Study Stopped
The study was terminated following assessment of the lack of efficacy of the study product by the Independent Data monitoring Committee for the study.
GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung Cancer
2 other identifiers
interventional
2,278
32 countries
610
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2007
Longer than P75 for phase_3
610 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2007
CompletedFirst Posted
Study publicly available on registry
May 30, 2007
CompletedStudy Start
First participant enrolled
October 4, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 6, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 23, 2014
CompletedResults Posted
Study results publicly available
January 30, 2019
CompletedDecember 22, 2020
November 1, 2020
6.2 years
May 29, 2007
December 5, 2016
November 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the Overall Population
DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional \& distant metastasis \& 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; \& distant recurrence \[any tumor arising in contralateral lung or outside hemithorax\]). Deaths occurring without prior documentation of recurrence were considered as event \& not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. PYAR= n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.
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
DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional \& distant metastasis \& 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; \& distant recurrence \[any tumor arising in contralateral lung or outside hemithorax\]). Deaths occurring without prior documentation of recurrence were considered as event \& not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. PYAR= n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.
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 (30)
Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the CT Population
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
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
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
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
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)
- +25 more secondary outcomes
Study Arms (2)
GSK1572932 Group
EXPERIMENTALPatients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Placebo Group
PLACEBO COMPARATORPatients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Interventions
Intramuscular administration, 13 doses
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (620)
GSK Investigational Site
Birmingham, Alabama, 35294-3300, United States
GSK Investigational Site
Mobile, Alabama, 36604, United States
GSK Investigational Site
Mobile, Alabama, 36608, United States
GSK Investigational Site
Phoenix, Arizona, 85013, United States
GSK Investigational Site
Scottsdale, Arizona, 85258, United States
GSK Investigational Site
Scottsdale, Arizona, 85259, United States
GSK Investigational Site
Tucson, Arizona, 85724, United States
GSK Investigational Site
Fayetteville, Arkansas, 72703, United States
GSK Investigational Site
Fort Smith, Arkansas, 72917, United States
GSK Investigational Site
Jonesboro, Arkansas, 72401, United States
GSK Investigational Site
Bakersfield, California, 93309, United States
GSK Investigational Site
Beverly Hills, California, 90211, United States
GSK Investigational Site
Burbank, California, 91505, United States
GSK Investigational Site
Duarte, California, 91010, United States
GSK Investigational Site
Fresno, California, 93720, United States
GSK Investigational Site
Greenbrae, California, 94904-2007, United States
GSK Investigational Site
La Jolla, California, 92093-0987, United States
GSK Investigational Site
La Jolla, California, 92093, United States
GSK Investigational Site
Los Angeles, California, 90095, United States
GSK Investigational Site
Montebello, California, 90640, United States
GSK Investigational Site
Orange, California, 92868, United States
GSK Investigational Site
Palm Springs, California, 92262, United States
GSK Investigational Site
Palo Alto, California, 94304, United States
GSK Investigational Site
Pleasant Hill, California, 94523, United States
GSK Investigational Site
Rancho Mirage, California, 92270, United States
GSK Investigational Site
Sacramento, California, 95816, United States
GSK Investigational Site
Sacramento, California, 95817, United States
GSK Investigational Site
San Diego, California, 92121, United States
GSK Investigational Site
San Diego, California, 92123, United States
