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Immunotherapy With Racotumomab in Advanced Lung Cancer

NCT01460472 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1082

Last updated 2016-07-29

No results posted yet for this study

Summary

This is a prospective, randomized, open label, parallel-group, multicenter phase III study to evaluate the efficacy and safety of active specific immunotherapy with racotumomab plus best supportive care versus best supportive care in patients with advanced NSCLC who have achieved an Objective Response (Partial or Complete Response) or Stable Disease with standard first-line treatment. Also immunological parameters will be evaluated. Best supportive therapy will be administered to all patients in the study according to institutional standards and includes any subsequent onco-specific therapies. 1082 patients will be included in the study, with non-small cell lung cancer in stages IIIA (non-resectable), IIIB or IV.

Conditions

  • NSCLC
  • Lung Cancer, Non-small Cell

Interventions

BIOLOGICAL

Racotumomab

Patients will receive best support treatment and vaccination with racotumomab. The vaccination schedule is as follows: 5 doses (1mg/mL each), intradermally, every 2 weeks (induction period) followed by monthly vaccinations until any criteria for discontinuation are met. If disease progression occurs and further onco-specific therapy is indicated, the patient will be able to continue in the study and vaccination will not be interrupted unless criteria for vaccine discontinuation are met.

OTHER

Best Support Treatment

Patients will receive best support treatment for advanced NSCLC as per each institution's standards, including onco-specific therapies when disease progresses.

Sponsors & Collaborators

  • CIMAB (Cuba)

    collaborator UNKNOWN

  • Laboratorio Elea Phoenix S.A.

    collaborator INDUSTRY

  • Innogene Kalbiotech Pte. Ltd

    collaborator INDUSTRY

  • Eurofarma Laboratorios S.A.

    collaborator INDUSTRY

  • Recombio SL

    lead INDUSTRY

Principal Investigators

  • Roberto Gomez, M.D. · Recombio S.L.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • Argentina
  • Brazil
  • Cuba
  • Indonesia
  • Philippines
  • Singapore
  • Thailand

Study Locations

More Related Trials

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 NCT01460472 on ClinicalTrials.gov