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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00480025




Registration number
NCT00480025
Ethics application status
Date submitted
29/05/2007
Date registered
30/05/2007
Date last updated
22/12/2020

Titles & IDs
Public title
GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung Cancer
Scientific title
GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resectable MAGE-A3 Positive Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
2007-001283-73
Secondary ID [2] 0 0
109493
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer, Non-Small Cell 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - GSK1572932A Antigen-Specific Cancer Immunotherapeutic
Treatment: Other - Placebo Control

Experimental: GSK1572932 Group - Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.

Placebo comparator: Placebo Group - Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.


Treatment: Other: GSK1572932A Antigen-Specific Cancer Immunotherapeutic
Intramuscular administration, 13 doses

Treatment: Other: Placebo Control
Intramuscular administration, 13 doses
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the Overall Population
Timepoint [1] 0 0
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)
Primary outcome [2] 0 0
Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the No-CT Population
Timepoint [2] 0 0
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 outcome [1] 0 0
Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the CT Population
Timepoint [1] 0 0
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 outcome [2] 0 0
Person Year Rate (PYAR) as Regards Overall-survival (OS) in the Overall Population
Timepoint [2] 0 0
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 outcome [3] 0 0
Person Year Rate (PYAR) as Regards Overall-survival (OS) in the No-CT Population
Timepoint [3] 0 0
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 outcome [4] 0 0
Person Year Rate (PYAR) as Regards Overall-survival (OS) in the CT Population
Timepoint [4] 0 0
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 outcome [5] 0 0
Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the Overall Population
Timepoint [5] 0 0
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 outcome [6] 0 0
Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the No-CT Population
Timepoint [6] 0 0
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 outcome [7] 0 0
Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the CT Population
Timepoint [7] 0 0
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 outcome [8] 0 0
Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the Overall Population
Timepoint [8] 0 0
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)
Secondary outcome [9] 0 0
Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the No-CT Population
Timepoint [9] 0 0
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)
Secondary outcome [10] 0 0
Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the CT Population
Timepoint [10] 0 0
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)
Secondary outcome [11] 0 0
Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the Overall Population
Timepoint [11] 0 0
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 outcome [12] 0 0
Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the No-CT Population
Timepoint [12] 0 0
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 outcome [13] 0 0
Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the CT Population
Timepoint [13] 0 0
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)
Secondary outcome [14] 0 0
Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+)
Timepoint [14] 0 0
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)
Secondary outcome [15] 0 0
Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR)
Timepoint [15] 0 0
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)
Secondary outcome [16] 0 0
Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+)
Timepoint [16] 0 0
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)
Secondary outcome [17] 0 0
Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR)
Timepoint [17] 0 0
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)
Secondary outcome [18] 0 0
Health-related Quality of Life (HQL) Scores
Timepoint [18] 0 0
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
Secondary outcome [19] 0 0
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
Timepoint [19] 0 0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [20] 0 0
Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
Timepoint [20] 0 0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [21] 0 0
Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
Timepoint [21] 0 0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [22] 0 0
Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade
Timepoint [22] 0 0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [23] 0 0
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
Timepoint [23] 0 0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [24] 0 0
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
Timepoint [24] 0 0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [25] 0 0
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
Timepoint [25] 0 0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [26] 0 0
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
Timepoint [26] 0 0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [27] 0 0
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
Timepoint [27] 0 0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [28] 0 0
Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
Timepoint [28] 0 0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [29] 0 0
Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Reported - Up to Data Lock Point (DLP)
Timepoint [29] 0 0
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)
Secondary outcome [30] 0 0
Number of Patients With Serious Adverse Events (SAEs) - Up to Data Lock Point (DLP)
Timepoint [30] 0 0
From screening (SCR) up to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/10/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/09/2014
Sample size
Target
Accrual to date
Final
2278
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Garran
Recruitment hospital [2] 0 0
GSK Investigational Site - Camperdown
Recruitment hospital [3] 0 0
GSK Investigational Site - Tweed Heads
Recruitment hospital [4] 0 0
GSK Investigational Site - Waratah
Recruitment hospital [5] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [6] 0 0
GSK Investigational Site - Chermside
Recruitment hospital [7] 0 0
GSK Investigational Site - South Brisbane
Recruitment hospital [8] 0 0
GSK Investigational Site - Woolloongabba
Recruitment hospital [9] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [10] 0 0
GSK Investigational Site - Hobart
Recruitment hospital [11] 0 0
GSK Investigational Site - Box Hill
Recruitment hospital [12] 0 0
GSK Investigational Site - Fitzroy
Recruitment hospital [13] 0 0
GSK Investigational Site - Heidelberg
Recruitment hospital [14] 0 0
GSK Investigational Site - Richmond
Recruitment hospital [15] 0 0
GSK Investigational Site - Nedlands
