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).
Full Title of Study: “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”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Biological: Recombinant Human rEGF-P64K/Montanide Vaccine
Arms, Groups and Cohorts
- Experimental: Vaccine Group
- 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.
- No Intervention: Control Group
- Patients in this arm will only receive Best Supportive Care.
Clinical Trial Outcome Measures
- Time Frame: Two and a half years
- Assessment of immunogenecity, safety as well as preliminary assessment of objective response, time of progression and quality of life
- Time Frame: Two and a half years
Participating in This Clinical Trial
- 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.
- 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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Bioven Sdn. Bhd.
- Provider of Information About this Clinical Study
- DR G SELVARATNAM, NILAI CANCER INSTITUTE
- Overall Official(s)
- G SELVARATNAM, MD, Principal Investigator, NILAI CANCER INSTITUTE
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