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



Status:Terminated
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/1/2019
Start Date:October 4, 2007
End Date:September 23, 2014

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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.


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.
We found this trial at
161
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Orange, California 92868
21
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Akron, Ohio 44313
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Alexandria, Louisiana 71301
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Alpharetta, Georgia 30022
1920
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Amarillo, Texas 79106
918
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Ann Arbor, Michigan 48109
1934
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Annapolis, Maryland 21401
2309
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Armonk, New York 10504
2446
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Ashland, Kentucky 41101
1981
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Athens, Georgia 30606
1973
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Atlanta, Georgia 30341
1922
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Augusta, Georgia 30909
2053
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Aurora, Colorado 80010
824
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Bakersfield, California 93309
106
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Baltimore, Maryland 21201
2301
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Bay City, Michigan 48706
1934
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Bend, Oregon 97701
712
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Bethesda, Maryland 20892
2277
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Bethlehem, Pennsylvania 18105
2356
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Beverly Hills, California 90211
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Billings, Montana 59102
949
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Birmingham, Alabama 35249
1777
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Boca Raton, Florida 33486
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Boston, Massachusetts 02115
2578
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Boynton Beach, Florida 33472
2301
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Buffalo, New York 14263
2181
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Burbank, California 91505
19
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C.a.b.a., Buenos Aires
6113
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Canton, Ohio 44708
2043
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Chapel Hill, North Carolina 27599
2194
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Charleston, South Carolina 29425
2184
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Charlotte, North Carolina 28203
2100
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Chattanooga, Tennessee 37421
1862
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Chicago, Illinois 60611
1730
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Cincinnati, Ohio 45229
1880
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Coeur d'Alene, Idaho 83814
942
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Colorado Springs, Colorado 80910
804
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Columbia, South Carolina 29203
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Columbus, Ohio 43219
1965
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1834
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Danbury, Connecticut 06810
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Danville, Pennsylvania 17822
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Dayton, Ohio 45420
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Decatur, Illinois 62526
1645
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Deerfield Beach, Florida 33441
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Detroit, Michigan 48202
1965
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Duarte, California 91010
5
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Durham, North Carolina 27705
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East Syracuse, New York 13057
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Everett, Washington 98201
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Flint, Michigan 48504
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Flushing, New York 11355
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Fort Lauderdale, Florida 33308
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Fresno, California 93720
216
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Grand Island, Nebraska 68803
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Grand Rapids, Michigan 49546
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Grapevine, Texas 76051
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Greenbrae, California 94904
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Greenville, North Carolina 27858
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Greenville, South Carolina 29615
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Harvey, Illinois 60426
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Hazard, Kentucky 41701
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Henderson, Nevada 89052
213
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Hollywood, Florida 33021
2315
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Honolulu, Hawaii 96813
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Indianapolis, Indiana 46202
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Jacksonville, Florida 32207
2131
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Jonesboro, Arkansas 72401
1546
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Kansas City, Missouri 64128
1343
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Knoxville, Tennessee 37916
1923
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La Jolla, California 92093
93
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Lancaster, Pennsylvania 17605
2317
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Langhorne, Pennsylvania 19047
2387
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Lansing, Michigan 48917
1889
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Lapeer, Michigan 48446
1958
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Lebanon, New Hampshire 03756
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Lexington, Kentucky 40504
1879
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Long Branch, New Jersey 07740
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Los Angeles, California 90025
24
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Louisville, Kentucky 40202
1813
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Macon, Georgia 31201
1974
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Madison, Wisconsin 53792
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Marietta, Georgia 30060
1908
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Memphis, Tennessee 38120
1597
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Metairie, Louisiana 70006
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Milwaukee, Wisconsin 53215
1726
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Mineola, New York 11501
2451
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Minneapolis, Minnesota 55404
1509
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Mobile, Alabama 36617
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Montebello, California 90640
6
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Munster, Indiana 46321
1732
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1809
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2435
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