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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Tumor Antigen-positive Non-Small Cell Lung Cancer, Lung Cancer, Non-Small Cell

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Trial Information

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


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.


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. 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 4-8 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 2-4 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

- In France only: a patient will be eligible for inclusion in this study if either
affiliated to or beneficiary of a social security category

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The anti-MAGE-A3 seroconversion

Outcome Time Frame:

After the fourth dose of ASCI and at the end of treatment

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:

107240

NCT ID:

NCT00455572

Start Date:

May 2007

Completion Date:

November 2013

Related Keywords:

  • Tumor Antigen-positive Non-Small Cell Lung Cancer
  • Lung Cancer, Non-Small Cell
  • Immunotherapeutic
  • Adjuvant cancer therapy
  • Non-small-cell lung cancer
  • ASCI
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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