Cancer Immunotherapy GSK1572932A as Adjuvant Therapy for Patients With Tumor-antigen-positive Non-Small Cell Lung Cancer

NCT ID: NCT00455572

Last Updated: 2017-05-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-11
• Study Completion Date: 2013-08-08

Brief Summary

The purpose of this clinical trial is to find out how successfully non-small-cell lung cancer patients are able to give an immune response to injections of the immunotherapeutic product GSK1572932A, and to find out more about the safety of this treatment. A course of eight injections will be administered over 21 weeks; including screening for suitability and all tests, the duration of the study for a patient will be 30-35 weeks. During this period various tests will be performed, including physical examinations and blood tests. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed Description

This is an open, four-arm, parallel-group study, to be conducted at approximately 20 centers in Europe and Canada. All patients will receive the same immunotherapeutic treatment with GSK1572932A, but they will be recruited into four cohorts according to the details of their disease. Cohort 1: Patients with resected stage IB, II or IIIA tumors who are due for standard chemotherapy with cisplatin and vinorelbine. These patients will receive chemo-and immunotherapy in parallel. Cohort 2: Patients with resected stage IB, II or IIIA tumors who are due for standard chemotherapy with cisplatin and vinorelbine. These patients will first receive chemotherapy and then immunotherapy.

Cohort 3: Patients with resected stage IB, II or IIIA tumors who are not due for chemotherapy. These patients will receive immunotherapy only. Cohort 4: Patients with unresectable stage III tumors, following standard chemotherapy and/or radiotherapy. These patients will receive immunotherapy only. Immunotherapeutic treatment will comprise eight doses of GSK1572932A. Doses will be administered at three-week intervals; in Cohort 1 this may be adapted to fit in with the patient's chemotherapy. During the study, adjuvant radiotherapy is allowed in Cohorts 1, 2 and 3 for patients in stage III only and is prohibited in Cohort 4. Chemotherapy during the study is allowed in Cohort 1 only as described above, and is prohibited in Cohorts 2-4. The total maximum duration of the study for a patient will be 30-35 weeks.

Conditions

Lung Cancer, Non-Small Cell

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

Patients with resected stage IB, II or IIIA tumors who are due for standard chemotherapy with cisplatin and vinorelbine. These patients will receive chemo-and immunotherapy in parallel.

Group Type: EXPERIMENTAL

Immunotherapeutic GSK1572932A

Intervention Type: BIOLOGICAL

Intramuscular injection, 8 doses

Cisplatin (CDDP)

Intervention Type: DRUG

Four cycles with doses based on patient's body surface area, intravenous administration

Vinorelbine

Intervention Type: DRUG

Four cycles with doses based on patient's body surface area , intravenous administration

Cohort 2

Patients with resected stage IB, II or IIIA tumors who are due for standard chemotherapy with cisplatin and vinorelbine. These patients will first receive chemotherapy and then immunotherapy

Group Type: EXPERIMENTAL

Immunotherapeutic GSK1572932A

Intervention Type: BIOLOGICAL

Intramuscular injection, 8 doses

Cisplatin (CDDP)

Intervention Type: DRUG

Four cycles with doses based on patient's body surface area, intravenous administration

Vinorelbine

Intervention Type: DRUG

Four cycles with doses based on patient's body surface area , intravenous administration

Cohort 3

Patients with resected stage IB, II or IIIA tumors who are not due for chemotherapy. These patients will receive immunotherapy only.

Group Type: EXPERIMENTAL

Immunotherapeutic GSK1572932A

Intervention Type: BIOLOGICAL

Intramuscular injection, 8 doses

Cohort 4

Patients with unresectable stage III tumors, following standard chemotherapy and/or radiotherapy. These patients will receive immunotherapy only.

Group Type: EXPERIMENTAL

Immunotherapeutic GSK1572932A

Intervention Type: BIOLOGICAL

Intramuscular injection, 8 doses

Cisplatin (CDDP)

Intervention Type: DRUG

Four cycles with doses based on patient's body surface area, intravenous administration

Vinorelbine

Intervention Type: DRUG

Four cycles with doses based on patient's body surface area , intravenous administration

Radiotherapy

Intervention Type: PROCEDURE

Regimen will be based upon the site's own standard procedures

Interventions

Immunotherapeutic GSK1572932A

Intramuscular injection, 8 doses

Intervention Type: BIOLOGICAL

Cisplatin (CDDP)

Four cycles with doses based on patient's body surface area, intravenous administration

Intervention Type: DRUG

Vinorelbine

Four cycles with doses based on patient's body surface area , intravenous administration

Intervention Type: DRUG

Radiotherapy

Regimen will be based upon the site's own standard procedures

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Written informed consent obtained,
• Aged 18 or more,
• Pathologically proven stage IB, II or III NSCLC,
• Tumor expresses MAGE-A3,
• Free of distant metastasis,
• For Cohort 1, all of the following:

1. Completely resected stage IB, II or IIIA NSCLC,

2. Anatomical tumor resection, involving at least a lobectomy, and nodal sampling as per center standard

3. ECOG performance status = 0 or 1

4. Due to receive adjuvant chemotherapy as permitted in the protocol

5. Not received, not receiving, and not due to receive adjuvant radiotherapy (except stage III patients)

6. First administration of chemotherapy can be scheduled within 4-12 weeks after surgery

• For Cohort 2, all of the following:

1. Resected stage IB, II or IIIA NSCLC,

2. Anatomical tumor resection, involving at least a lobectomy, and nodal sampling as per center standard

3. ECOG PS = 0 or 1

4. Due to receive, or receiving, adjuvant chemotherapy as permitted in the protocol

5. Not received, not receiving, and not due to receive, adjuvant radiotherapy (except stage III patients)

6. First administration of ASCI treatment can be scheduled within 2-4 weeks after the last administration of chemotherapy

7. Received at least 2 cycles of standard chemotherapy before ASCI treatment is initiated, whereafter no further chemotherapy is planned

• For Cohort 3, all of the following:

1. Resected stage IB, II or IIIA NSCLC

2. Anatomical tumor resection, involving at least a lobectomy, and nodal sampling as per center standard

3. ECOG PS = 0 or 1 or 2

4. Not received, not receiving, and not due to receive, adjuvant chemotherapy

5. Not received, not receiving, and not due to receive, adjuvant radiotherapy (this does not apply to patients in stage III)

6. First administration of ASCI treatment can be scheduled within 4-8 weeks after surgery

• For Cohort 4, all of the following:

1. Unresectable stage III NSCLC

2. ECOG PS = 0 or 1 or 2

3. Due to receive, or receiving, chemo- and radiotherapy according to institution standard

4. Received at least 2 cycles of standard chemotherapy before the initiation of ASCI treatment, whereafter no further chemo-/radiotherapy is planned

5. Stable disease or objective response (confirmed by CT scan) after standard chemo-/radiotherapy

6. Administration of ASCI treatment can be scheduled within 2-6 weeks after the last administration of chemo-/radiotherapy

• Laboratory criteria: adequate bone-marrow reserve, adequate renal function, adequate hepatic function.
• For females: EITHER not of child-bearing potential, OR sexually abstinent, OR negative urine pregnancy test + use of adequate contraceptive precautions from 30 days before first study treatment till 2 months after completion of study treatment course
• In the view of the investigator, the patient can and will comply with the requirements of the protocol

Exclusion Criteria

• Previous or concomitant other malignancies, except if effectively treated and considered by the investigator highly likely to have been cured
• Pregnant or lactating
• History of anaphylaxis or severe allergic reaction
• Concurrent severe medical problems, unrelated to the malignancy, limiting full compliance with the study or exposing the patient to unacceptable risk
• Psychiatric or addictive disorders compromising the ability to give informed consent, or to comply with the trial procedures
• HIV-positive
• Require treatment with systemic corticosteroids, or other immunosuppressive agents
• Need home oxygenation
• Received or plan to receive investigational or non-registered product other than the study medication from 30 days before first dose of study medication and during whole study period
• History of chronic alcohol consumption and/or drug abuse

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Genk, , Belgium

GSK Investigational Site

Leuven, , Belgium

GSK Investigational Site

Liège, , Belgium

GSK Investigational Site

Edmonton, Alberta, Canada

GSK Investigational Site

Greenfield Park, Quebec, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Montpellier, , France

GSK Investigational Site

Pierre-Bénite, , France

GSK Investigational Site

Saint-Herblain, , France

GSK Investigational Site

Strasbourg, , France

GSK Investigational Site

Hemer, North Rhine-Westphalia, Germany

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

GSK Investigational Site

Halle, Saxony-Anhalt, Germany

GSK Investigational Site

Großhansdorf, Schleswig-Holstein, Germany

GSK Investigational Site

Bad Berka, Thuringia, Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Udine, Friuli Venezia Giulia, Italy

GSK Investigational Site

Rome, Lazio, Italy

GSK Investigational Site

Genoa, Liguria, Italy

GSK Investigational Site

Milan, Lombardy, Italy

GSK Investigational Site

Milan, Lombardy, Italy

GSK Investigational Site

Wythenshawe, Greater Manchester, United Kingdom

GSK Investigational Site

Bebington, Wirral, , United Kingdom

GSK Investigational Site

London, , United Kingdom

GSK Investigational Site

Nottingham, , United Kingdom

GSK Investigational Site

Southampton, , United Kingdom

Countries

Belgium; Canada; France; Germany; Italy; United Kingdom

References

Pujol JL, Vansteenkiste JF, De Pas TM, Atanackovic D, Reck M, Thomeer M, Douillard JY, Fasola G, Potter V, Taylor P, Bosquee L, Scheubel R, Jarnjak S, Debois M, de Sousa Alves P, Louahed J, Brichard VG, Lehmann FF. Safety and Immunogenicity of MAGE-A3 Cancer Immunotherapeutic with or without Adjuvant Chemotherapy in Patients with Resected Stage IB to III MAGE-A3-Positive Non-Small-Cell Lung Cancer. J Thorac Oncol. 2015 Oct;10(10):1458-67. doi: 10.1097/JTO.0000000000000653.

Reference Type: DERIVED

PMID: 26309191 (View on PubMed)

Study Documents

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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Other Identifiers

107240

Identifier Type: -

Identifier Source: org_study_id