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
- 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
- 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.
- 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
- Patients bearing brain metastasis from the primary lung tumor.
- Patients bearing a second primary tumor.
- Patients showing progressive disease after finishing first line chemotherapy.