A Phase IIB Study to Assess the Efficacy of GSK 249553 as Adjuvant Therapy Given to MAGE-3-Positive Patients With Non-Small-Cell Lung Cancer in Stage IB (T2/N0) or II (T1/N1 or T2/N1 or T3/N0), Who Have Had Complete Surgical Resection
- Written informed consent has been obtained prior to surgical tumour resection and
prior to the performance of any other protocol-specific procedures.
- At least 18 years of age at the time of resection.
- Pathologically proven, surgically staged squamous or non-squamous IB, IIA or IIB
NSCLC, and complete surgical resection.
- The operative technique for resection of the patient's tumour involves at least a
lobectomy or a sleeve lobectomy, conforming to all of the following criteria:
1. Removal of all gross disease with negative resection margins, by lobectomy,
sleeve resection, bilobectomy or pneumonectomy, based on intra-operative
2. The level of nodal sampling is at least as follows:
Levels 4, 7, 10 in both right upper and right middle lobes Levels 4, 7, 9, 10 in right
lower lobe Levels 5, 6, 7 in left upper lobe Levels 7, 9, 10 in left lower lobe. or at the
maximum defined as systematic radical mediastinal lymphadenectomy: all ipsilateral and
easily accessible lymph-node levels must be removed, independently of the location of the
primary tumour. The level of nodal sampling is as follows: Levels 2, 4, 7, 8, 9, 10 in
right-sided tumours, Levels 5, 6, 7, 8, 9, 10 in left-sided tumours
- Tumour shows expression of MAGE-3 antigen.
- Recovered from surgery for at least 4 weeks and not more than 6 weeks.
- ECOG performance status of ≤ 1 at the time of randomisation.
- Laboratory criteria (all of the following must be fulfilled): adequate bone marrow
reserve, adequate renal function, adequate hepatic function, serum bilirubin within
normal range, negative HIV antibody test, negative HBV antigen test, negative HCV
- (For females): EITHER not of child-bearing potential OR sexually abstinent OR all of
the following: negative urine/serum β-HCG pregnancy test, use of adequate
contraceptive precautions for 30 days before first vaccination. Agree to continue
such precautions for 2 months after completion of the course of vaccination.
- Received any anti-cancer specific treatment including radiotherapy, prior to surgery,
unless the treatment was for previous malignancies allowed by the protocol, i.e.,
basal and localised squamous-cell skin carcinoma that has been successfully treated,
or carcinoma in situ of the cervix (see exclusion criterion no. 10).
- Candidate for post-surgery radiation therapy or any kind of anti-cancer-specific
- (For female patients of child-bearing potential): not agree to practice an effective
method of contraception.
- Uncontrolled bleeding disorder.
- Autoimmune disease.
- History of anaphylaxis or severe allergic reaction.
- Undergone splenectomy or radiation to the spleen.
- Received a major organ allograft.
- Malignancies at other sites (except (i) basal and localised squamous-cell skin
carcinoma that has been successfully treated, and (ii) carcinoma in situ of the
- Concurrent severe medical problems, unrelated to the malignancy, that would
significantly limit full compliance with the study or expose the patient to
- Uncontrolled congestive heart failure or hypertension.
- Unstable heart disease or uncontrolled arrhythmia at the time of enrolment.
- Psychiatric or addictive disorders that may compromise ability to give informed
consent, or to comply with the trial procedures.
- Any evidence of residual tumour after surgery.
- Require concomitant treatment with systemic corticosteroids, or any other
- Received chemotherapy, immunotherapy related to NSCLC.
- Need home oxygenation.
- Received any investigational or non-registered drug or vaccine other than the study
vaccine within the 30 days preceding the first dose of study vaccine, or plans to
receive such a drug during the study period.