Non-small-cell Lung Cancer (NSCLC) Stage IIIb/IV
Conditions
Keywords
LUNG CANCER, NSCLC, EGF, CANCER VACCINE, IMMUNOTHERAPY
Brief summary
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).
Interventions
BIOLOGICALRecombinant Human rEGF-P64K/Montanide Vaccine
Sponsors
Bioven Sdn. Bhd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival | Two and a half years |
Secondary
| Measure | 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 |
Countries
Malaysia
Outcome results
None listed