GcGM3/VSSP in small cell lung cancer

Phase 1

Recruiting

• Conditions: Small cell lung cancer; Carcinoma, Bronchogenic; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Bronchial Neoplasms; Small Cell Lung Carcinoma

• Registration Number: RPCEC00000224
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Patients with measurable lesions by application of RECIST version 1.1.
2.Patients older than 18 years.
3.Patients who consent to participate in the study by signing the informed consent model.
4.Patients with ECOG scale of Performance Status = 2.
5.Patients with normal functioning of organs and bone marrow defined by laboratory parameters.

Exclusion Criteria

1.Patients who have been treated with NGcGm3 / VSSP within 6 months prior to recruited.
2.Patients who have been included in another clinical trial within 6 months prior to recruited.
3.Patients who are pregnant or breastfeeding.
4.Patients with brain metastases.
5.Patients with acute or chronic infectious diseases.
6.Patients with a history of allergy attributed to compounds of chemical or biological composition similar to the vaccine.
7.Patients with autoimmune diseases.
8.Patients with descompensated chronic diseases.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serious Adverse Events related to the vaccine (Adverse Events serious” with causality relationship very probable” or probable”). Measuring time: Every 3 months until 20 months<br>Overall Survival (Time from the date of each patient randomization until the date of death, regardless of the cause of death). Measuring time: 20 months. <br>