Know Cancer

forgot password

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

Phase 2/Phase 3
18 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

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

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.

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,

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival at 6 months

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Elisabeth QUOIX, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H├┤pital Lyautey, Service de Pneumologie


United States: Food and Drug Administration

Study ID:




Start Date:

December 2005

Completion Date:

December 2009

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Lung Cancer
  • Cancer Vaccine
  • Stage IV Non-Small Cell Lung Cancer
  • Stage IIIb Non-Small Cell Lung Cancer with effusion
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms