A Study to Demonstrate the Benefit of a New Kind of Anti-cancer Treatment [PReferentially Expressed Antigen of MElanoma (PRAME) Immunotherapy] for Patients With Non-Small Cell Lung Cancer (NSCLC), After Removal of Their Tumor

Last updated: August 23, 2019
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

2

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT01853878
116389
2012-002790-55
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study was to test a potential new kind of anti-cancer treatment, called PRAME immunotherapy in resected patients with lung cancer.

As of 18 July 2014, the recruitment was stopped prematurely and the study was unblinded. Only patients on active treatment will have the option to continue in the study. Patients randomised to the Placebo group were withdrawn.

There will no longer be an active follow-up of patients after discontinuation or completion of the treatment. The study will end 30 days after the last dose will be administered.

As a result, primary and secondary objectives will not be assessed as planned. All clinical and safety data collected in the study will be analysed descriptively. For each biological sample already collected in the scope of this study and not tested yet, testing will not be performed by default, except if a scientific rationale remains relevant despite the premature termination of the study.

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

Total Participants: 137
Study Start date:
June 12, 2013
Estimated Completion Date:
August 24, 2016

Study Description

During the treatment period, safety monitoring will continue as initially foreseen. Reporting of post-study adverse events (AEs) and serious AEs (SAEs) will continue as per protocol. In the best interest of the patient, no more biological samples for protocol research purposes (i.e. serum sampling for humoral immunity, whole blood sampling for pharmacogenetics) will be taken.

Connect with a study center

  • GSK Investigational Site

    Tallinn, 13419
    Estonia

    Site Not Available

  • GSK Investigational Site

    Tartu, 51014
    Estonia

    Site Not Available

  • GSK Investigational Site

    Créteil cedex, 94010
    France

    Site Not Available

  • GSK Investigational Site

    Lyon cedex 08, 69373
    France

    Site Not Available

  • GSK Investigational Site

    Marseille cedex 20, 13915
    France

    Site Not Available

  • GSK Investigational Site

    Montpellier, 34295
    France

    Site Not Available

  • GSK Investigational Site

    Heidelberg, Baden-Wuerttemberg 69126
    Germany

    Site Not Available

  • GSK Investigational Site

    Muenchen, Bayern 81925
    Germany

    Site Not Available

  • GSK Investigational Site

    Immenhausen, Hessen 34376
    Germany

    Site Not Available

  • GSK Investigational Site

    Herne, Nordrhein-Westfalen 44623
    Germany

    Site Not Available

  • GSK Investigational Site

    Koeln, Nordrhein-Westfalen 51109
    Germany

    Site Not Available

  • GSK Investigational Site

    Moers, Nordrhein-Westfalen 47441
    Germany

    Site Not Available

  • GSK Investigational Site

    Muenster, Nordrhein-Westfalen 48153
    Germany

    Site Not Available

  • GSK Investigational Site

    Velbert, Nordrhein-Westfalen 42551
    Germany

    Site Not Available

  • GSK Investigational Site

    Grosshansdorf, Schleswig-Holstein 22927
    Germany

    Site Not Available

  • GSK Investigational Site

    Berlin, 13125
    Germany

    Site Not Available

  • GSK Investigational Site

    Hyogo, 673-8558
    Japan

    Site Not Available

  • GSK Investigational Site

    Kanagawa, 241-8515
    Japan

    Site Not Available

  • GSK Investigational Site

    Shizuoka, 411-8777
    Japan

    Site Not Available

  • GSK Investigational Site

    Seoul, 120-752
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Checiny, 26-060
    Poland

    Site Not Available

  • GSK Investigational Site

    Gdansk, 80-952
    Poland

    Site Not Available

  • GSK Investigational Site

    Szczecin, 70-891
    Poland

    Site Not Available

  • GSK Investigational Site

    Zakopane, 34-500
    Poland

    Site Not Available

  • GSK Investigational Site

    Chelyabinsk, 454087
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    St. Petersburg, 197 089
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Cambridge, Cambridgeshire CB23 3RE
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Edinburgh, Midlothian EH4 2XU
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Birmingham, B9 5SS
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Manchester, M23 9LT
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Sheffield, S10 2SJ
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Newark, Delaware 19713
    United States

    Site Not Available

  • GSK Investigational Site

    Springfield, Illinois 62702
    United States

    Site Not Available

  • GSK Investigational Site

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • GSK Investigational Site

    Manchester, New Jersey 08759
    United States

    Site Not Available

  • GSK Investigational Site

    Flushing, New York 11355
    United States

    Site Not Available

  • GSK Investigational Site

    New York, New York 10021
    United States

    Site Not Available

  • GSK Investigational Site

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • GSK Investigational Site

    Everett, Washington 98201
    United States

    Site Not Available

  • GSK Investigational Site

    Seattle, Washington 98104
    United States

    Site Not Available

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