Immunotherapy With Racotumomab in Advanced Lung Cancer

NCT01460472 | Unknown Phase 3 DMC

• 2 other identifiers: EC-AR-1E10 MAb-301ISRCTN47153584
• Study Type: interventional
• Target: 1,082
• Locations: 7 countries
• Sites: 46

Brief 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

Keywords

NSCLC; Lung cancer, small-cell; advanced lung cancer; therapeutic vaccine; anti-idiotypic vaccine; 1E10

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  A comparison of survival in the subgroup of inoperable stage IIIA and dry IIIB will be performed in 757 (approximately 70% of the study population)

  Until date of death or last censored observation, on average upto 17 months

Secondary Outcomes (47)

• Number of Participants with Adverse events as a measure of safety and tolerability

  Until death, on average during 17 months

• Progression Free Survival

  From randomization until date of first documented progression of disease, assessed as per RECIST 1.0 during an expected average of 17 months

• Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside

  Baseline

• Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside for Racotumomab Group

  Month 3

• Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside for Racotumomab Group

  Month 6

Study Arms (2)

Racotumomab plus Best Support Treatment

EXPERIMENTAL

Patients will receive Racotumomab and Best Support Treatment, which includes any further onco-specific therapy for progressive disease.

Biological: Racotumomab

Best Support Treatment

ACTIVE COMPARATOR

Patients will receive best support treatment for advanced NSCLC including onco-specific therapies when disease progresses.

Other: Best Support Treatment

Interventions

Racotumomab BIOLOGICAL

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.

Also known as: 1E10

Racotumomab plus Best Support Treatment

Best Support Treatment OTHER

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

Best Support Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily signed informed consent.
• Cytologic or histologically diagnosed NSCLC in stages IIIA (non-resectable) or IIIB or IV (TNM).
• In continuous complete or partial remission or stable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) after standard first-line treatment.
• Imaging studies documenting the response to first-line therapy must be available for evaluation by the investigator.
• Time lapse of 21 to 56 days between the end of onco-specific treatment and start of vaccination. Patients must have recovered from any acute toxicity produced by previous therapy.
• Age greater than or equal to 18 years, either sex.
• Eastern Cooperative Oncology Group performance status less than 2.
• Adequate organ function, defined as follows:
• Electrocardiogram (ECG) without significant anomalies, performed in the 7 days preceding entry
• Haemoglobin greater than or equal to 90 g/L
• Total white blood cell count (WBC) greater than or equal to 3.0 x 10\^9/L
• Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10\^9/L
• Platelet count greater than 100 x 10\^9/L
• Total bilirubin less than or equal to 1.5 fold the maximum normal value at the place of evaluation or 2.5 fold the maximum normal value in case of liver metastases
• Glutamic-oxaloacetic transaminase/aspartate aminotransferase (GOT/AST), and glutamic-pyruvic transaminase/alanine aminotransferase (GPT/ALT), less than or equal to 2.5 fold the maximum normal value at the place of evaluation (in case of liver metastasis, less than 5 fold the maximum normal value)

You may not qualify if:

• Pregnant or breastfeeding patients
• Known hypersensitivity to any component of the formulation
• Fertile patients of either sex who do not use adequate contraceptive methods while on treatment
• Disease progression prior to randomization
• Recurrent NSCLC, who relapse less than one year after completing curative intent therapy
• Patients receiving other investigational medication (including investigational immunotherapy for NSCLC) or having received such medication within 30 days before entering the protocol
• Autoimmune diseases or chronic decompensated diseases
• Acute allergic disorders or a history of severe allergic reactions
• Known brain metastases
• History of demyelinating disease or inflammatory disease of the central nervous system or the peripheral nervous system
• Non-controlled intercurrent diseases, including active infections, symptomatic congestive heart failure, unstable chest angina or heart arrhythmia, as well as mentally incapable patients
• Other malignant diseases except non- melanoma skin cancer, in situ carcinoma of the cervix, incidental prostate cancer (T1a, Gleason less than or equal to 6, prostate specific antigen (PSA) less than 0.5 ng/ml) or any other tumour having received adequate treatment and evidencing a disease-free period greater than or equal to 5 years
• Active hepatitis C or positive tests for human immunodeficiency virus (HIV)

