A Study to Evaluate a New Anti-Cancer Vaccine for Patients with Non-Small Cell Lung Cancer, Given After Tumor Removal by Surgery
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 10-006829
NCT ID: NCT01159964
Sponsor Protocol Number: 113174
About this study
The purpose of this clinical study is to assess the safety and effectiveness of the immunotherapeutic product GSK 2302032A when given to Non-Small Cell Lung Cancer (NSCLC) patients, after tumor removal by surgery.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- Male or female
- Completely resected (R0 resection), pathologically proven stage IB, II or IIIA NSCLC. Patients are allowed to receive adjuvant platinum-based chemotherapy for the treatment of the current NSCLC between surgery and enrolment
- Written informed consent for PRAME gene expression screening on resected tumor tissue has been obtained from the patient prior to shipment of the sample for expression testing, and written informed consent for the complete study participation has been obtained before the performance of any other protocol specific procedure
- ≥ 18 years of age at the time of signature of the first informed consent form
- Tumor shows expression of the PRAME gene
- Surgical technique for resection of the patient's tumor is anatomical, involving at least a lobectomy or a sleeve lobectomy.
- First ASCI administration will be given, either within 12 weeks after surgery or within 8 weeks after day 1 of last chemotherapy cycle and within 32 weeks after resection
- Is free of metastasis, as confirmed by a negative baseline computer tomogram (CT scan) of the chest and upper abdomen as well as CT scan or magnetic resonance imaging (MRI) of the brain
- Tests performed within 6 weeks for the CT scan of the chest and upper abdomen and within 12 weeks for the brain CT scan or MRI before first ASCI administration
- ECOG performance status of 0, 1 or 2
- Adequate bone-marrow reserve, renal, adrenal and hepatic function as assessed by standard laboratory criteria
- Females of non-childbearing potential
- Defined as current tubal-ligation, hysterectomy, ovariectomy or post-menopause
- Has practiced adequate contraception for 30 days prior to study product administration
- Has a negative pregnancy test on the day of administration
- Has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study product administration series
- In the view of the investigator, the patient can and will comply with the requirements of the protocol
- Primary tumor was removed by segmentectomy or wedge resection
- Received any anti-cancer specific treatment, including radiotherapy, immunotherapy, chemotherapy or neo-adjuvant chemotherapy, except for the treatment of previous malignancies allowed by the protocol
- Requires concomitant treatment (more than 7 consecutive days) with systemic corticosteroids or any other immunosuppressive agents
- Using any investigational or non-registered product (drug or vaccine, except influenza vaccine in the context of H1N1 mass-vaccination) other than the study product within the 30 days preceding the first dose of study product, or planned use during the study period
- Has previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for more than 3 years and highly likely to have been cured
- History of allergic disease or reactions likely to be exacerbated by any component of the study investigational product
- History of confirmed adrenal dysfunction
- Has an autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease
- Has received a major organ allograft
- Known to be Human Immunodeficiency Virus (HIV) -positive
- Has an uncontrolled bleeding disorder
- Has uncontrolled congestive heart failure or uncontrolled hypertension, unstable heart disease (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia at the time of enrollment
- Needs home oxygenation
- Has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the trial procedures
- 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
- Pregnant or lactating
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
K Robert Shen, M.D.
Closed for enrollment
Publications are currently not available