Recruitment hospital [16] 0 0
GSK Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
2606 - Garran
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [4] 0 0
2298 - Waratah
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
4032 - Chermside
Recruitment postcode(s) [7] 0 0
4101 - South Brisbane
Recruitment postcode(s) [8] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [9] 0 0
5000 - Adelaide
Recruitment postcode(s) [10] 0 0
7000 - Hobart
Recruitment postcode(s) [11] 0 0
3128 - Box Hill
Recruitment postcode(s) [12] 0 0
3065 - Fitzroy
Recruitment postcode(s) [13] 0 0
3084 - Heidelberg
Recruitment postcode(s) [14] 0 0
3121 - Richmond
Recruitment postcode(s) [15] 0 0
6009 - Nedlands
Recruitment postcode(s) [16] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Delaware
Country [8] 0 0
United States of America
State/province [8] 0 0
District of Columbia
Country [9] 0 0
United States of America
State/province [9] 0 0
Florida
Country [10] 0 0
United States of America
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Georgia
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United States of America
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Hawaii
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United States of America
State/province [12] 0 0
Idaho
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United States of America
State/province [13] 0 0
Illinois
Country [14] 0 0
United States of America
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Indiana
Country [15] 0 0
United States of America
State/province [15] 0 0
Iowa
Country [16] 0 0
United States of America
State/province [16] 0 0
Kentucky
Country [17] 0 0
United States of America
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Louisiana
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United States of America
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Montana
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Nebraska
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Nevada
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New Hampshire
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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Tennessee
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United States of America
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Texas
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Utah
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Virginia
Country [40] 0 0
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Washington
Country [41] 0 0
United States of America
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Córdova
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Argentina
State/province [44] 0 0
Río Negro
Country [45] 0 0
Argentina
State/province [45] 0 0
Santa Fe
Country [46] 0 0
Argentina
State/province [46] 0 0
Quilmes
Country [47] 0 0
Argentina
State/province [47] 0 0
Tucuman
Country [48] 0 0
Austria
State/province [48] 0 0
Graz
Country [49] 0 0
Austria
State/province [49] 0 0
Innsbruck
Country [50] 0 0
Austria
State/province [50] 0 0
Linz
Country [51] 0 0
Austria
State/province [51] 0 0
Salzburg
Country [52] 0 0
Austria
State/province [52] 0 0
Vienna
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Austria
State/province [53] 0 0
Wels
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Belgium
State/province [54] 0 0
Antwerpen
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Belgium
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Brussels
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Belgium
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Bruxelles
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Belgium
State/province [57] 0 0
Charleroi
Country [58] 0 0
Belgium
State/province [58] 0 0
Duffel
Country [59] 0 0
Belgium
State/province [59] 0 0
Edegem
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Belgium
State/province [60] 0 0
Genk
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Belgium
State/province [61] 0 0
Hasselt
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Belgium
State/province [62] 0 0
Jette
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Belgium
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Leuven
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Belgium
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Liège
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Belgium
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Namur
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Brazil
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Minas Gerais
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Brazil
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Rio Grande Do Sul
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Brazil
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São Paulo
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Brazil
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Rio de Janeiro
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Canada
State/province [70] 0 0
Alberta
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Canada
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British Columbia
Country [72] 0 0
Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Canada
State/province [75] 0 0
Québec
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China
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Guangdong
Country [77] 0 0
China
State/province [77] 0 0
Guangxi
Country [78] 0 0
China
State/province [78] 0 0
Hubei
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China
State/province [79] 0 0
Jiangsu
Country [80] 0 0
China
State/province [80] 0 0
Jilin
Country [81] 0 0
China
State/province [81] 0 0
Sichuan
Country [82] 0 0
China
State/province [82] 0 0
Zhejiang
Country [83] 0 0
China
State/province [83] 0 0
Beijing
Country [84] 0 0
China
State/province [84] 0 0
Changsha
Country [85] 0 0
China
State/province [85] 0 0
Guangzhou
Country [86] 0 0
China
State/province [86] 0 0
Harbin
Country [87] 0 0
China
State/province [87] 0 0
Shanghai
Country [88] 0 0
China
State/province [88] 0 0
Tianjin
Country [89] 0 0
China
State/province [89] 0 0
Wuhan
Country [90] 0 0
Czechia
State/province [90] 0 0
Brno
Country [91] 0 0
Czechia
State/province [91] 0 0
Ostrava
Country [92] 0 0
Czechia
State/province [92] 0 0
Plzen
Country [93] 0 0
Czechia
State/province [93] 0 0
Praha 5
Country [94] 0 0
Czechia
State/province [94] 0 0
Praha 8
Country [95] 0 0
Czechia
State/province [95] 0 0
Usti nad Labem
Country [96] 0 0
Estonia
State/province [96] 0 0
Tallinn
Country [97] 0 0
Estonia
State/province [97] 0 0
Tartu
Country [98] 0 0
Finland
State/province [98] 0 0
Helsinki
Country [99] 0 0
Finland
State/province [99] 0 0
Oulu
Country [100] 0 0
Finland
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Tampere
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Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00480025
Trial related presentations / publications
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.
Dizier 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.
Zhu 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.
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00480025