Non-small-cell Lung Cancer (NSCLC) Stage IIIb/IV Clinical Trial
— NSCLCOfficial title:
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
| Verified date | September 2011 |
| Source | Bioven Sdn. Bhd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Malaysia: Ministry of Health |
| Study type | Interventional |
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).
| Status | Terminated |
| Enrollment | 230 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Malaysia | Local Institution | Georgetown | Pulau Pinang |
| Malaysia | Local Institution | Klang | Selangor |
| Malaysia | Local Institution | Kota Kinabalu | Sabah |
| Malaysia | Local Institution | Kota Kinabalu | Sabah |
| Malaysia | Local Institution | Kuala Lumpur | |
| Malaysia | Local Institution | Kuala Lumpur | |
| Malaysia | Local Institution | Kuantan | Pahang |
| Malaysia | Local Institution | Kubang Kerian | Kelantan |
| Malaysia | Local Institution | Nilai | Negeri Sembilan |
| Malaysia | Local Institution | Petaling Jaya | Selangor |
| Lead Sponsor | Collaborator |
|---|---|
| Bioven Sdn. Bhd. |
Malaysia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Survival | Two and a half years | No | |
| Secondary | Assessment of immunogenecity, safety as well as preliminary assessment of objective response, time of progression and quality of life | Two and a half years | No |