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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer, Non-Small Cell

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Trial Information

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


This Phase IIb study will be conducted at centres in several European countries according to
a multicentre, international, randomised, double-blind design. It will provide information
about the clinical and immunological efficacy and the tolerability of GSK 249553 when this
is administered to patients with stage IB, II NSCLC. The study treatment will be
administered by intramuscular injection; first administration will take place 4-6 weeks
after surgery. The Protocol Posting has been updated in order to comply with the FDA
Amendment Act, Sep 2007.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Number of days from surgical resection to the recurrence of NSCLC (all types of recurrence will be included)

Outcome Time Frame:

At the time of analysis

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

249553/004

NCT ID:

NCT00290355

Start Date:

May 2002

Completion Date:

July 2011

Related Keywords:

  • Lung Cancer, Non-Small Cell
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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