GSK Investigational Site
San Francisco, California, 94107, United States
GSK Investigational Site
Santa Rosa, California, 95403-1757, United States
GSK Investigational Site
Stanford, California, 94305, United States
GSK Investigational Site
Vallejo, California, 94589, United States
GSK Investigational Site
West Hollywood, California, 90048, United States
GSK Investigational Site
Aurora, Colorado, 80045, United States
GSK Investigational Site
Colorado Springs, Colorado, 80907, United States
GSK Investigational Site
Danbury, Connecticut, 06810, United States
GSK Investigational Site
Torrington, Connecticut, 06790, United States
GSK Investigational Site
Waterbury, Connecticut, 06708, United States
GSK Investigational Site
Newark, Delaware, 19713, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20007, United States
GSK Investigational Site
Boca Raton, Florida, 33486, United States
GSK Investigational Site
Boynton Beach, Florida, 33435, United States
GSK Investigational Site
Deerfield Beach, Florida, 33064, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33316, United States
GSK Investigational Site
Hollywood, Florida, 33021, United States
GSK Investigational Site
Jacksonville, Florida, 32209, United States
GSK Investigational Site
Ocala, Florida, 34474, United States
GSK Investigational Site
Orlando, Florida, 32804, United States
GSK Investigational Site
Orlando, Florida, 32806, United States
GSK Investigational Site
Stuart, Florida, 34994, United States
GSK Investigational Site
Tampa, Florida, 33606, United States
GSK Investigational Site
West Palm Beach, Florida, 33401, United States
GSK Investigational Site
Alpharetta, Georgia, 30005, United States
GSK Investigational Site
Athens, Georgia, 30607, United States
GSK Investigational Site
Atlanta, Georgia, 30318, United States
GSK Investigational Site
Atlanta, Georgia, 30322, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Augusta, Georgia, 30901, United States
GSK Investigational Site
Macon, Georgia, 31201, United States
GSK Investigational Site
Marietta, Georgia, 30060, United States
GSK Investigational Site
Savannah, Georgia, 31405, United States
GSK Investigational Site
Honolulu, Hawaii, 96813, United States
GSK Investigational Site
Coeur d'Alene, Idaho, 83814, United States
GSK Investigational Site
Chicago, Illinois, 60611, United States
GSK Investigational Site
Chicago, Illinois, 60612, United States
GSK Investigational Site
Chicago, Illinois, 60637, United States
GSK Investigational Site
Decatur, Illinois, 62526, United States
GSK Investigational Site
Evanston, Illinois, 60201, United States
GSK Investigational Site
Harvey, Illinois, 60426, United States
GSK Investigational Site
Park Ridge, Illinois, 60068, United States
GSK Investigational Site
Peoria, Illinois, 61615-7822, United States
GSK Investigational Site
Springfield, Illinois, 62794-9638, United States
GSK Investigational Site
Evansville, Indiana, 47713, United States
GSK Investigational Site
Indianapolis, Indiana, 46260, United States
GSK Investigational Site
Indianapolis, Indiana, United States
GSK Investigational Site
Munster, Indiana, 46321, United States
GSK Investigational Site
New Albany, Indiana, 47150, United States
GSK Investigational Site
Waterloo, Iowa, 50701, United States
GSK Investigational Site
Ashland, Kentucky, 41101, United States
GSK Investigational Site
Hazard, Kentucky, 41701, United States
GSK Investigational Site
Lexington, Kentucky, 40503, United States
GSK Investigational Site
Louisville, Kentucky, 40245, United States
GSK Investigational Site
Owensboro, Kentucky, 42303, United States
GSK Investigational Site
Alexandria, Louisiana, 71301, United States
GSK Investigational Site
Metairie, Louisiana, 70006, United States
GSK Investigational Site
Shreveport, Louisiana, 71101, United States
GSK Investigational Site
Annapolis, Maryland, 21401, United States
GSK Investigational Site
Baltimore, Maryland, 21201, United States
GSK Investigational Site
Baltimore, Maryland, 21204, United States
GSK Investigational Site
Baltimore, Maryland, 21215, United States
GSK Investigational Site
Baltimore, Maryland, 21237, United States
GSK Investigational Site
Bethesda, Maryland, 20892-1201, United States
GSK Investigational Site
Silver Spring, Maryland, 20902, United States
GSK Investigational Site
Towson, Maryland, 21204, United States
GSK Investigational Site
Boston, Massachusetts, 02111, United States
GSK Investigational Site
Boston, Massachusetts, 02114, United States
GSK Investigational Site
Boston, Massachusetts, 02118, United States
GSK Investigational Site
