Spots Global Cancer Trial Database for Trial of RNActive®-Derived Cancer Vaccine and Local Radiation in in Stage IV Non Small Cell Lung Cancer (NSCLC)
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Trial Identification
Brief Title: Trial of RNActive®-Derived Cancer Vaccine and Local Radiation in in Stage IV Non Small Cell Lung Cancer (NSCLC)
Official Title: An Exploratory, Open-label Phase Ib Study of RNActive®-Derived Cancer Vaccine and Local Radiation as Consolidation and Maintenance Treatment in Patients With Stage IV NSCLC and a Response or Stable Disease After First-line Chemotherapy or Therapy With an EGFR Tyrosine Kinase Inhibitor
Study ID: NCT01915524
Conditions
Study Description
Brief Summary: The purpose of this study is to determine whether the new RNActive derived lung cancer vaccine CV9202 in combination with local radiation therapy is safe, tolerable and immunogenic for the consolidation and maintenance treatment of stage IV non small cell lung cancer (NSCLC) after first-line chemotherapy or therapy with an EGFR tyrosine kinase inhibitor.
Detailed Description: The Phase Ib study is the first clinical study with the new lung cancer vaccine CV9202. The vaccine is composed of 6 RNActive compounts, each encoding for a different antigen which is overexpressed in NSCLC compared to healthy tissue. In order to enhance the immunogenic effect of the cancer vaccine, the study treatment will include local radiation (4 x 5 Gy), which is a well-established palliative radiation regimen that can be safely applied to metastatic lesions in the lung, bone, and soft tissue, and is well tolerated. Patients will be enrolled into 3 strata based on histologic and molecular subtypes as follows: Stratum 1: Patients with metastatic stage IV NSCLC and non-squamous histology, without activating epidermal growth factor receptor (EGFR) mutations, who have achieved partial response (PR) or stable disease (SD) after at least 4 cycles of platinum- and pemetrexed-based first-line chemotherapy, and an indication for maintenance therapy with pemetrexed. Stratum 2: Patients with stage IV NSCLC and squamous cell histology, who achieved PR or SD after at least 4 cycles of platinum-based and non-platinum compound first-line chemotherapy. Stratum 3: Patients with stage IV NSCLC and non-squamous histology, harboring an activating EGFR mutation, who have achieved PR after up to 6 months or SD after 3 - 6 months of treatment with an EGFR TKI. In each patient, the vaccine will be administered until progression and the need to start a subsequent systemic second-line treatment, or occurrence of unacceptable toxicity requiring treatment discontinuation, whichever comes first.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Innsbruck Medical University, Department of Internal Medicine V (Hematology and Oncology), Innsbruck, , Austria
HELIOS Klinikum Emil von Behring GmbH, Berlin, , Germany
Augusta-Kranken-Anstalt gGmbH, Bochum, , Germany
Kliniken der Stadt Köln gGmbH, Cologne, , Germany
Klinikum Esslingen GmbH, Esslingen, , Germany
University Hospital Frankfurt, Department of Medicine II: Hematology/Oncology, Frankfurt, , Germany
Thoraxklinik-Heidelberg gGmbH, Heidelberg, , Germany
University Medical Center Mainz, III. Medical Clinic and Policlinic, Mainz, , Germany
Pius-Hospital Oldenburg, Oldenburg, , Germany
University Hospital Basel, Clinic for Oncology, Basel, , Switzerland
Kantonsspital Graubünden, Chur, , Switzerland
Kantonspital St. Gallen, St. Gallen, , Switzerland
Kantonspital Winterthur, Oncology, Winterthur, , Switzerland
Contact Details
Name: Alfred Zippelius, Prof. Dr.
Affiliation: University Hospital Basel, Clinic for Medical Oncology
Role: PRINCIPAL_INVESTIGATOR
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