CIMAVax EGF in Lung Cancer in PHC. Phase IV
- Conditions
- on-Small Cell advanced Lung Cancer
- Registration Number
- RPCEC00000181
- Lead Sponsor
- Center of Molecular Immunology (CIM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1081
1. Diagnosis NSCLC IIIb / IV in secondary care
2. Either sex, and age equal or greater than 18 years.
3. Eligible No chemotherapy or radiation therapy or who have received the treatment oncospecific available and have no other therapeutic option.
4. Which have signed informed consent for research.
5. Criteria of clinical status ECOG 0-3.
1. Patients who have previously received treatment with EGF therapeutic vaccine CIMAvax and / or Nimotuzumab (therapeutic monoclonal antibody hR3).
2. Patients with chronic or acute infectious diseases, inflammatory or unbalanced
3. Patients with decompensated diabetes.
4. Patients of childbearing potential not using adequate contraception accept (intrauterine devices, barrier methods, or tubal ligation, hormonal methods).
5. Pregnant patients or nursing.
6. Patients with acute allergic conditions or history of severe allergic reactions.
7. Patients who can not attend or receive the proposed I have difficulties in accessing the APS treatment center.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of severe adverse reactions or deaths. Measuring time: at baseline, monthly during 2 years.
- Secondary Outcome Measures
Name Time Method