NCT00923312

Trial of an RNActive®-Derived Cancer Vaccine in Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC)

Safety and Efficacy Phase I/IIa Trial of an RNActive®-Derived Cancer Vaccine in Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: CureVac · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I/IIa open, uncontrolled, international, prospective clinical trial, in an out-patient setting, in patients with stage IIIB/IV NSCLC. The phase I part of the study consists of a dose escalation phase, in which the recommended dose (RD) for the phase IIa part of the study will be established based on the incidence of dose-limiting toxicities (DLT). In the phase IIa part of the study, additional patients will be included at the RD, to confirm the safety and explore the activity of that dose. This study will take place in Switzerland (2 sites) and Germany (11 sites).

Detailed description

Medical Need: Lung cancer is the leading cause of cancer mortality in developed countries; about 87% of lung cancers are of the NSCLC type. Patients with more advanced but non-metastatic disease (IIIA or IIIB) usually undergo chemotherapy and/or radiation therapy, with or without secondary surgical resection. Patients with progression after chemotherapy and/or radiotherapy may receive second-line treatment with targeted therapies. Despite these aggressive treatments, only about 5% of patients with metastatic disease survive for 5 or more years. Given these dismal statistics, it is clear that new therapeutic approaches for treatment of NSCLC are urgently needed. Potential Benefits: CV9201 is an mRNA-based vaccine for the treatment of human NSCLC that is based on CureVac's RNActive® technology. As an mRNA-based vaccine, CV9201 features several advantages over other approaches: it is highly specific, there is no restriction to the patient's MHC genotype, and it does not need to cross the nuclear membrane to be active. Finally, in the absence of reverse transcriptase, RNA can not be integrated into the genome. For the planned first-in-man study, CV9201 will be administered in 5 doses. The phase I part of this phase I/IIa study is a dose finding study, to determine the RD for the phase IIa part.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	CV9201	CV9201 is a vaccine consisting of five drug product components. Treatment will be administered on 5 timepoints.

Timeline

• Start date: 2009-05-01
• Primary completion: 2012-02-01
• Completion: 2014-05-01
• First posted: 2009-06-18
• Last updated: 2018-03-20

Locations

14 sites across 2 countries: Germany, Switzerland