Last updated: 11/27/2020 08:50:09

GSK1572932A Antigen-Specific Cancer Immunotherapeutic as adjuvant therapy in patients with Non-Small Cell Lung Cancer

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GSK study ID
109493
See study documents
Clinicaltrials.gov ID
NCT00480025
See results summary
EudraCT ID
2007-001283-73
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: GSK1572932A Antigen-Specific Cancer Immunotherapeutic as adjuvant therapy in patients with resectable MAGE-A3 positive Non-Small Cell Lung Cancer
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Person year rate (PYAR) as regards disease-free survival (DFS) in the overall population

Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Person year rate (PYAR) as regards disease-free survival (DFS) in the No-CT population

Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Secondary outcomes:

Person year rate (PYAR) as regards disease-free survival (DFS) in the CT population

Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Person year rate (PYAR) as regards overall-survival (OS) in the overall population

Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Person year rate (PYAR) as regards overall-survival (OS) in the No-CT population

Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Person year rate (PYAR) as regards overall-survival (OS) in the CT population

Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Person year rate (PYAR) as regards lung-cancer specific survival (LCSS) in the Overall population

Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Person year rate (PYAR) as regards lung-cancer specific survival (LCSS) in the No-CT population

Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Person year rate (PYAR) as regards lung-cancer specific survival (LCSS) in the CT population

Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Kaplan-Meier estimate (KME) of 2, 3, 4 and 5-year as regards disease-free survival (DFS) in the overall population

Timeframe: KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment. Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Kaplan-Meier estimate (KME) of 2, 3, 4 and 5-year as regards disease-free survival (DFS) in the No-CT population

Timeframe: KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Kaplan-Meier estimate (KME) of 2, 3, 4 and 5-year as regards disease-free survival (DFS) in the CT population

Timeframe: KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment. Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Person year rate (PYAR) as regards disease-free specific survival (DFSS) in the overall population

Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Person year rate (PYAR) as regards disease-free specific survival (DFSS) in the No-CT population

Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Person year rate (PYAR) as regards disease-free specific survival (DFSS) in the CT population

Timeframe: Period of follow-up was from administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Number of subjects seropositive for anti-Melanoma AntiGEn (MAGE)-A3 antibodies (Anti-MAGE-A3 S+)

Timeframe: Pre-treatment (PRE), at Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (At 12M post W120)

Number of humoral responders as regards anti-Melanoma AntiGEn (MAGE)-A3 antibodies (Anti-MAGE-A3 HR)

Timeframe: At Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)

Number of subjects seropositive for anti-protein D (PD) antibodies (Anti-PD S+)

Timeframe: Pre-treatment (PRE), at Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)

Number of humoral responders as regards anti-protein D (PD) antibodies (Anti-PD HR)

Timeframe: At Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)

Health-related quality of life (HQL) scores

Timeframe: At Week (W) 0 on day of treatment (DoT) (W0 DoT), W0 on day post treatment (DpT) (W0 DpT), W6 DoT, W6 DpT, W12 DoT, W12 DpT, Month (M) 6, M9, M12, M24, 6M post W120, at recurrence, and at 12M post W120

Number of patients with abnormal alanine aminotransferase (ALT) values by maximum grade

Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Number of patients with abnormal alanine aspartate aminotransferase (AST) values by maximum grade

Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Number of patients with abnormal alkaline phosphatase (ALKP) values by maximum grade

Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Number of patients with abnormal bilirubin (BIL) values by maximum grade

Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Number of patients with abnormal creatinine (CREA) values by maximum grade

Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Number of patients with abnormal haemoglobin (HGB) values by maximum grade

Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Number of patients with abnormal leukocytes (LEU) values by maximum grade

Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Number of patients with abnormal lymphocytes (LYM) values by maximum grade

Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Number of patients with abnormal neutrophils (NEU) values by maximum grade

Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Number of patients with abnormal platelets (PLA) values by maximum grade

Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Number of patients with any adverse events (AEs) and with AEs by maximum grade reported – Up to data lock point (DLP)

Timeframe: Within the 31-day follow-up period post treatment administration, up to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Number of patients with serious adverse events (SAEs) – Up to data lock point (DLP)

Timeframe: From screening (SCR) up to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Interventions:
  • Biological/vaccine: GSK1572932A Antigen-Specific Cancer Immunotherapeutic
  • Biological/vaccine: Placebo Control
    • Enrollment:
    2278
    Primary completion date:
    2013-06-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Vansteenkiste JF et al. (2016) 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. 17(6):822-835.
    Dizier B et al. (2019) A T-helper 1/interferon-ϒ gene signature is prognostic in the adjuvant setting of resectable high-risk melanoma but not in non-small cell lung cancer. Clin Cancer Res. pii: clincanres.3717.2018. doi: 10.1158/1078-0432.CCR-18-3717. [Epub ahead of print].
    Medical condition
    Lung Cancer, Non-Small Cell
    Product
    GSK1572932A
    Collaborators
    Not applicable
    Study date(s)
    October 2007 to September 2014
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Male or female patient with completely resected, pathologically proven stage IB, II or IIIA NSCLC.
    Inclusion and exclusion criteria
    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. 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.

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    São Paulo, São Paulo, Brazil, 01224-010
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Rio de Janeiro, Rio De Janeiro, Brazil, 20230-130
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Offenbach, Hessen, Germany, 63069
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wroclaw, Poland, 53-439
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Louisville, Kentucky, United States, 40245
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Savannah, Georgia, United States, 31405
    Status
    Study Complete
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    Showing 1 - 6 of 614 Results

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Other
    Actual primary completion date
    2013-06-12
    Actual study completion date
    2014-23-09

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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