GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resectable MAGE-A3 Positive Non-Small Cell Lung Cancer
- Male or female patient with completely resected, pathologically proven stage IB, II
or IIIA NSCLC.
- Written informed consent for MAGE-A3 expression screening on tumor biopsy has been
obtained from the patient prior to shipment of the sample for expression testing
(before or just after surgical resection), and written informed consent for the
complete study has been obtained prior to the performance of any other
- Patient is ≥ 18 years of age at the time of signature of the first informed consent
- The patient's tumor shows expression of MAGE-A3 gene
- The surgical technique for resection of the patient's tumor is anatomical, involving
at least a lobectomy or a sleeve lobectomy;
- The mediastinal lymph node sampling is done according to study protocol guidelines;
- The patient is free of metastasis, as confirmed by a negative baseline computer
tomogram (CT scan) of the chest, upper abdomen and CT scan or MRI of the brain.
Other examinations should be performed as clinically indicated. Note that if randomization
is taking place within 8 weeks after surgery, brain CT scans or brain MRI performed up to
4 weeks before surgery do not have to be repeated.
- ECOG performance status of 0, 1 or 2 at the time of randomization.
- Adequate bone-marrow reserve, adequate renal function and adequate hepatic function
as assessed by standard laboratory criteria, and defined as:
Absolute neutrophil count ≥ 1.0 x 10E9/L Platelet count ≥ 75 x 10E9/L Serum creatinine ≤
1.5 times the Upper Limit of Normal (ULN)
≤ 3.0 times the ULN if due to platinum adjuvant chemotherapy Total bilirubin ≤ 1.5 times
the ULN Alanine transaminase (ALAT) ≤ 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 treatment, have a negative pregnancy test and continue
such precautions during all study treatment period and for 2 months after completion
of the injection series.
- In the view of the investigator, the patient can and will comply with the
requirements of the protocol.
- The primary tumor was removed by segmentectomy or wedge resection.
- The patient shows any evidence of residual tumor after surgery.
- The patient has received any anti-cancer specific treatment, including radiotherapy,
immunotherapy, chemotherapy or neo-adjuvant chemotherapy, except:
For the treatment of previous malignancies as allowed by the protocol (i.e., non-melanoma
skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has
been in remission for over 5 years), Administration of adjuvant platinum-based
chemotherapy for the treatment of the current NSCLC is allowed between surgery and
- The patient 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 over 5 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.
- The patient has an autoimmune disease such as, but not limited to, multiple
sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not
- The patient requires concomitant treatment with systemic corticosteroids, or any
other immunosuppressive agents.
Note: The use of prednisone, or equivalent, <0.5 mg/kg/day (absolute maximum 40 mg/day),
or inhaled corticosteroids for COPD or topical steroids is permitted.
- The patient has received a major organ allograft.
- The patient is known to be HIV-positive.
- The patient has an uncontrolled bleeding disorder.
- The patient has uncontrolled congestive heart failure or hypertension, unstable heart
disease (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia
at the time of enrolment.
- The patient needs home oxygenation.
- 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 received any investigational or non-registered medicinal product
other than the study medication within the 30 days preceding the first dose of study
medication, or plans to receive such a drug during the study period.
- For female patients: the patient is pregnant or lactating.