Vaxira as adjuvant treatment for non-small cell lung cancer

Phase 2

• Conditions: on-Small Cell Lung Cancer (NSCLC); Carcinoma, Non-Small-Cell Lung; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

• Registration Number: RPCEC00000207
• Lead Sponsor: ational Institute of Oncology and Radiobiology (INOR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1-Male and female patients = 18 years with tumors in non-small cell lung and pathologically proven completely resected stage IB, II or IIIA stages.
2-Patients who have signed informed consent for research.
3-Patients where surgical technique for tumor resection patient has been anatomical, involving at least a lobectomy .
4-Patients in the mediastinal lymph node sampling has been carried out by radical mediastinal lymphadenectomy corresponding compartment.
5-Disease-free patients (locoregional metastases or relapse), confirmed by a negative CT study at baseline chest CT scan, upper abdomen and brain CT or MRI.
6-Patients with performance status 0-2 according to ECOG scale.
7-Patients who received adjuvant chemotherapy after surgery, have been completed or not all cycles.
8-Patients who have then received adjuvant chemotherapy, radiotherapy treatment option in accordance with pN.
9-Patients in the time between the end of oncospecific treatment and inclusion in the study does not exceed 2 months.
10-Patients with hepatic, renal and haematological normal functions defined by:
-Hemoglobina >= 10 g / L
Leukocyte - Total count >= 3.0 x 109 / L
Absolute Neutrophil -Count >= 1.5 x 109 / L
Platelet -Count >=100 x 109 / L
-Bilirubin To the upper limit of normal.
-TGP And TGO: up 1.5 times the upper limit of normal value of the institution, or <5 times the upper limit of normal value of the institution, if known the existence of liver metastases.
-Fosfatasa Alkaline =< 2.5 times the ULN.
-Creatinina: Within normal limits or creatinine clearance> 50 mL / min / 1.73 m2 for patients with creatinine levels above the normal value of the institution.

Exclusion Criteria

1- Stage IIIA patients who received neoadjuvant chemotherapy before surgery.
2- Patients whose primary tumor was removed by segmentectomy or wedge resection.
3- Patients showing any microscopic evidence of residual tumor after surgery (positive BSQ).
4- Patients who have previously received treatment with VAXIRA® vaccine or other immunotherapy.
5- Patients with previous history of cancer, except nonmelanoma skin tumors or carcinoma in situ of the cervix treated properly.
6- Patients with acute infectious diseases, chronic inflammatory or unbalanced.
7- Patients of childbearing age who do not accept use appropriate contraception (intrauterine devices, barrier methods or tubal ligation, hormonal methods).
8- Patients pregnant or breastfeeding.
9- Patients with acute allergic conditions or history of severe allergic reactions.
10- Patients who have received organ grafts.
11- Patients with psychiatric illness or addiction problems that may compromise their ability to give informed consent or to comply with trial procedures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival (DFS is defined as the time from randomization until recurrence of tumor or death from any cause). Measuring time: every 3 months during 5 years<br>

Secondary Outcome Measures

Name	Time	Method
Overall survival (Time from randomization until death from any cause). Measuring time: 5 years<br>Adverse events (Description of any adverse event using CTCAE version 4). Measuring time: in every administration during 5 years.<br>Quality of Live (Questionnaire developed by INOR: CV-INOR- 26-(V.01)). Measuring time: at baseline and every 3 months during 5 years.<br>Immune response: antibody titers against neu GcGM3 (It will be positive when the inverse of the highest serum dilution giving optical density = 0.25 and twice the value of the pre-immune serum). Measuring time: at baseline and every 3 months during 5 years.<br>Ability to lyse ganglioside expressing cells (It will be positive if percentage of dead cells =20 %, after subtracting the pre-immune to hyper-immune percent). Measuring time: at baseline and every 3 months during 5 years.