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Carcinoma, Non-Small-Cell LungPhase 2/3NCT00415818

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

A Phase 2/3 study testing MVA-MUC1-IL2 and 1st line Chemotherapy in people with Carcinoma, Non-Small-Cell Lung, run by Transgene at 23 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
MVA-MUC1-IL2 and 1st line Chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
148 participants
Where
23 sitesin 4 countries
Study dates
Dec 2005to Mar 2010
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

23 sites in 4 countries.

23 sites in 4 countries

France11 sites

  • Centre Hospitalier Belfort-Montbeliard

    Belfort, 90016

  • CHU, Service de Pneumologie

    Besançon, 25000

  • Centre Hospitalier Général, Service de Pneumologie

    Briey, 54151

  • Centre François Baclesse

    Caen, 14076

  • Hôpital Pasteur - Service de médecine F- Pavillon 43

    Colmar, 68000

  • Centre Oscar Lambret

    Lille, 59020

  • Institut Paoli-Calmettes, Service d'oncologie médicale

    Marseille, 13273

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHRU Hôpital de Pontchaillou

    Rennes, 35033

  • Hôpital Lyautey - Service de Pneumologie

    Strasbourg, 67100

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

    Vesoul, 70014

Other trials in France

Poland6 sites

  • Oddział II Chorób Płuc i Gruźlicy

    Bialystok, 15-540

  • Kujawsko-Pomorskie Centrum Pulmonologii

    Bydgoszcz, 85-326

  • Oddział Chemioterapii

    Krakow, 31-826

  • Oddział III Chorób Płuc i Gruźlicy

    Otwock, 05-400

  • Oddział Onkologii Klinicznej

    Poznan, 60-569

  • Dolnośląskie Centrum

    Wroclaw, 53-439

Other trials in Poland

Germany5 sites

  • Lungenklinik Krankenhaus Merheim

    Cologne, 51109

  • Asklepios Fachkliniken, Zentrum für Pneumonologie

    Gauting, 82131

  • Thoraxklinik Heidelberg

    Heidelberg, 69126

  • Klinikum Mannheim der Ruprecht-Karls

    Mannheim, 68167

  • Klinikum Offenburg, Medizinische Klinik II

    Offenburg, 77654

Other trials in Germany

Hungary1 site

  • Fejér Megyei Szent György Kórház

    Székesfehérvár, 8000

Other trials in Hungary

About this study

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

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.

Read the 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.

Being tested
MVA-MUC1-IL2, 1st line Chemotherapy
Keywords
Lung Cancer, NSCLC, Cancer Vaccine, Stage IV Non-Small Cell Lung Cancer, Stage IIIb Non-Small Cell Lung Cancer with effusion
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 1st line ChemotherapyDrug

Study groups in NCT00415818
Study groupRoleWhat they receive
Arm 1ExperimentalMVA-MUC1-IL2 in combination with 1st line Chemotherapy
Receives: Biological: MVA-MUC1-IL2; Drug: 1st line Chemotherapy
Arm 2Active comparator1st line Chemotherapy without a MVA-MUC1-IL2 combination
Receives: Drug: 1st line Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival at 6 months

    Measured: 6 months

Secondary outcomes (4)

  1. Response Rate according to WHO criteria

    Measured: 6 months

  2. Time to progression

    Measured: 6 months

  3. Overall survival

  4. Quality of life

    Measured: every 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Dec 2006 (estimated)
  2. Study startDec 2005
  3. Primary completionMar 2010
  4. Study completionMar 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
148 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00415818
Sponsor's protocol ID
TG4010.09
Status last verified
Jul 2014
First submitted
22 Dec 2006
Last updated
16 Jul 2014
Results posted
No

Publications

  • 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.

    PubMed 22019520

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing MVA-MUC1-IL2 and 1st line Chemotherapy in people with Carcinoma, Non-Small-Cell Lung, run by Transgene at 23 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in France, Poland, Germany, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00415818, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2014.

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