Sponsors & Collaborators

• Recombio SL: lead
• CIMAB (Cuba): collaborator
• Laboratorio Elea Phoenix S.A.: collaborator
• Innogene Kalbiotech Pte. Ltd: collaborator
• Eurofarma Laboratorios S.A.: collaborator

Study Sites (46)

Instituto Médico CER

Quilmes, Buenos Aires, Argentina

Location

Hospital Privado de Córdoba

Córdoba, Córdoba Province, Argentina

Location

Instituto Oncológico de Córdoba

Córdoba, Córdoba Province, Argentina

Location

Fundación COIR

Mendoza, Mendoza Province, Argentina

Location

ISIS Clinica Especializada

Santa Fe, Santa Fe Province, Argentina

Location

Policlínica Privada Instituto de Medicina Nuclear

Bahía Blanca, Argentina

Location

Hospital Italiano

Córdoba, Argentina

Location

Centro Oncológico de Rosario

Rosario, Argentina

Location

CRIO - Centro Regional Integrado de Oncologia

Fortaleza, Ceará, Brazil

Location

NOB - Nucleo de Oncologia da Bahia

Salvador, Estado de Bahia, Brazil

Location

Hospital Universitário de Brasília

Brasília, Federal District, Brazil

Location

Pro Onco - Centro de Tratamento Oncológico

Londrina, Paraná, Brazil

Location

Hospital da Cidade de Passo Fundo

Passo Fundo, Rio Grande do Sul, Brazil

Location

UPCO - Unidade de Pesquisas Clínicas em Oncologia

Pelotas, Rio Grande do Sul, Brazil

Location

HCPA - Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital de Base de São José do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Location

Hospital Universitário de Brasília

Brasília - DF, Brazil

Location

Centro de Oncologia do Parana

Curitiba, Brazil

Location

CRIO - Centro Regional Integrado de Oncologia

Fortaleza - CE, Brazil

Location

Hospital Amaral de Carvalho

Jaú, Brazil

Location

Pro Onco - Centro de Tratamento Oncológico

Londrina - PR, Brazil

Location

Centro Oncologico de Mogi das Cruzes

Mogi das Cruzes, Brazil

Location

Liga Norte Riograndense Contra o Cancer

Natal, Brazil

Location

Hospital da Cidade de Passo Fundo

Passo Fundo - RS, Brazil

Location

UPCO - Unidade de Pesquisas Clínicas em Oncologia

Pelotas - RS, Brazil

Location

Hospital Moinhos de Vento

Porto Alegre, Brazil

Location

HCPA - Hospital de Clínicas de Porto Alegre

Porto Alegre - RS, Brazil

Location

Oncologistas Associados

Rio de Janeiro, Brazil

Location

NOB - Nucleo de Oncologia da Bahia

Salvador - BA, Brazil

Location

Faculdade de Medicina do ABC

Santo André, Brazil

Location

Hospital de Base de São José do Rio Preto

São José do Rio Preto, Brazil

Location

GRAM - Grupo de Assistencia Medica e Prestacao de Servicos

São Paulo, Brazil

Location

Hospital "Hermanos Ameijeiras"

Havana, Cuba

Location

Hospital "Celestino Hernández Robau"

Provincia de Villa Clara, Cuba

Location

Hospital Jose Ramon Lopez Tabranes

Versalles, Cuba

Location

Dr Moewardi Hospital

Central Java, Indonesia

Location

Persahabatan Hospital

Jakarta, Indonesia

Location

RS Kanker 'Dharmais'

Jakarta, Indonesia

Location

Dr Soetomo Hospital

Surabaya, Indonesia

Location

Dr Sardjito Hospital

Yogyakarta, Indonesia

Location

Perpetual Succour Hospital

Cebu City, Philippines

Location

Veterans Memorial Medical Center

Manila, Philippines

Location

Johns Hopkins Singapore International Medical Centre

Singapore, Singapore

Location

Chiang Mai Hospital

Chiang Mai, Thailand

Location

Khon Kaen Hospital, Division of Pulmonary and Critical Care Medicine

Khon Kaen, Thailand

Location

Songklanagarind Hospital - HOCC-PSU

Songkhla, Thailand

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

racotumomab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Roberto Gomez, M.D.

  Recombio S.L.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2011
• First Posted: October 26, 2011
• Study Start: September 1, 2010
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: July 29, 2016

Record last verified: 2016-07

Locations

ID (5); PH (2); TH (3); AR (8); SG (1); BR (24); CU (3)