CIMAvax-EGF in different maintenance schemes

Not Applicable

Recruiting

• Conditions: NSCLC; Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Lung Diseases; on small cell lung cancer; Carcinoma, Bronchogenic; Thoracic Neoplasms; Bronchial Neoplasms; Respiratory Tract Neoplasms; Respiratory Tract Diseases

• Registration Number: RPCEC00000368
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-12
• Last Update Posted: 19 August 2024
• Study Completion: 2025-09-20
• Results First Posted: 2025-09-30

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. Patients with a cytological / histological diagnosis of non-small cell lung carcinoma in all stages IIIb and IV, of any sex and age equal to or greater than 18 years, who have completed at least 2 cycles of first-line chemotherapy.
2. Patients who have signed the informed consent for the research.
3. Patients with clinical status criteria (ECOG) from 0 to 2.

Exclusion Criteria

1. Patients of childbearing potential who are not using an adequate method of contraception (intrauterine devices, hormonal contraceptives, barrier methods or tubal ligation). In the case of males (vasectomy, use of condoms) while the treatment lasts.
2. Pregnant, lactating or postpartum patients.
3. Patients with uncontrolled intercurrent illnesses including, but not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes mellitus, arterial hypertension and psychiatric illnesses that imply the incompetence of the subject.
4. Patients with brain metastases.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Titer of antibodies against EGF. Measurement time: before the 1st immunization, and then monthly for 2 years.<br>- Concentration of EGF in serum. Measurement time: before the 1st immunization, and then monthly for 2 years.

Secondary Outcome Measures

Name	Time	Method
- Survival Time (total time that the patient lives since the first immunization): Measurement time: from the date of inclusion to the date of death.