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



Status:Completed
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:June 2013
End Date:August 2016

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GSK2302032A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung Cancer

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randomised to the Placebo group were withdrawn.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.

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.

Inclusion Criteria:

- The patient has radically resected NSCLC

- The NSCLC is of pathological stage IA-T1b, IB, II or IIIA NSCLC The surgical technique
for resection of the patient's tumor is anatomical, involving at least a segmentectomy
The 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 of
any study-specific procedure.

- The patient is free of disease (no residual tumor, no loco-regional recurrence, no
distant metastasis), as confirmed by a post- thoracic surgery contrast-enhanced
computed tomography (CT scan) of the chest, upper abdomen and by a contrast-enhanced
CT scan or Magnetic Resonance Imaging (MRI) of the brain. Other examinations should be
performed as clinically indicated.

- Eastern Co-operative Oncology Group (ECOG) performance status of 0, 1 or 2 at the time
of randomization

- Adequate bone-marrow reserve, adequate renal, hepatic and adrenal function as assessed
by standard laboratory criteria

- If the patient is female, she must be of non-childbearing potential, i.e. have a
current tubal ligation, hysterectomy, ovariectomy or be post-menopausalor if she is of
childbearing potential, she must practice adequate contraceptionfor 30 days prior to
administration of study product, have a negative pregnancy test and continue such
precautions during all study treatment period and for 2 months after last treatment
administration.

- Patients who the investigator believes can and will comply with the requirements of
this protocol (e.g. return for active follow-up visits).

Exclusion Criteria:

- The patient is diagnosed with a concomitant malignancy and/or has a history of
malignancy within the past five years or has had a malignancy that has been in
complete remission for less than 5 years. Patients with effectively treated non -
melanoma skin cancers or effectively treated carcinoma in situ of the cervix both of
which 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, except
for:

- Administration of adjuvant platinum-based doublet chemotherapy for the treatment
of 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 with
systemic corticosteroids prescribed for chronic treatment (more than 7 consecutive
days).

- The patient needs chronic long term oxygen therapy (LTOT). The patient has medically
uncontrolled congestive heart failure or hypertension, unstable heart disease or
uncontrolled 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 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 a history of allergic disease or reactions likely to be exacerbated by
any component of the study investigational product.

- The patient has received any investigational or non-registered product within the 30
days preceding randomization, or planned use during the study period.

- For female patients: the patient is pregnant or lactating or is planning to become
pregnant.
We found this trial at
9
sites
Manchester, New Jersey 08759
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Manchester, NJ
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Everett, Washington 98201
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from
Everett, WA
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New York, New York 10032
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from
New York, NY
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Newark, Delaware 19713
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from
Newark, DE
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Philadelphia, Pennsylvania 19104
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from
Philadelphia, PA
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Rochester, Minnesota 55905
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from
Rochester, MN
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Seattle, Washington 98109
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from
Seattle, WA
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Springfield, Illinois 62702
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from
Springfield, IL
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Tallinn, 13619
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from
Tallinn,
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