NCT00536640

Inoperable Non-Squamous NSCLC Stage III/IV: A Randomised Phase II Study With Bevacizumab Plus Erlotinib Or Gemcitabine/Cisplatin Plus Bevacizumab

Inoperable Non-Squamous NSCLC Stage III/IV: A Randomised Phase II Study With Bevacizumab Plus Erlotinib Or Gemcitabin/Cisplatin Plus Bevacizumab

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Aktion Bronchialkarzinom e.V. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study wants to determine the activity of a non chemotherapy first line biological treatment with Erlotinib/Bevacizumab or Gemcitabine-Cisplatin/Bevacizumab in patients with the diagnosis of non-squamous advanced Non Small Lung Cancer.

Detailed description

Prospective, randomized multi-center, open label phase II study to determine the activity of a non-chemotherapy first line biological treatment with Erlotinib/Bevacizumab or Gemcitabine-Cisplatin/Bevacizumab in patients with the diagnosis of non-squamous advanced Non-Small-Lung-Cancer. * Duration of treatment/patient: up to 1,5 years * Follow Up: ≈ 6 month * Planned number of patients: 220 treated patients (110 patients/arm)

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Erlotinib	150 mg per os, given daily until tumor progression
DRUG	Bevacizumab	15mg/kg i.v. on day 1 (three-week cycle) until tumor progression
DRUG	Gemcitabine	1250 mg/2 i.v. on day 1 and day 8 (three-week cycle) until tumor progression for a maximum of 6 cycles
DRUG	Cisplatin	80 mg/m2 i.v. on day 1 (three-week cycle) until tumor progression for a maximum of 6 cycles. (The administration of 40 mg/2 Cisplatin on day 1 and day 8 is also possible)

Timeline

• Start date: 2007-11-01
• Primary completion: 2011-08-01
• Completion: 2012-05-01
• First posted: 2007-09-28
• Last updated: 2013-06-12

Locations

37 sites across 1 country: Germany