Worcester, Massachusetts, 01605, United States
GSK Investigational Site
Worcester, Massachusetts, 01608, United States
GSK Investigational Site
Ann Arbor, Michigan, 48109, United States
GSK Investigational Site
Bay City, Michigan, 48706, United States
GSK Investigational Site
Detroit, Michigan, 48201, United States
GSK Investigational Site
Detroit, Michigan, 48202, United States
GSK Investigational Site
Flint, Michigan, 48503, United States
GSK Investigational Site
Grand Rapids, Michigan, 49503, United States
GSK Investigational Site
Lansing, Michigan, 48910, United States
GSK Investigational Site
Lapeer, Michigan, 48446, United States
GSK Investigational Site
Southfield, Michigan, 48075, United States
GSK Investigational Site
Minneapolis, Minnesota, 55407-3799, United States
GSK Investigational Site
Minneapolis, Minnesota, 55455, United States
GSK Investigational Site
Rochester, Minnesota, 55905, United States
GSK Investigational Site
Saint Louis Park, Minnesota, 55416, United States
GSK Investigational Site
Saint Louis Park, Minnesota, 55426, United States
GSK Investigational Site
Kansas City, Missouri, 64111, United States
GSK Investigational Site
Kansas City, Missouri, 64132, United States
GSK Investigational Site
Springfield, Missouri, 65804, United States
GSK Investigational Site
St Louis, Missouri, 63110, United States
GSK Investigational Site
Billings, Montana, 59102, United States
GSK Investigational Site
Grand Island, Nebraska, 68803, United States
GSK Investigational Site
Omaha, Nebraska, 68114, United States
GSK Investigational Site
Henderson, Nevada, 89052, United States
GSK Investigational Site
Lebanon, New Hampshire, 03756, United States
GSK Investigational Site
Long Branch, New Jersey, 07740, United States
GSK Investigational Site
Paramus, New Jersey, 07652, United States
GSK Investigational Site
Armonk, New York, 10504, United States
GSK Investigational Site
Buffalo, New York, 14263, United States
GSK Investigational Site
East Syracuse, New York, 13057, United States
GSK Investigational Site
Flushing, New York, 11355, United States
GSK Investigational Site
Mineola, New York, 11501, United States
GSK Investigational Site
New York, New York, 10003, United States
GSK Investigational Site
New York, New York, 10011, United States
GSK Investigational Site
New York, New York, 10016, United States
GSK Investigational Site
New York, New York, 10019, United States
GSK Investigational Site
New York, New York, 10032, United States
GSK Investigational Site
New York, New York, 10065, United States
GSK Investigational Site
Syracuse, New York, 13210, United States
GSK Investigational Site
Chapel Hill, North Carolina, 27599-7065, United States
GSK Investigational Site
Charlotte, North Carolina, 28203, United States
GSK Investigational Site
Charlotte, North Carolina, 28204, United States
GSK Investigational Site
Durham, North Carolina, 27705, United States
GSK Investigational Site
Durham, North Carolina, 27710, United States
GSK Investigational Site
Greenville, North Carolina, 27834, United States
GSK Investigational Site
Akron, Ohio, 44304, United States
GSK Investigational Site
Canton, Ohio, 44710, United States
GSK Investigational Site
Cincinnati, Ohio, 45242, United States
GSK Investigational Site
Cincinnati, Ohio, 45267, United States
GSK Investigational Site
Columbus, Ohio, 43210, United States
GSK Investigational Site
Dayton, Ohio, 45429, United States
GSK Investigational Site
Tulsa, Oklahoma, 74136, United States
GSK Investigational Site
Bend, Oregon, 97701, United States
GSK Investigational Site
Portland, Oregon, 97213, United States
GSK Investigational Site
Bethlehem, Pennsylvania, 18015, United States
GSK Investigational Site
Danville, Pennsylvania, 17822, United States
GSK Investigational Site
Lancaster, Pennsylvania, 17605, United States
GSK Investigational Site
Langhorne, Pennsylvania, 19047, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19104, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19111, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19140, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15212, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15232, United States
GSK Investigational Site
Sayre, Pennsylvania, 18840, United States
GSK Investigational Site
Wilkes-Barre, Pennsylvania, 18702, United States
GSK Investigational Site
Willow Grove, Pennsylvania, 19090, United States
GSK Investigational Site
Providence, Rhode Island, 02903, United States
GSK Investigational Site
Providence, Rhode Island, 02906, United States
GSK Investigational Site
