NCT01460472

Immunotherapy With Racotumomab in Advanced Lung Cancer

A Prospective, Randomized, Multicenter, Open Label Phase III Study of Active Specific Immunotherapy With Racotumomab Plus Best Support Treatment Versus Best Support Treatment in Patients With Advanced Non-small Cell Lung Camcer.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,082 (estimated)
• Sponsor: Recombio SL · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, open label, parallel-group, multicenter phase III study to evaluate the efficacy and safety of active specific immunotherapy with racotumomab plus best supportive care versus best supportive care in patients with advanced NSCLC who have achieved an Objective Response (Partial or Complete Response) or Stable Disease with standard first-line treatment. Also immunological parameters will be evaluated. Best supportive therapy will be administered to all patients in the study according to institutional standards and includes any subsequent onco-specific therapies. 1082 patients will be included in the study, with non-small cell lung cancer in stages IIIA (non-resectable), IIIB or IV.

Conditions

• NSCLC
• Lung Cancer, Non-small Cell

Interventions

Type	Name	Description
BIOLOGICAL	Racotumomab	Patients will receive best support treatment and vaccination with racotumomab. The vaccination schedule is as follows: 5 doses (1mg/mL each), intradermally, every 2 weeks (induction period) followed by monthly vaccinations until any criteria for discontinuation are met. If disease progression occurs and further onco-specific therapy is indicated, the patient will be able to continue in the study and vaccination will not be interrupted unless criteria for vaccine discontinuation are met.
OTHER	Best Support Treatment	Patients will receive best support treatment for advanced NSCLC as per each institution's standards, including onco-specific therapies when disease progresses.

Timeline

• Start date: 2010-09-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2011-10-26
• Last updated: 2016-07-29

Locations

46 sites across 7 countries: Argentina, Brazil, Cuba, Indonesia, Philippines, Singapore, Thailand