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临床试验/NCT00290355
NCT00290355已完成2 期

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

GlaxoSmithKline62 个研究点 分布在 12 个国家目标入组 182 人开始时间: 2002年5月28日最近更新:
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适应症

试验速览

阶段
2 期
状态
已完成
入组人数
182
试验地点
62
主要终点
Number of Patients Reporting Confirmed Non-small-cell Lung Cancer (NSCLC) Recurrence
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Patients will receive injections of GSK 249553 vaccine . Appropriate tests will be performed to assess the safety of the treatment and its ability to induce an immune response.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •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:
  • •Removal of all gross disease with negative resection margins, by lobectomy, sleeve resection, bilobectomy or pneumonectomy, based on intra-operative findings.
  • •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.

排除标准

  • •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.

结局指标

主要结局

Number of Patients Reporting Confirmed Non-small-cell Lung Cancer (NSCLC) Recurrence

时间窗: Over a median follow-up time of 28 months post-Dose 1

Types of recurrence included local, regional and distant metastasis and second primary lung tumours, and comprised: Local recurrence, defined as a tumour within the same lung or at the bronchial stump; Regional recurrence, involving a clinically or radiologically manifest disease in the mediastinum or in supraclavicular nodes; and Distant recurrence, i.e., any tumour arising in the contralateral lung or outside the hemithorax. The time to recurrence was defined as the interval from the date of surgical resection to the date of recurrence. The latter was defined as the date of the first study assessment at which new lesion(s) were found and confirmed by appropriate imaging.

次要结局

  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 8-day (Days 0-7) post-vaccination period, across doses)
  • Number of Participants Who Died - Overall Survival (OS)(Over a median follow-up time of 44 months post-Dose 1)
  • Number of Subjects Seropositive Against MAGE-A3(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))
  • Anti- MAGE-A3 Antibody Concentrations(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(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)(Over a median follow-up time of 44 months post-Dose 1)
  • Number of Patients Reporting Non-small-cell Lung Cancer (NSCLC) Recurrence by Gene Signature(Over a median follow up time of 86 months)
  • Percentage of Patients With Disease Recurrence(At 6, 12, 18, 24 and 30 months after enrolment)
  • Anti-protein D (Anti-PD) Antibody Concentrations(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 Any Unsolicited Adverse Events (AEs)(Within the 31-day (Days 0-30) post-vaccination period)
  • Number of Subjects With Serious Adverse Events (SAEs)(Throughout the study (Day 0 - Month 86))
  • Number of Subjects With Normal and Abnormal Urinalysis Parameters(At Month 6, Month 12, Month 18, Month 24 and Month 30)
  • Number of Subjects With Normal and Abnormal Hematological Parameters(At Month 6, Month 12, Month 18, Month 24 and Month 30)
  • Number of Subjects With Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 4+ Response(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 Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 8+ Response(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 Cell-mediated Immunity (CMI) CD4+ or CD8+ Response(At Week 6, Week 12, Month 9, Month 18, Month 24, at Month 30 and at Month 60)
  • Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms(During the 8-day (Days 0-7) post-vaccination period, across doses)
  • Number of Subjects With Normal and Abnormal Biochemical Parameters(At Month 6, Month 12, Month 18, Month 24 and Month 30)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (62)

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