Charleston, South Carolina, 29414, United States
GSK Investigational Site
Charleston, South Carolina, 29425, United States
GSK Investigational Site
Columbia, South Carolina, 29209, United States
GSK Investigational Site
Greenville, South Carolina, 29615, United States
GSK Investigational Site
Spartanburg, South Carolina, 29303, United States
GSK Investigational Site
Sumter, South Carolina, 29150, United States
GSK Investigational Site
Chattanooga, Tennessee, 37421, United States
GSK Investigational Site
Cookeville, Tennessee, 38501, United States
GSK Investigational Site
Knoxville, Tennessee, 37905, United States
GSK Investigational Site
Knoxville, Tennessee, 37920, United States
GSK Investigational Site
Memphis, Tennessee, 38104, United States
GSK Investigational Site
Memphis, Tennessee, 38120, United States
GSK Investigational Site
Nashville, Tennessee, 37203, United States
GSK Investigational Site
Amarillo, Texas, 79106, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
Dallas, Texas, 75231, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
GSK Investigational Site
Grapevine, Texas, 76051, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Houston, Texas, 77090, United States
GSK Investigational Site
Round Rock, Texas, 78665, United States
GSK Investigational Site
Tyler, Texas, 75708-3154, United States
GSK Investigational Site
Ogden, Utah, 84403, United States
GSK Investigational Site
Salt Lake City, Utah, 84106, United States
GSK Investigational Site
Fairfax, Virginia, 22031, United States
GSK Investigational Site
Roanoke, Virginia, 24014, United States
GSK Investigational Site
Everett, Washington, 98201, United States
GSK Investigational Site
Seattle, Washington, 98104, United States
GSK Investigational Site
Seattle, Washington, 98108, United States
GSK Investigational Site
Seattle, Washington, 98109, United States
GSK Investigational Site
Spokane, Washington, 99208, United States
GSK Investigational Site
Tacoma, Washington, 98405, United States
GSK Investigational Site
Vancouver, Washington, 98664, United States
GSK Investigational Site
Madison, Wisconsin, 53792, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53226, United States
GSK Investigational Site
C.a.b.a., Buenos Aires, C1425EHD, Argentina
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1430CLD, Argentina
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1125ABD, Argentina
GSK Investigational Site
Córdoba, Córdoba Province, X5000JFK, Argentina
GSK Investigational Site
Cipolletti, Río Negro Province, R8324EMB, Argentina
GSK Investigational Site
Rosario, Santa Fe Province, S2000KZE, Argentina
GSK Investigational Site
Quilmes, 1878, Argentina
GSK Investigational Site
San Miguel de Tucumán, 4000, Argentina
GSK Investigational Site
Santa Fe, 3000, Argentina
GSK Investigational Site
Garran, Australian Capital Territory, 2606, Australia
GSK Investigational Site
Camperdown, New South Wales, 2050, Australia
GSK Investigational Site
Tweed Heads, New South Wales, 2485, Australia
GSK Investigational Site
Waratah, New South Wales, 2298, Australia
GSK Investigational Site
Westmead, New South Wales, 2145, Australia
GSK Investigational Site
Chermside, Queensland, 4032, Australia
GSK Investigational Site
South Brisbane, Queensland, 4101, Australia
GSK Investigational Site
Woolloongabba, Queensland, 4102, Australia
GSK Investigational Site
Adelaide, South Australia, 5000, Australia
GSK Investigational Site
Hobart, Tasmania, 7000, Australia
GSK Investigational Site
Box Hill, Victoria, 3128, Australia
GSK Investigational Site
Fitzroy, Victoria, 3065, Australia
GSK Investigational Site
Heidelberg, Victoria, 3084, Australia
GSK Investigational Site
Richmond, Victoria, 3121, Australia
GSK Investigational Site
Nedlands, Western Australia, 6009, Australia
GSK Investigational Site
Perth, Western Australia, 6001, Australia
GSK Investigational Site
Graz, A-8036, Austria
GSK Investigational Site
Innsbruck, 6020, Austria
GSK Investigational Site
Linz, A-4010, Austria
GSK Investigational Site
Linz, A-4020, Austria
GSK Investigational Site
Salzburg, A-5020, Austria
GSK Investigational Site
Vienna, 1130, Austria
GSK Investigational Site
Vienna, A-1090, Austria
GSK Investigational Site
Wels, A-4600, Austria
GSK Investigational Site
Antwerp, 2020, Belgium
GSK Investigational Site
Brussels, 1070, Belgium
GSK Investigational Site
Brussels, 1200, Belgium
GSK Investigational Site
Charleroi, 6000, Belgium
GSK Investigational Site
Duffel, 2570, Belgium
GSK Investigational Site
Edegem, 2650, Belgium
GSK Investigational Site
Genk, 3600, Belgium
GSK Investigational Site
