Study to Test the Efficacy of the Vaccine GSK 249553 in Treating Non-small-cell Lung Cancer After Tumour Removal by Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00290355
• Date of registration: 10/02/2006
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline
• Public title: Study to Test the Efficacy of the Vaccine GSK 249553 in Treating Non-small-cell Lung Cancer After Tumour Removal by Surgery
• Scientific title: 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
• Date of first enrolment: May 28, 2002
• Target sample size: 182
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00290355
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Belgium, Estonia, Finland, France, Germany, Greece, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Spain, United Kingdom

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

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 ß-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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Lung Cancer, Non-Small Cell

Intervention(s)

Biological: Placebo

Biological: GSK 249553 vaccine

Primary Outcome(s)

Number of Patients Reporting Confirmed Non-small-cell Lung Cancer (NSCLC) Recurrence [Time Frame: Over a median follow-up time of 28 months post-Dose 1]

Secondary Outcome(s)

Anti- MAGE-A3 Antibody Concentrations [Time Frame: At Day 0, Week 6, Week 12, Month 9, Month 18, Month 24, at Month 30 and at Follow-Up (FU) visit (Post Dose 13 at Month 42 for patients with full treatment course or Post last product dose + 12 months for the other patients)]

Number of Participants Who Died - Overall Survival (OS) [Time Frame: Over a median follow-up time of 44 months post-Dose 1]

Number of Subjects With Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 8+ Response [Time Frame: At Week 6, Week 12, Month 9, Month 18, Month 24, at Month 30 and at Follow-Up (FU) visit (Post Dose 13 at Month 42 for patients with full treatment course or Post last product dose + 12 months for the other patients)]

Number of Subjects With Any and Grade 3 Solicited Local Symptoms [Time Frame: During the 8-day (Days 0-7) post-vaccination period, across doses]

Number of Subjects With Normal and Abnormal Biochemical Parameters [Time Frame: At Month 6, Month 12, Month 18, Month 24 and Month 30]

Number of Patients Reporting Non-small-cell Lung Cancer (NSCLC) Recurrence by Gene Signature [Time Frame: Over a median follow up time of 86 months]

Number of Subjects With Any Unsolicited Adverse Events (AEs) [Time Frame: Within the 31-day (Days 0-30) post-vaccination period]

Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms [Time Frame: During the 8-day (Days 0-7) post-vaccination period, across doses]

Number of Subjects With Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 4+ Response [Time Frame: At Week 6, Week 12, Month 9, Month 18, Month 24, at Month 30 and at Follow-Up (FU) visit (Post Dose 13 at Month 42 for patients with full treatment course or Post last product dose + 12 months for the other patients)]

Anti-protein D (Anti-PD) Antibody Concentrations [Time Frame: At Day 0, Week 6, Week 12, Month 9, Month 18, Month 24, at Month 30 and at Follow-Up (FU) visit (Post Dose 13 at Month 42 for patients with full treatment course or Post last product dose + 12 months for the other patients)]

Number of Patients Reporting Confirmed Non-small-cell Lung Cancer (NSCLC) Recurrence or Death - Disease Free Survival (DFS) [Time Frame: Over a median follow-up time of 44 months post-Dose 1]

Number of Subjects Seropositive Against MAGE-A3 [Time Frame: At Day 0, Week 6, Week 12, Month 9, Month 18, Month 24, at Month 30 and at Follow-Up (FU) visit (Post Dose 13 at Month 42 for patients with full treatment course or Post last product dose + 12 months for the other patients)]

Number of Subjects Seropositive Against Protein D (PD) Antigens [Time Frame: At Day 0, Week 6, Week 12, Month 9, Month 18, Month 24, at Month 30 and at Follow-Up (FU) visit (Post Dose 13 at Month 42 for patients with full treatment course or Post last product dose + 12 months for the other patients)]

Number of Subjects With Cell-mediated Immunity (CMI) CD4+ or CD8+ Response [Time Frame: At Week 6, Week 12, Month 9, Month 18, Month 24, at Month 30 and at Month 60]

Number of Subjects With Serious Adverse Events (SAEs) [Time Frame: Throughout the study (Day 0 - Month 86)]

Number of Subjects With Normal and Abnormal Hematological Parameters [Time Frame: At Month 6, Month 12, Month 18, Month 24 and Month 30]

Number of Subjects With Normal and Abnormal Urinalysis Parameters [Time Frame: At Month 6, Month 12, Month 18, Month 24 and Month 30]

Percentage of Patients With Disease Recurrence [Time Frame: At 6, 12, 18, 24 and 30 months after enrolment]

Secondary ID(s)

249553/004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 25/02/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00290355