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Immunotherapy With Racotumomab Versus Support Treatment in Advanced Non-small Cell Lung Cancer Patients

NCT01240447 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2014-07-10

No results posted yet for this study

Summary

This study is designed to evaluate safety and immunogenicity of racotumomab in patients with advanced Non-small Cell Lung Cancer (NSCLC), in concomitance with chemotherapy (docetaxel) when a second-line therapy is indicated. The study will also compare survival and progression free survival on both study arms.

Conditions

Interventions

BIOLOGICAL

racotumomab

Patients will receive best support treatment and vaccination with racotumomab. The vaccination schedule is as follows: 5 doses (1mg/mL each), subcutaneously, every 2 weeks (induction period) followed by monthly vaccinations until any criteria for discontinuation are met. If disease progression occurs and a second line therapy is indicated, the patient will only be able to continue in the study if the drug indicated is docetaxel. Vaccination will not be interrupted during docetaxel administration unless criteria for vaccine discontinuation are met.

OTHER

Best support treatment

Patients will receive best support treatment as indicated by the investigator. In case a second line therapy is indicated, docetaxel is the only drug allowed to continue in the study.

Sponsors & Collaborators

  • Laboratorio Elea Phoenix S.A.

    lead INDUSTRY

Principal Investigators

  • Gabriela Cinat, MD · Instituto de Oncología "Angel H. Roffo"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-08-31
Completion
2014-06-30

Countries

  • Argentina

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01240447 on ClinicalTrials.gov