Safety and efficacy of VAXIRA® in advanced NSCLC patients not progressing after first line chemotherapy. Phase III.

Phase 3

• Conditions: ung Cancer; Thoracic Neoplasms; Respiratory Tract Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Lung Diseases; Respiratory Tract Diseases

• Registration Number: RPCEC00000336
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Study Completion: 2024-03-01
• Results First Posted: 2024-06-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

1. Patients who meet the diagnostic criteria.
2. Patients with tumor response (total or partial) or stable disease after the first line of oncospecific treatment.
3. Patients aged 18 or more.
4. Patients who have signed informed consent.
5. Serum EGF concentration <870 pg/mL.
6. Patients with clinical status according to ECOG of 0 to 2.
7. Patients with an interval between the end of the oncospecific treatment and the inclusion in the study not exceeding 2 months and the time between response evaluation and time to inclusion not exceeding 1 month.
8. Patients with a life expectancy of 6 months or more.
9. Patients with organs and bone marrow functioning defined by the following parameters: Hemoglobin = 90 g/L (patients with lower Hb level should be transfused prior to inclusion), Total Leukocyte Count =3.0 x 109/L, Neutrophil Absolute Count = 1.5 x 109/L, Platelet Count =100 x 109/L, Bilirubin: up to the upper normal limit , 14. TGP y GOT/GTP: up to 1.5 times the normal upper limit for each institution, or <5 times the upper normal limit for the institution, if the existence of liver metastases is known. 15. Alkaline phosphatase: Up to 2.5 times the normal upper limit for each institution. 16. Creatinine: within normal limits for each institution or creatinine clearance >50 mL/min/1.73 m2 for patients with creatinine levels above normal values for the institution.

Exclusion Criteria

1. Patients with previous history of use of anti idiotipic vaccine 1E10 and/or Nimotuzumab.
2. Patients carrying uncontrolled acute infectious diseases, chronic diseases, or inflammatory diseases.
3. Patients with fertile age who don’t accept to use proper anticonceptives methods (intrauterine devices, barrier methods or tubal ligation, hormonal methods).
4. Patients who are pregnant or breastfeeding.
5. Patients with acute allergic states or with history of severe allergic reaction.
6. Patients who are not tributary of oncospecific treatment.
7. Patients with brain metastases.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival (Time from randomization until death or date of last news). Measurement time: monthly for 1 year.