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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer, Non-Small Cell

Thank you

Trial Information

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


"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"

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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Outcome Time Frame:

At predefined time points

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

109493

NCT ID:

NCT00480025

Start Date:

October 2007

Completion Date:

September 2022

Related Keywords:

  • Lung Cancer, Non-Small Cell
  • ASCI
  • Immunotherapeutic
  • MAGRIT
  • Tumor antigen
  • Non-small-cell lung cancer
  • Adjuvant cancer therapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

GSK Investigational SitePhoenix, Arizona  85013 - 4496
GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteIndianapolis, Indiana  46260
GSK Investigational SiteLexington, Kentucky  40536-0098
GSK Investigational SiteSpringfield, Massachusetts  01107
GSK Investigational SiteDuluth, Minnesota  55805
GSK Investigational SiteSt. Louis, Missouri  63141
GSK Investigational SiteRaleigh, North Carolina  27609
GSK Investigational SiteAkron, Ohio  44304
GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SiteGreen Bay, Wisconsin  54301
GSK Investigational SiteSavannah, Georgia  31405
GSK Investigational SitePark Ridge, Illinois  60068
GSK Investigational SiteBettendorf, Iowa  52722
GSK Investigational SiteBaltimore, Maryland  21201
GSK Investigational SiteRoyal Oak, Michigan  48073
GSK Investigational SiteHooksett, New Hampshire  03106
GSK Investigational SitePittsburgh, Pennsylvania  15213
GSK Investigational SiteColumbia, South Carolina  29210
GSK Investigational SiteGermantown, Tennessee  38138
GSK Investigational SiteSalem, Virginia  24153
GSK Investigational SiteNew York, New York  10021
GSK Investigational SiteBirmingham, Alabama  35209
GSK Investigational SiteAurora, Colorado  80012
GSK Investigational SiteWashington, District of Columbia  20307-5001
GSK Investigational SiteCoeur d'Alene, Idaho  83814
GSK Investigational SiteOmaha, Nebraska  68131
GSK Investigational SiteEdison, New Jersey  08837
GSK Investigational SiteOregon City, Oregon  97045
GSK Investigational SiteCranston, Rhode Island  02920
GSK Investigational SiteSeattle, Washington  98133
GSK Investigational SiteNewark, Delaware  19713