9 mg/kg BW administered every 3 weeks, will be performed until detection of disease progression.
DRUG	Pemetrexed	Pemetrexed 500 mg/m² will be administered IV every 3 weeks (q3w) for a maximum of four cycles.
DRUG	Cisplatin	Cisplatin 75 mg/m² will be administered IV every 3 weeks (q3w) for a maximum of four cycles.

Timeline

• Start date: 2010-04-01
• Primary completion: 2013-01-01
• Completion: 2014-01-01
• First posted: 2010-03-17
• Last updated: 2013-03-14

Locations

20 sites across 1 country: Germany