Hasselt, 3500, Belgium
GSK Investigational Site
Jette, 1090, Belgium
GSK Investigational Site
Leuven, 3000, Belgium
GSK Investigational Site
Liège, 4000, Belgium
GSK Investigational Site
Namur, 5000, Belgium
GSK Investigational Site
Belo Horizonte, Minas Gerais, 30730-540, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90610 000, Brazil
GSK Investigational Site
Barretos, São Paulo, 14784-400, Brazil
GSK Investigational Site
Santo André, São Paulo, 09060-650, Brazil
GSK Investigational Site
Rio de Janeiro, 20230-130, Brazil
GSK Investigational Site
São Paulo, 01224-010, Brazil
GSK Investigational Site
São Paulo, 01308-050, Brazil
GSK Investigational Site
São Paulo, 01509-900, Brazil
GSK Investigational Site
Calgary, Alberta, T2N 4N2, Canada
GSK Investigational Site
Edmonton, Alberta, T6G 1Z2, Canada
GSK Investigational Site
Surrey, British Columbia, V3V 1N1, Canada
GSK Investigational Site
Halifax, Nova Scotia, B3J 2Y9, Canada
GSK Investigational Site
Hamilton, Ontario, L8V 5C2, Canada
GSK Investigational Site
London, Ontario, N6A 5W9, Canada
GSK Investigational Site
Newmarket, Ontario, L3Y 2P9, Canada
GSK Investigational Site
Saint Catherines, Ontario, L2S 0A9, Canada
GSK Investigational Site
Scarborough Village, Ontario, M1P 2V5, Canada
GSK Investigational Site
Toronto, Ontario, M4C 3E7, Canada
GSK Investigational Site
Toronto, Ontario, M5G 1X5, Canada
GSK Investigational Site
Toronto, Ontario, M6R 1B5, Canada
GSK Investigational Site
Greenfield Park, Quebec, J4V 2H1, Canada
GSK Investigational Site
Montreal, Quebec, H1T 2M4, Canada
GSK Investigational Site
Montreal, Quebec, H2L 4M1, Canada
GSK Investigational Site
Montreal, Quebec, H3T1E2, Canada
GSK Investigational Site
Montreal, Quebec, H4J 1C5, Canada
GSK Investigational Site
Québec, G1V 4G5, Canada
GSK Investigational Site
Guangzhou, Guangdong, 510060, China
GSK Investigational Site
Guangzhou, Guangdong, 510120, China
GSK Investigational Site
Nanning, Guangxi, 530021, China
GSK Investigational Site
Wuhan, Hubei, 430030, China
GSK Investigational Site
Nanjing, Jiangsu, 210002, China
GSK Investigational Site
Changchun, Jilin, 130012, China
GSK Investigational Site
Chengdu, Sichuan, 610041, China
GSK Investigational Site
Hangzhou, Zhejiang, 310003, China
GSK Investigational Site
Hangzhou, Zhejiang, 310022, China
GSK Investigational Site
Beijing, China
GSK Investigational Site
Changsha, China
GSK Investigational Site
Guangzhou, China
GSK Investigational Site
Harbin, China
GSK Investigational Site
Shanghai, 200030, China
GSK Investigational Site
Shanghai, 200032, China
GSK Investigational Site
Shanghai, 200433, China
GSK Investigational Site
Tianjin, 300052, China
GSK Investigational Site
Wuhan, China
GSK Investigational Site
Brno, 625 00, Czechia
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Ostrava, 708 52, Czechia
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Pilsen, 305 99, Czechia
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Prague, 150 06, Czechia
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Paris, 75970, France
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Related Publications (3)
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.
PMID: 27132212BACKGROUNDDizier B, Callegaro A, Debois M, Dreno B, Hersey P, Gogas HJ, Kirkwood JM, Vansteenkiste JF, Sequist LV, Atanackovic D, Goeman J, van Houwelingen H, Salceda S, Wang F, Therasse P, Debruyne C, Spiessens B, Brichard VG, Louahed J, Ulloa-Montoya F. A Th1/IFNgamma Gene Signature Is Prognostic in the Adjuvant Setting of Resectable High-Risk Melanoma but Not in Non-Small Cell Lung Cancer. Clin Cancer Res. 2020 Apr 1;26(7):1725-1735. doi: 10.1158/1078-0432.CCR-18-3717. Epub 2019 Nov 15.
PMID: 31732522BACKGROUNDZhu J, Yuan Y, Wan X, Yin D, Li R, Chen W, Suo C, Song H. Immunotherapy (excluding checkpoint inhibitors) for stage I to III non-small cell lung cancer treated with surgery or radiotherapy with curative intent. Cochrane Database Syst Rev. 2021 Dec 6;12(12):CD011300. doi: 10.1002/14651858.CD011300.pub3.
PMID: 34870327DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2007
First Posted
May 30, 2007
Study Start
October 4, 2007
Primary Completion
December 6, 2013
Study Completion
September 23, 2014
Last Updated
December 22, 2020
Results First Posted
January 30, 2019
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD is available via the Clinical Study Data Request site (click on the link provided below)
- Access Criteria
- Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD for this study is available via the Clinical Study Data Request site.