Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004429

Trial Description

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Title

GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resectable MAGE-A3 Positive Non-Small Cell Lung Cancer

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this clinical trial is to demonstrate the benefit of the immunotherapeutic
product GSK1572932A when given to patients with Non-Small Cell Lung Cancer, after removal of
their tumor. A course of 13 injections will be administered over 27 months. The Protocol
Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

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Brief Summary in Scientific Language

"http://www.immunotherapyforcancer.info provides information on the cancer immunotherapeutic
approach in an easy-to-understand format" "http://www.ascitrials.com gives practical
information on the MAGRIT clinical study"

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Organizational Data

  •   DRKS00004429
  •   2012/10/05
  •   2007/05/29
  •   no
  •   [---]*
  •   [---]*
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Secondary IDs

  •   NCT00480025  (ClinicalTrials.gov)
  •   109493  (GlaxoSmithKline)
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Health Condition or Problem studied

  •   Lung Cancer, Non-Small Cell
  •   C34 -  Malignant neoplasm of bronchus and lung
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Interventions/Observational Groups

  •   Biological: GSK1572932A Antigen-Specific Cancer Immunotherapeutic
  •   Biological: Placebo Control
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- Disease-free survival; time frame: At predefined time points

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Secondary Outcome

- Overall survival; time frame: At predifined time points
- Lung-cancer-specific survival; time frame: At predifined time points
- Disease-free survival at 2, 3, 4 and 5 year; time frame: After predifined time points
- Disease-free specific survival; time frame: At predifined time points
- Anti-MAGE-A3 and anti-protein D seropositivity rate. Seropositivity will be assessed at baseline, after 2, 4, 6, 7 and 9 administrations; time frame: At predifined time points
- Occurrence of adverse events, including abnormal hematological and biochemical parameters; time frame: At predifined time points
- Occurrence of serious adverse events; time frame: At predifined time points

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Countries of Recruitment

  •   United States
  •   Argentina
  •   Australia
  •   Austria
  •   Belgium
  •   Brazil
  •   Canada
  •   China
  •   Czech Republic
  •   Estonia
  •   Finland
  •   France
  •   Germany
  •   Greece
  •   Hong Kong
  •   Hungary
  •   India
  •   Ireland
  •   Israel
  •   Italy
  •   Japan
  •   Korea, Republic of
  •   Netherlands
  •   Norway
  •   Poland
  •   Russian Federation
  •   Singapore
  •   Spain
  •   Sweden
  •   Switzerland
  •   Taiwan, Province of China
  •   Thailand
  •   Ukraine
  •   United Kingdom
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2007/10/31
  •   2270
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Inclusion criteria:

- Male or female patient with completely resected, pathologically proven stage IB, II
or IIIA NSCLC.

- Written informed consent for MAGE-A3 expression screening on tumor biopsy has been
obtained from the patient prior to shipment of the sample for expression testing
(before or just after surgical resection), and written informed consent for the
complete study has been obtained prior to the performance of any other
protocol-specific procedure.

- Patient is ≥ 18 years of age at the time of signature of the first informed consent
form.

- The patient's tumor shows expression of MAGE-A3 gene

- The surgical technique for resection of the patient's tumor is anatomical, involving
at least a lobectomy or a sleeve lobectomy;

- The mediastinal lymph node sampling is done according to study protocol guidelines;

- The patient is free of metastasis, as confirmed by a negative baseline computer
tomogram (CT scan) of the chest, upper abdomen and CT scan or MRI of the brain.

Other examinations should be performed as clinically indicated. Note that if randomization
is taking place within 8 weeks after surgery, brain CT scans or brain MRI performed up to
4 weeks before surgery do not have to be repeated.

- ECOG performance status of 0, 1 or 2 at the time of randomization.

- Adequate bone-marrow reserve, adequate renal function and adequate hepatic function
as assessed by standard laboratory criteria, and defined as:

Absolute neutrophil count ≥ 1.0 x 10E9/L Platelet count ≥ 75 x 10E9/L Serum creatinine ≤
1.5 times the Upper Limit of Normal (ULN)

≤ 3.0 times the ULN if due to platinum adjuvant chemotherapy Total bilirubin ≤ 1.5 times
the ULN Alanine transaminase (ALAT) ≤ 2.5 times the ULN

- If the patient is female, she must be of non-childbearing potential, i.e. have a
current tubal ligation, hysterectomy, ovariectomy or be post menopausal, or if she is
of childbearing potential, she must practice adequate contraception for 30 days prior
to administration of study treatment, have a negative pregnancy test and continue
such precautions during all study treatment period and for 2 months after completion
of the injection series.

- In the view of the investigator, the patient can and will comply with the
requirements of the protocol.

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Exclusion Criteria

Exclusion criteria

- The primary tumor was removed by segmentectomy or wedge resection.

- The patient shows any evidence of residual tumor after surgery.

- The patient has received any anti-cancer specific treatment, including radiotherapy,
immunotherapy, chemotherapy or neo-adjuvant chemotherapy, except:

For the treatment of previous malignancies as allowed by the protocol (i.e., non-melanoma
skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has
been in remission for over 5 years), Administration of adjuvant platinum-based
chemotherapy for the treatment of the current NSCLC is allowed between surgery and
randomization.

- The patient has previous or concomitant malignancies at other sites, except
effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or
effectively treated malignancy that has been in remission for over 5 years and highly
likely to have been cured.

- History of allergic disease or reactions likely to be exacerbated by any component of
the study investigational product.

- The patient has an autoimmune disease such as, but not limited to, multiple
sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not
excluded.

- The patient requires concomitant treatment with systemic corticosteroids, or any
other immunosuppressive agents.

Note: The use of prednisone, or equivalent, <0.5 mg/kg/day (absolute maximum 40 mg/day),
or inhaled corticosteroids for COPD or topical steroids is permitted.

- The patient has received a major organ allograft.

- The patient is known to be HIV-positive.

- The patient has an uncontrolled bleeding disorder.

- The patient has uncontrolled congestive heart failure or hypertension, unstable heart
disease (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia
at the time of enrolment.

- The patient needs home oxygenation.

- The patient has psychiatric or addictive disorders that may compromise his/her
ability to give informed consent, or to comply with the trial procedures.

- The patient has other concurrent severe medical problems, unrelated to the
malignancy, that would significantly limit full compliance with the study or expose
the patient to unacceptable risk.

- The patient has received any investigational or non-registered medicinal product
other than the study medication within the 30 days preceding the first dose of study
medication, or plans to receive such a drug during the study period.

- For female patients: the patient is pregnant or lactating.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • GlaxoSmithKline
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    •   [---]*
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  • start of 1:1-Block address scientific-contact
    • GlaxoSmithKline
    • GSK Clinical Trials 
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    • GlaxoSmithKline
    • GSK Clinical Trials 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   6
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.