Immunotherapy With Racotumomab in Advanced Lung Cancer

PHASE3UnknownINTERVENTIONAL
Enrollment

1,082

Participants

Timeline

Start Date

September 30, 2010

Primary Completion Date

September 30, 2016

Study Completion Date

September 30, 2016

Conditions
NSCLCLung 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.

Trial Locations (46)

Unknown

Instituto Médico CER, Quilmes

Hospital Privado de Córdoba, Córdoba

Instituto Oncológico de Córdoba, Córdoba

Fundación COIR, Mendoza

ISIS Clinica Especializada, Santa Fe

Policlínica Privada Instituto de Medicina Nuclear, Bahía Blanca

Hospital Italiano, Córdoba

Centro Oncológico de Rosario, Rosario

CRIO - Centro Regional Integrado de Oncologia, Fortaleza

NOB - Nucleo de Oncologia da Bahia, Salvador

Hospital Universitário de Brasília, Brasília

Pro Onco - Centro de Tratamento Oncológico, Londrina

Hospital da Cidade de Passo Fundo, Passo Fundo

UPCO - Unidade de Pesquisas Clínicas em Oncologia, Pelotas

HCPA - Hospital de Clínicas de Porto Alegre, Porto Alegre

Hospital de Base de São José do Rio Preto, São José do Rio Preto

Hospital Universitário de Brasília, Brasília - DF

Centro de Oncologia do Parana, Curitiba

CRIO - Centro Regional Integrado de Oncologia, Fortaleza - CE

Hospital Amaral de Carvalho, Jaú

Pro Onco - Centro de Tratamento Oncológico, Londrina - PR

Centro Oncologico de Mogi das Cruzes, Mogi das Cruzes

Liga Norte Riograndense Contra o Cancer, Natal

Hospital da Cidade de Passo Fundo, Passo Fundo - RS

UPCO - Unidade de Pesquisas Clínicas em Oncologia, Pelotas - RS

Hospital Moinhos de Vento, Porto Alegre

HCPA - Hospital de Clínicas de Porto Alegre, Porto Alegre - RS

Oncologistas Associados, Rio de Janeiro

NOB - Nucleo de Oncologia da Bahia, Salvador - BA

Faculdade de Medicina do ABC, Santo André

Hospital de Base de São José do Rio Preto, São José do Rio Preto

GRAM - Grupo de Assistencia Medica e Prestacao de Servicos, São Paulo

"Hospital Hermanos Ameijeiras", Havana

"Hospital Celestino Hernández Robau", Provincia de Villa Clara

Hospital Jose Ramon Lopez Tabranes, Versalles

Dr Moewardi Hospital, Central Java

Persahabatan Hospital, Jakarta

RS Kanker 'Dharmais', Jakarta

Dr Soetomo Hospital, Surabaya

Dr Sardjito Hospital, Yogyakarta

Perpetual Succour Hospital, Cebu City

Veterans Memorial Medical Center, Manila

Johns Hopkins Singapore International Medical Centre, Singapore

Chiang Mai Hospital, Chiang Mai

Khon Kaen Hospital, Division of Pulmonary and Critical Care Medicine, Khon Kaen

Songklanagarind Hospital - HOCC-PSU, Songkhla

All Listed Sponsors
collaborator

CIMAB (Cuba)

UNKNOWN

collaborator

Laboratorio Elea Phoenix S.A.

INDUSTRY

collaborator

Innogene Kalbiotech Pte. Ltd

INDUSTRY

collaborator

Eurofarma Laboratorios S.A.

INDUSTRY

lead

Recombio SL

INDUSTRY