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GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With 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: NCT00480025
Recruitment Status : Terminated (The study was terminated following assessment of the lack of efficacy of the study product by the Independent Data monitoring Committee for the study.)
First Posted : May 30, 2007
Last Update Posted : December 21, 2015
Information provided by (Responsible Party):

May 29, 2007
May 30, 2007
December 21, 2015
October 2007
December 2013   (Final data collection date for primary outcome measure)
Disease-free survival [ Time Frame: At predefined time points ]
Disease-free survival
Complete list of historical versions of study NCT00480025 on Archive Site
  • 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 ]
  • Overall survival, lung cancer-specific survival, disease-free specific survival
  • Safety
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GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung Cancer
GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resectable MAGE-A3 Positive Non-Small Cell Lung Cancer
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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Lung Cancer, Non-Small Cell
  • Biological: GSK1572932A Antigen-Specific Cancer Immunotherapeutic
    Intramuscular administration, 13 doses
  • Biological: Placebo Control
    Intramuscular administration, 13 doses
  • Experimental: ASCI Group
    Intervention: Biological: GSK1572932A Antigen-Specific Cancer Immunotherapeutic
  • Placebo Comparator: Placebo Group
    Intervention: Biological: Placebo Control
Vansteenkiste JF, Cho BC, Vanakesa T, De Pas T, Zielinski M, Kim MS, Jassem J, Yoshimura M, Dahabreh J, Nakayama H, Havel L, Kondo H, Mitsudomi T, Zarogoulidis K, Gladkov OA, Udud K, Tada H, Hoffman H, Bugge A, Taylor P, Gonzalez EE, Liao ML, He J, Pujol JL, Louahed J, Debois M, Brichard V, Debruyne C, Therasse P, Altorki N. Efficacy of the MAGE-A3 cancer immunotherapeutic as adjuvant therapy in patients with resected MAGE-A3-positive non-small-cell lung cancer (MAGRIT): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2016 Jun;17(6):822-835. doi: 10.1016/S1470-2045(16)00099-1. Epub 2016 Apr 27.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2014
December 2013   (Final data collection date for primary outcome measure)

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.

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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,   Thailand,   Ukraine,   United Kingdom,   United States
Croatia,   Latvia,   Lithuania,   Portugal,   Slovenia
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Study Director: GSK Clinical Trials GlaxoSmithKline
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP