A Phase II study to demonstrate the benefit of a new kind of anti-cancer treatment (PRAME Immunotherapy) for patients with a certain type of lung cancer, after removal of their tumor
- Conditions
- on-Small Cell Lung Cancer (Stage IA-T1b, IB, II or IIIA)MedDRA version: 14.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-002790-55-GB
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 681
•The patient has radically resected (R0) NSCLC
•The NSCLC is of pathological stage IA-T1b, IB, II or IIIA NSCLC according to the American Joint Cancer Committee (AJCC) TNM Cancer Staging Manual (7th Edition) (TNM classification)
•The surgical technique for resection of the patient's tumor is anatomical, involving at least a segmentectomy (wedge-resections are not allowed for inclusion in the study)
•The patient's tumor shows expression of PRAME
Note: Analysis will be performed on formalin-fixed paraffin-embedded (FFPE) tissue samples.
•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.
Note: all procedures conducted as part of the patient’s routine clinical management and done prior to obtaining the informed consent to screening may be used for screening or baseline assessments, provided these procedures were done as specified in the protocol and within the protocol-defined timeframes.
•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.
Note that post-thoracic surgery contrast-enhanced chest and upper abdomen CT scans performed up to 6 weeks before randomization and contrast-enhanced brain CT scan or brain MRI performed up to 12 weeks before randomization do not have to be repeated unless clinically indicated.
In case a post-thoracic surgery contrast-enhanced CT scan of the chest and upper abdomen cannot be performed, this must be replaced by a post-thoracic surgery chest and upper abdomen MRI performed in addition to a post-thoracic surgery CT scan with no-contrast or a Positron emission tomography (PET)-CT scan.
Note that equivocal findings at imaging should be carefully discussed by the investigator with the radiologist to avoid having ineligible patients entered into the study.
•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, and defined as:
1. Aboslute neutrophil count- >= 1.0 x 109/L
2. Platelet count- >= 75x 109/L
3. Serum cortisol- >= Lower Limit of Normal (LLN)
4. Serum Creatinine- <= 1.5 times the Upper Limit of Normal (ULN)
5. Total bilirubin-<= 1.5 times the ULN (Except for patients with Gilbert’s syndrome for whom the limit is <=2 x ULN).
6. Alanine transaminase (ALT)- <= 1.5 times the ULN
7. Aspartate aminotransferase (AST)- <= 1.5 times the ULN
8. Alkaline phosphatase (ALP)- <= 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 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).
Are the trial subjects under 18? no
Number of subj
•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 (Please refer to Exclusion criterion 1).
•The patient has been diagnosed with a pIMD. Patients with vitiligo are not excluded from the study.
Note: In the event of a patient presenting with a condition considered by the investigator as pIMD but not listed in Table 13 inclusion should be discussed with the sponsor prior to randomization.
•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).
Note: The use of prednisone (or equivalent) at <= 0.5 mg/kg/day (absolute maximum 40 mg/day) for more than 7 days or at > 0.5 mg/kg/day but for less than 7 consecutive days is allowed. The use of inhaled corticosteroids or topical steroids is also permitted.
•The patient needs chronic long term oxygen therapy (LTOT), defined as >15hr/day as per the Physicians Consortium for Performance Improvement, American Medical Association (AMA).
•The patient has medically uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease or myocardial infarction) 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method