Brief Summary

The primary Objective is to assess the efficacy of TG4010 combined to chemotherapy in comparison with chemotherapy alone in patients with advanced non small cell lung cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

148

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Dec 2005

Typical duration for phase_2

Geographic Reach

4 countries

23 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.2 years study duration

Study Start

First participant enrolled

December 1, 2005

Completed

1.1 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2006

Completed

3 days until next milestone

First Posted

Study publicly available on registry

December 25, 2006

Completed

3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed

Last Updated

July 16, 2014

Status Verified

July 1, 2014

Enrollment Period

4.2 years

First QC Date

December 22, 2006

Last Update Submit

July 15, 2014

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Lung CancerNSCLCCancer VaccineStage IV Non-Small Cell Lung CancerStage IIIb Non-Small Cell Lung Cancer with effusion

Outcome Measures

Primary Outcomes (1)

Progression free survival at 6 months
6 months

Secondary Outcomes (4)

Response Rate according to WHO criteria
6 months
Time to progression
6 months
Overall survival
Quality of life
every 6 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

MVA-MUC1-IL2 in combination with 1st line Chemotherapy

Biological: MVA-MUC1-IL2Drug: 1st line Chemotherapy

Arm 2

ACTIVE COMPARATOR

1st line Chemotherapy without a MVA-MUC1-IL2 combination

Drug: 1st line Chemotherapy

Interventions

MVA-MUC1-IL2BIOLOGICAL

MVA-MUC1-IL2: Dose of 10exp8 plaque forming units (pfu). Chemotherapy: Arm 1 and Arm 2 Intravenous CT: cisplatin (75mg/m² at Day 1) and gemcitabine (1250mg/m² at Days 1 and 8) every 3 weeks, for up to six cycles or until progressive disease, whichever occurred first.

Arm 1

1st line ChemotherapyDRUG

Arm 1Arm 2

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histologically confirmed non-small cell carcinoma of the lung (adenocarcinoma, squamous cell carcinoma, or large cell carcinoma);
Histological documentation of MUC1 antigen expression on the primary tumor or on metastasis, as defined by a positive staining by immuno-histo-chemistry in at least 25% of the tumor cells in the conditions described in the technical documentation of the monoclonal antibody;
Patients will have stage IIIb "wet" (with pleural or pericardial effusion) or IV disease, with no prior systemic therapy for advanced disease except for adjuvant treatment. Prior surgery or radiation therapy aimed at local palliation or attempted local disease control is permitted;
At least one measurable lesion by Computed Tomography (CT-scanner) according to WHO criteria (lesion accurately measured in two dimensions with longest diameter equal or greater to 10 mm with spiral CT scan);
Adequate hematological, hepatic, and renal function:
Hemoglobin \>= 10.0 g/dL; WBC \>= 3.0x10e9/L including neutrophils \>= 1.5x10e9/L and total lymphocytes count \>= 0.5x10e9/L; platelets count \>= 100x10e9/L;
Bilirubin =\< 2x the upper limit of normal and serum transaminases =\< 3x the upper limit of normal;
Glomerular Filtration Rate higher than 60 ml/mn according to Cockcroft formula;
Performance status 0 or 1 on the ECOG scale (Appendix 2);
Minimum estimated life expectancy of 4 months;
Written informed consent from patient.

You may not qualify if:

Concomitant brain metastases. If previous brain metastases were treated, the absence of evolution is to be demonstrated by the MRI or scanner performed at baseline;
Prior history of other malignancy except basal cell carcinoma and intra-epithelial cervical cancer or other cancer with complete response since at least 5 years;
History of any form of systemic therapy for advanced non-small cell cancer of the lung except for (neo)adjuvant treatment;
Previous (within 4 weeks prior to day 1) or concomitant long term treatment with systemic steroids, immunosuppressive / immunomodulating drugs (e.g. Cyclosporine, corticoïds);
Positive serology for HIV or HCV; positive antigens for hepatitis B;
Serious concomitant medical disorder;
Major surgery within 4 weeks prior to day 1;
Patient with an organ allograft;
Allergy to eggs;
Participation in another experimental protocol during the study period, or within 4 weeks prior to day 1;
Pregnancy at the entry or women who are breast feeding;
Patient without adequate protection against pregnancy during the conduct of the study and for 3 months after the last injection of TG4010 and/or chemotherapy;
History of substance abuse;
Patient unable or unwilling to comply with the protocol requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Transgenelead

Study Sites (23)

Centre Hospitalier Belfort-Montbeliard

Belfort, 90016, France

Location

CHU, Service de Pneumologie

Besançon, 25000, France

Location

Centre Hospitalier Général, Service de Pneumologie

Briey, 54151, France

Location

Centre François Baclesse

Caen, 14076, France

Location

Hôpital Pasteur - Service de médecine F- Pavillon 43

Colmar, 68000, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Institut Paoli-Calmettes, Service d'oncologie médicale

Marseille, 13273, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

CHRU Hôpital de Pontchaillou

Rennes, 35033, France

Location

Hôpital Lyautey - Service de Pneumologie

Strasbourg, 67100, France

Location

Centre Hospitalier de la Haute Saône, Service de Pneumologie - Allergologie

Vesoul, 70014, France

Location

Lungenklinik Krankenhaus Merheim

Cologne, 51109, Germany

Location

Asklepios Fachkliniken, Zentrum für Pneumonologie

Gauting, 82131, Germany

Location

Thoraxklinik Heidelberg

Heidelberg, 69126, Germany

Location

Klinikum Mannheim der Ruprecht-Karls

Mannheim, 68167, Germany

Location

Klinikum Offenburg, Medizinische Klinik II

Offenburg, 77654, Germany

Location

Fejér Megyei Szent György Kórház

Székesfehérvár, 8000, Hungary

Location

Oddział II Chorób Płuc i Gruźlicy

Bialystok, 15-540, Poland

Location

Kujawsko-Pomorskie Centrum Pulmonologii

Bydgoszcz, 85-326, Poland

Location

Oddział Chemioterapii

Krakow, 31-826, Poland

Location

Oddział III Chorób Płuc i Gruźlicy

Otwock, 05-400, Poland

Location

Oddział Onkologii Klinicznej

Poznan, 60-569, Poland

Location

Dolnośląskie Centrum

Wroclaw, 53-439, Poland

Location

Related Publications (1)

Quoix E, Ramlau R, Westeel V, Papai Z, Madroszyk A, Riviere A, Koralewski P, Breton JL, Stoelben E, Braun D, Debieuvre D, Lena H, Buyse M, Chenard MP, Acres B, Lacoste G, Bastien B, Tavernaro A, Bizouarne N, Bonnefoy JY, Limacher JM. Therapeutic vaccination with TG4010 and first-line chemotherapy in advanced non-small-cell lung cancer: a controlled phase 2B trial. Lancet Oncol. 2011 Nov;12(12):1125-33. doi: 10.1016/S1470-2045(11)70259-5. Epub 2011 Oct 21.
PMID: 22019520RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

Elisabeth QUOIX, M.D.
Hôpital Lyautey, Service de Pneumologie
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 22, 2006

First Posted

December 25, 2006

Study Start

December 1, 2005

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

July 16, 2014

Record last verified: 2014-07

Locations

DE(5)FR(11)HU(1)PL(6)

Immunotherapy With TG4010 in Patients With Advanced Non-Small Cell Lung Cancer

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Arm 1

Arm 2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (23)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Arm 1

Arm 2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (23)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations