Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer (NSCLC) Stages IIIB/IV

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the recombinant human EGF-rP64K/Montanide ISA 51 vaccine is safe, immunogenic and effective in the treatment of stage IIIb/IV non-small-cell lung cancer (NSCLC).

Official Title
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A Phase II/III Trial to Assess the Safety, Immunogenicity and Preliminary Efficacy of Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine Administered to Patients With Non-Small-Cell Lung Cancer (NSCLC) After Receiving Conventional First Line Chemotherapy

Conditions
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Non-small-cell Lung Cancer (NSCLC) Stage IIIb/IV

Intervention / Treatment
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* Biological: Recombinant Human rEGF-P64K/Montanide Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have signed the informed consent form. Patients who are eighteen years of age or over with histologically or cytologically confirmed NSCLC in advanced stages IIIb or IV, not amenable to any attempt of curative chemo-radiotherapy and/or surgery. Patients with measurable lesions, defined as those measurable at least in one dimension (refered to higher diameter) and with a diameter equal or higher 20 mm using conventional techniques (PET, CT scan, MRI, Rx) or equal or higher 10 mm using CT scan. Patients who have finished their last cycle of chemotherapy and/or radiotherapy not less than 4 weeks prior to randomization and not more than 8 weeks. Female patients of reproductive potential must have negative pregnancy tests. Those female volunteers admitted to the study must be using a reliable means of contraception such as tubal ligation, oral contraceptive or IUD. ECOG status 0 to 2. Patients with normal organ and bone marrow function, as defined by the parameters in accordance to that provided by the normal lab reference range. Patients with no evidence of objective disease progression, 1 month after finishing first line chemotherapy as per RECIST. Exclusion Criteria: Patients who are candidates for combined modality treatment. Patients who are receiving immunosuppressive therapy including corticosteroids. Patients who have received immunotherapy within the previous 3 months. Patients who have participated in a clinical study within the previous 30 days. Patients who may be allergic to any component of the vaccine. Medical reasons considered by the investigators as disqualification from the study such as significant uncontrolled co-morbid disease or potential non-compliance with the protocol. Patients bearing brain metastasis from the primary lung tumor. Patients bearing a second primary tumor. Patients showing progressive disease after finishing first line chemotherapy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaccine Group<br>Patients in this arm will receive a low dose of Cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51 vaccine in addition to Best Supportive Care. | Biological: Recombinant Human rEGF-P64K/Montanide Vaccine<br> <br> |
| No Intervention: Control Group<br>Patients in this arm will only receive Best Supportive Care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | Two and a half years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of immunogenecity, safety as well as preliminary assessment of objective response, time of progression and quality of life |  | Two and a half years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LUNG CANCER, NSCLC, EGF, CANCER VACCINE, IMMUNOTHERAPY