Status:
COMPLETED
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
Lead Sponsor:
GlaxoSmithKline
Conditions:
Lung Cancer, Non-Small Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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. Based on scientific and medical relevance, the c...
Detailed Description
During the treatment period, safety monitoring continued as initially foreseen. Reporting of post-study adverse events (AEs) and serious AEs (SAEs) continued as per protocol. In the best interest of t...
Eligibility Criteria
Inclusion
- 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-menopausal or if she is of childbearing potential, she must practice adequate contraception for 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
- 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.
Key Trial Info
Start Date :
June 12 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2016
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT01853878
Start Date
June 12 2013
End Date
August 24 2016
Last Update
August 28 2019
Active Locations (39)
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1
GSK Investigational Site
Newark, Delaware, United States, 19713
2
GSK Investigational Site
Springfield, Illinois, United States, 62702
3
GSK Investigational Site
Rochester, Minnesota, United States, 55905
4
GSK Investigational Site
Paterson, New Jersey, United States, 08759