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This study evaluates the vaccine GSK 249553 in patients with non-small cell lung cancer (NSCLC) whose tumor was removed by surgery. It included patients over 18 with completely resected stage IB-IIB NSCLC. It was a Phase 2 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * 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 findings. 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 antibody test. * (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. Exclusion Criteria: * 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 treatment. * Pregnant/lactating. * (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 cervix). * Concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk. * 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 immunosuppressive agents. * 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.