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

Lung Cancer, Non-Small Cell Clinical Trial

Official title:

Cancer Immunotherapeutic GSK1572932A as Adjuvant Therapy for Patients With MAGE-A3-positive Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00455572
• Other study ID #: 107240
• Status: Terminated
• Phase: Phase 1
• First received: April 2, 2007
• Last updated: May 12, 2017
• Start date: May 11, 2007
• Est. completion date: August 8, 2013

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 71
• Est. completion date: August 8, 2013
• Est. primary completion date: August 4, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Biological:
• Immunotherapeutic GSK1572932A
Intramuscular injection, 8 doses

Drug:
• Cisplatin (CDDP)
Four cycles with doses based on patient's body surface area, intravenous administration
• Vinorelbine
Four cycles with doses based on patient's body surface area , intravenous administration

Procedure:
• Radiotherapy
Regimen will be based upon the site's own standard procedures

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Genk
Belgium	GSK Investigational Site	Leuven
Belgium	GSK Investigational Site	Liège
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	Greenfield Park	Quebec
Canada	GSK Investigational Site	Montreal	Quebec
France	GSK Investigational Site	Montpellier
France	GSK Investigational Site	Pierre Benite
France	GSK Investigational Site	Saint Herblain
France	GSK Investigational Site	Strasbourg
Germany	GSK Investigational Site	Bad Berka	Thueringen
Germany	GSK Investigational Site	Grosshansdorf	Schleswig-Holstein
Germany	GSK Investigational Site	Halle	Sachsen-Anhalt
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hemer	Nordrhein-Westfalen
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Italy	GSK Investigational Site	Genova	Liguria
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Udine	Friuli-Venezia-Giulia
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	GSK Investigational Site	Wythenshawe	Greater Manchester

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Belgium,  Canada,  France,  Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The anti-MAGE-A3 seroconversion		After the fourth dose of ASCI and at the end of treatment
Primary	The anti-protein D seroconversion		After the fourth dose of ASCI and at the end of treatment
Primary	The anti-CpG seroconversion		After the fourth dose of ASCI and at the end of treatment
Primary	The MAGE-A3 cellular (T cell) response		After the fourth dose of ASCI and at the end of treatment
Primary	Occurrence of adverse events, including abnormal hematological and biochemical laboratory values		During the study
Primary	Occurrence of serious adverse events		During the study

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study 107240 can be found on the GSK Clinical Study Register