Phase
Condition
N/ATreatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The patient has radically resected NSCLC
The NSCLC is of pathological stage IA-T1b, IB, II or IIIA NSCLC The surgical techniquefor resection of the patient's tumor is anatomical, involving at least a segmentectomyThe patient's tumor shows expression of PRAME.
The patient is ≥ 18 years of age at the time of first consent.
Written informed consent has been obtained from the patient prior to performance ofany study-specific procedure.
The patient is free of disease (no residual tumor, no loco-regional recurrence, nodistant metastasis), as confirmed by a post- thoracic surgery contrast-enhancedcomputed tomography (CT scan) of the chest, upper abdomen and by a contrast-enhancedCT scan or Magnetic Resonance Imaging (MRI) of the brain. Other examinations should beperformed as clinically indicated.
Eastern Co-operative Oncology Group (ECOG) performance status of 0, 1 or 2 at the timeof randomization
Adequate bone-marrow reserve, adequate renal, hepatic and adrenal function as assessedby standard laboratory criteria
If the patient is female, she must be of non-childbearing potential, i.e. have acurrent tubal ligation, hysterectomy, ovariectomy or be post-menopausalor if she is ofchildbearing potential, she must practice adequate contraceptionfor 30 days prior toadministration of study product, have a negative pregnancy test and continue suchprecautions during all study treatment period and for 2 months after last treatmentadministration.
Patients who the investigator believes can and will comply with the requirements ofthis protocol (e.g. return for active follow-up visits).
Exclusion
Exclusion Criteria:
The patient is diagnosed with a concomitant malignancy and/or has a history ofmalignancy within the past five years or has had a malignancy that has been incomplete remission for less than 5 years. Patients with effectively treated non -melanoma skin cancers or effectively treated carcinoma in situ of the cervix both ofwhich in remission for less than 5 years will be eligible.
The patient has received any anti-cancer specific treatment, including radiotherapy,immunotherapy, hormonal therapy, chemotherapy or neo-adjuvant chemotherapy, exceptfor:
Administration of adjuvant platinum-based doublet chemotherapy for the treatmentof the current NSCLC allowed between surgery and randomization.
Treatment of previous malignancies as allowed by the protocol.
The patient has been diagnosed with a Potential Immune-Mediated Disease (pIMD).Patients with vitiligo are not excluded from the study.
The patient has a history of confirmed adrenal dysfunction.
The patient requires concomitant treatment with any immunosuppressive agent, or withsystemic corticosteroids prescribed for chronic treatment (more than 7 consecutivedays).
The patient needs chronic long term oxygen therapy (LTOT). The patient has medicallyuncontrolled congestive heart failure or hypertension, unstable heart disease oruncontrolled arrhythmia at the time of randomization.
The patient has an uncontrolled bleeding disorder.
The patient has undergone splenectomy.
The patient is known to be Human Immunodeficiency Virus (HIV)-positive.
The patient has psychiatric or addictive disorders that may compromise his/her abilityto 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 tounacceptable risk.
The patient has a history of allergic disease or reactions likely to be exacerbated byany component of the study investigational product.
The patient has received any investigational or non-registered product within the 30days preceding randomization, or planned use during the study period.
For female patients: the patient is pregnant or lactating or is planning to becomepregnant.
Study Design
Study Description
Connect with a study center
GSK Investigational Site
Tallinn, 13419
EstoniaSite Not Available
GSK Investigational Site
Tartu, 51014
EstoniaSite Not Available
GSK Investigational Site
Créteil cedex, 94010
FranceSite Not Available
GSK Investigational Site
Lyon cedex 08, 69373
FranceSite Not Available
GSK Investigational Site
Marseille cedex 20, 13915
FranceSite Not Available
GSK Investigational Site
Montpellier, 34295
FranceSite Not Available
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg 69126
GermanySite Not Available
GSK Investigational Site
Muenchen, Bayern 81925
GermanySite Not Available
GSK Investigational Site
Immenhausen, Hessen 34376
GermanySite Not Available
GSK Investigational Site
Herne, Nordrhein-Westfalen 44623
GermanySite Not Available
GSK Investigational Site
Koeln, Nordrhein-Westfalen 51109
GermanySite Not Available
GSK Investigational Site
Moers, Nordrhein-Westfalen 47441
GermanySite Not Available
GSK Investigational Site
Muenster, Nordrhein-Westfalen 48153
GermanySite Not Available
GSK Investigational Site
Velbert, Nordrhein-Westfalen 42551
GermanySite Not Available
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein 22927
GermanySite Not Available
GSK Investigational Site
Berlin, 13125
GermanySite Not Available
GSK Investigational Site
Hyogo, 673-8558
JapanSite Not Available
GSK Investigational Site
Kanagawa, 241-8515
JapanSite Not Available
GSK Investigational Site
Shizuoka, 411-8777
JapanSite Not Available
GSK Investigational Site
Seoul, 120-752
Korea, Republic ofSite Not Available
GSK Investigational Site
Checiny, 26-060
PolandSite Not Available
GSK Investigational Site
Gdansk, 80-952
PolandSite Not Available
GSK Investigational Site
Szczecin, 70-891
PolandSite Not Available
GSK Investigational Site
Zakopane, 34-500
PolandSite Not Available
GSK Investigational Site
Chelyabinsk, 454087
Russian FederationSite Not Available
GSK Investigational Site
St. Petersburg, 197 089
Russian FederationSite Not Available
GSK Investigational Site
Cambridge, Cambridgeshire CB23 3RE
United KingdomSite Not Available
GSK Investigational Site
Edinburgh, Midlothian EH4 2XU
United KingdomSite Not Available
GSK Investigational Site
Birmingham, B9 5SS
United KingdomSite Not Available
GSK Investigational Site
Manchester, M23 9LT
United KingdomSite Not Available
GSK Investigational Site
Sheffield, S10 2SJ
United KingdomSite Not Available
GSK Investigational Site
Newark, Delaware 19713
United StatesSite Not Available
GSK Investigational Site
Springfield, Illinois 62702
United StatesSite Not Available
GSK Investigational Site
Rochester, Minnesota 55905
United StatesSite Not Available
GSK Investigational Site
Manchester, New Jersey 08759
United StatesSite Not Available
GSK Investigational Site
Flushing, New York 11355
United StatesSite Not Available
GSK Investigational Site
New York, New York 10021
United StatesSite Not Available
GSK Investigational Site
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
GSK Investigational Site
Everett, Washington 98201
United StatesSite Not Available
GSK Investigational Site
Seattle, Washington 98104
United StatesSite Not Available

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