Immunotherapy With Racotumomab in Advanced Lung Cancer

NCT ID: NCT01460472

Last Updated: 2016-07-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 1082 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2016-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Racotumomab plus Best Support Treatment

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

Group Type: EXPERIMENTAL

Racotumomab

Intervention Type: 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.

Best Support Treatment

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

Group Type: ACTIVE_COMPARATOR

Best Support Treatment

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: OTHER

Other Intervention Names

1E10

Eligibility Criteria

Inclusion Criteria

1. Voluntarily signed informed consent.

2. Cytologic or histologically diagnosed NSCLC in stages IIIA (non-resectable) or IIIB or IV (TNM).

3. In continuous complete or partial remission or stable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) after standard first-line treatment.

4. Imaging studies documenting the response to first-line therapy must be available for evaluation by the investigator.

5. 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.

6. Age greater than or equal to 18 years, either sex.

7. Eastern Cooperative Oncology Group performance status less than 2.

8. Adequate organ function, defined as follows:

8.1. Electrocardiogram (ECG) without significant anomalies, performed in the 7 days preceding entry

8.2. Haemoglobin greater than or equal to 90 g/L

8.3. Total white blood cell count (WBC) greater than or equal to 3.0 x 10^9/L

8.4. Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L

8.5. Platelet count greater than 100 x 10^9/L

8.6. 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

8.7. 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)

8.8. Creatinine less than or equal to 2 mg/dL (less than or equal to 176 µmol/L)

9. Known hepatitis B virus carriers who have liver function tests within the accepted limits are eligible

Exclusion Criteria

1. Pregnant or breastfeeding patients

2. Known hypersensitivity to any component of the formulation

3. Fertile patients of either sex who do not use adequate contraceptive methods while on treatment

4. Disease progression prior to randomization

5. Recurrent NSCLC, who relapse less than one year after completing curative intent therapy

6. Patients receiving other investigational medication (including investigational immunotherapy for NSCLC) or having received such medication within 30 days before entering the protocol

7. Autoimmune diseases or chronic decompensated diseases

8. Acute allergic disorders or a history of severe allergic reactions

9. Known brain metastases

10. History of demyelinating disease or inflammatory disease of the central nervous system or the peripheral nervous system

11. Non-controlled intercurrent diseases, including active infections, symptomatic congestive heart failure, unstable chest angina or heart arrhythmia, as well as mentally incapable patients

12. 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

13. Receiving chronic therapy for more than 10 days at doses of prednisone greater than 10 mg/day (or equivalent) at the moment of the inclusion. Inhaled and topical corticosteroids are allowed.

14. Active hepatitis C or positive tests for human immunodeficiency virus (HIV)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CIMAB (Cuba)

UNKNOWN

Sponsor Role: collaborator

Laboratorio Elea Phoenix S.A.

INDUSTRY

Sponsor Role: collaborator

Innogene Kalbiotech Pte. Ltd

INDUSTRY

Sponsor Role: collaborator

Eurofarma Laboratorios S.A.

INDUSTRY

Sponsor Role: collaborator

Recombio SL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roberto Gomez, M.D.

Role: STUDY_DIRECTOR

Recombio S.L.

Locations

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

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

Hospital "Hermanos Ameijeiras"

Havana, , Cuba

Hospital "Celestino Hernández Robau"

Provincia de Villa Clara, , Cuba

Hospital Jose Ramon Lopez Tabranes

Versalles, , Cuba

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

Perpetual Succour Hospital

Cebu City, , Philippines

Veterans Memorial Medical Center

Manila, , Philippines

Johns Hopkins Singapore International Medical Centre

Singapore, , Singapore

Chiang Mai Hospital

Chiang Mai, , Thailand

Khon Kaen Hospital, Division of Pulmonary and Critical Care Medicine

Khon Kaen, , Thailand

Songklanagarind Hospital - HOCC-PSU

Songkhla, , Thailand

Countries

Argentina; Brazil; Cuba; Indonesia; Philippines; Singapore; Thailand

Other Identifiers

ISRCTN47153584

Identifier Type: REGISTRY

Identifier Source: secondary_id

EC-AR-1E10 MAb-301

Identifier Type: -

Identifier Source: org_study_id