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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00415818
Recruitment Status : Completed
First Posted : December 25, 2006
Last Update Posted : July 16, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Biological: MVA-MUC1-IL2 Drug: 1st line Chemotherapy Phase 2 Phase 3

Detailed Description:

In the experimental arm patients receive subcutaneous injections of TG4010 at the dose of 108 pfu in combination with chemotherapy treatment whereas patients in the control arm receive chemotherapy alone. The chemotherapy associates cisplatin and gemcitabine and is given for up to 6 cycles or progressive disease, whichever occurs first.

TG4010 is administered once per week for 6 weeks, then once every 3 weeks in combination with chemotherapy and thereafter as monotherapy until documentation of progressive disease.

Tumor response will be evaluated every 6 weeks by a CT-scan and results will be available before starting an additional treatment period of 6 weeks. The tumor response taken into account will be for each patient the best overall response obtained during the study.

The endpoint of the study is based on Progression Free Survival (PFS) at 6 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IIb Multicentric Controlled Study Evaluating the Therapeutic Vaccine TG4010(MVA-MUC1-IL2) as an Adjunct to Standard Chemotherapy in Advanced Non Small Cell Lung Cancer
Study Start Date : December 2005
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Arm 1
MVA-MUC1-IL2 in combination with 1st line Chemotherapy
Biological: MVA-MUC1-IL2


Dose of 10exp8 plaque forming units (pfu).


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.

Drug: 1st line Chemotherapy
Active Comparator: Arm 2
1st line Chemotherapy without a MVA-MUC1-IL2 combination
Drug: 1st line Chemotherapy

Primary Outcome Measures :
  1. Progression free survival at 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Response Rate according to WHO criteria [ Time Frame: 6 months ]
  2. Time to progression [ Time Frame: 6 months ]
  3. Overall survival
  4. Quality of life [ Time Frame: every 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00415818

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Sponsors and Collaborators
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Principal Investigator: Elisabeth QUOIX, M.D. Hôpital Lyautey, Service de Pneumologie
Additional Information:
Publications of Results:
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Responsible Party: Transgene Identifier: NCT00415818    
Other Study ID Numbers: TG4010.09
First Posted: December 25, 2006    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014
Keywords provided by Transgene:
Lung Cancer
Cancer Vaccine
Stage IV Non-Small Cell Lung Cancer
Stage IIIb Non-Small Cell Lung Cancer with effusion
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms