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Clinical trialNCT01460472UnknownPhase 3Interventional

Immunotherapy With Racotumomab in Advanced Lung Cancer

SponsorRecombio SLEnrollment1,082Lung Cancer, Non-small CellNSCLC
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

46 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Argentina
  • Instituto Médico Cer

    Quilmes, Buenos Aires, Argentina

  • Hospital Privado de Córdoba

    Córdoba, Córdoba Province, Argentina

  • Instituto Oncológico de Córdoba

    Córdoba, Córdoba Province, Argentina

  • Fundación Coir

    Mendoza, Mendoza Province, Argentina

  • Isis Clinica Especializada

    Santa Fe, Santa Fe Province, Argentina

  • Policlínica Privada Instituto de Medicina Nuclear

    Bahía Blanca, Argentina

  • Hospital Italiano

    Córdoba, Argentina

  • Centro Oncológico de Rosario

    Rosario, Argentina

Brazil
  • Crio - Centro Regional Integrado de Oncologia

    Fortaleza, Ceará, Brazil

  • Nob - Nucleo de Oncologia Da Bahia

    Salvador, Estado de Bahia, Brazil

  • Hospital Universitário de Brasília

    Brasília, Federal District, Brazil

  • Pro Onco - Centro de Tratamento Oncológico

    Londrina, Paraná, Brazil

  • Hospital Da Cidade de Passo Fundo

    Passo Fundo, Rio Grande do Sul, Brazil

  • Upco - Unidade de Pesquisas Clínicas Em Oncologia

    Pelotas, Rio Grande do Sul, Brazil

  • Hcpa - Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, Brazil

  • Hospital de Base de São José Do Rio Preto

    São José do Rio Preto, São Paulo, Brazil

  • Hospital Universitário de Brasília

    Brasília - DF, Brazil

  • Centro de Oncologia Do Parana

    Curitiba, Brazil

  • Crio - Centro Regional Integrado de Oncologia

    Fortaleza - CE, Brazil

  • Hospital Amaral de Carvalho

    Jaú, Brazil

  • Pro Onco - Centro de Tratamento Oncológico

    Londrina - PR, Brazil

  • Centro Oncologico de Mogi Das Cruzes

    Mogi das Cruzes, Brazil

  • Liga Norte Riograndense Contra O Cancer

    Natal, Brazil

  • Hospital Da Cidade de Passo Fundo

    Passo Fundo - RS, Brazil

  • Upco - Unidade de Pesquisas Clínicas Em Oncologia

    Pelotas - RS, Brazil

  • Hospital Moinhos de Vento

    Porto Alegre, Brazil

  • Hcpa - Hospital de Clínicas de Porto Alegre

    Porto Alegre - RS, Brazil

  • Oncologistas Associados

    Rio de Janeiro, Brazil

  • Nob - Nucleo de Oncologia Da Bahia

    Salvador - BA, Brazil

  • Faculdade de Medicina Do Abc

    Santo André, Brazil

  • Hospital de Base de São José Do Rio Preto

    São José do Rio Preto, Brazil

  • Gram - Grupo de Assistencia Medica E Prestacao de Servicos

    São Paulo, Brazil

Cuba
  • Hospital "hermanos Ameijeiras"

    Havana, Cuba

  • Hospital "celestino Hernández Robau"

    Provincia de Villa Clara, Cuba

  • Hospital Jose Ramon Lopez Tabranes

    Versalles, Cuba

Indonesia
  • Dr Moewardi Hospital

    Central Java, Indonesia

  • Persahabatan Hospital

    Jakarta, Indonesia

  • Rs Kanker 'Dharmais'

    Jakarta, Indonesia

  • Dr Soetomo Hospital

    Surabaya, Indonesia

  • Dr Sardjito Hospital

    Yogyakarta, Indonesia

6 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Racotumomab
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Sept 2010
Primary completion
30 Sept 2016
Completion
30 Sept 2016
Last update posted
29 Jul 2016
Registered enrollment
1,082
Registry id
NCT01460472

Cross-registrations

ISRCTN (UK)ISRCTN47153584
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.