NCT00633529

Safety of Adding IMO-2055 to Erlotinib + Bevacizumab in 2nd Line Treatment for Patients With NSCLC

Open-Label Phase 1b Study of Erlotinib Plus Bevacizumab and IMO-2055 in Patients With Non-Small Cell Lung Cancer Who Have Progressed Following Initial Chemotherapy for Advanced or Metastatic Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: EMD Serono · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety of the proposed Phase II dosage of the investigational drug IMO 2055 when combined with erlotinib and bevacizumab in patients with previously treated advanced NSCLC.

Detailed description

Phase 1b study of escalating doses of weekly subcutaneous IMO-2055 combined with fixed standard dose regimens of oral erlotinib (daily) and IV bevacizumab (every 3 weeks) in patients with previously treated advanced NSCLC.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	IMO-2055	0.08, 0.16, or 0.32 mg/kg SC (subcutaneous) on days 1,8,and 15 of every 21 day cycle until evidence of progressive disease, unacceptable treatment-related toxicities, withdrawal of patient consent and/or Investigator decision to withdraw study therapy with documented reason, whichever occurs first.

Timeline

• Start date: 2007-11-01
• Primary completion: 2010-10-01
• Completion: 2011-03-01
• First posted: 2008-03-12
• Last updated: 2013-10-22

Locations

9 sites across 1 country: United States