Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01460472
Other study ID # EC-AR-1E10 MAb-301
Secondary ID ISRCTN47153584
Status Active, not recruiting
Phase Phase 3
First received October 23, 2011
Last updated July 28, 2016
Start date September 2010
Est. completion date September 2016

Study information

Verified date July 2016
Source Recombio SL
Contact n/a
Is FDA regulated No
Health authority Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaBrazil: National Committee of Ethics in ResearchCuba: Ministry of Public HealthIndonesia:BPOM-Badan Pengawas Obat dan Makanan aka National Agency for Drug and Food ControlPhilippines: Bureau of Food and DrugsThailand:TFDA-Thailand Food and Drug AdministrationUruguay: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1082
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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.

Locations

Country Name City State
Argentina Policlínica Privada Instituto de Medicina Nuclear Bahía Blanca
Argentina Hospital Italiano Córdoba
Argentina Hospital Privado de Córdoba Córdoba
Argentina Instituto Oncológico de Córdoba Córdoba
Argentina Fundación COIR Mendoza
Argentina Instituto Médico CER Quilmes Buenos Aires
Argentina Centro Oncológico de Rosario Rosario
Argentina ISIS Clinica Especializada Santa Fe
Brazil Hospital Universitário de Brasília Brasília DF
Brazil Hospital Universitário de Brasília Brasília - DF
Brazil Centro de Oncologia do Parana Curitiba
Brazil CRIO - Centro Regional Integrado de Oncologia Fortaleza CE
Brazil CRIO - Centro Regional Integrado de Oncologia Fortaleza - CE
Brazil Hospital Amaral de Carvalho Jau
Brazil Pro Onco - Centro de Tratamento Oncológico Londrina PR
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 Hospital da Cidade de Passo Fundo Passo Fundo - RS
Brazil UPCO - Unidade de Pesquisas Clínicas em Oncologia Pelotas RS
Brazil UPCO - Unidade de Pesquisas Clínicas em Oncologia Pelotas - RS
Brazil HCPA - Hospital de Clínicas de Porto Alegre Porto Alegre 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 NOB - Nucleo de Oncologia da Bahia Salvador - BA
Brazil Faculdade de Medicina do ABC Santo Andre
Brazil Hospital de Base de São José do Rio Preto São José do Rio Preto SP
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 Sao Paulo
Cuba Hospital "Hermanos Ameijeiras" Havana
Cuba Hospital "Celestino Hernández Robau" Provincia de Villa Clara
Cuba Hospital Jose Ramon Lopez Tabranes Versalles
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
Philippines Perpetual Succour Hospital Cebu City
Philippines Veterans Memorial Medical Center Manila
Singapore Johns Hopkins Singapore International Medical Centre Singapore
Thailand Chiang Mai Hospital Chiang Mai
Thailand Khon Kaen Hospital, Division of Pulmonary and Critical Care Medicine Khon Kaen
Thailand Songklanagarind Hospital - HOCC-PSU Songkhla

Sponsors (5)

Lead Sponsor Collaborator
Recombio SL CIMAB (Cuba), Eurofarma Laboratorios S.A., Innogene Kalbiotech Pte. Ltd, Laboratorio Elea S.A.C.I.F. y A.

Countries where clinical trial is conducted

Argentina,  Brazil,  Cuba,  Indonesia,  Philippines,  Singapore,  Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Number of Participants with Adverse events as a measure of safety and tolerability Safety will be evaluated at each study visit according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 and will include physical examination with vital signs, performance status as per the Eastern Cooperative Oncology Group scale(ECOG scale), laboratory tests and clinical history. Until death, on average during 17 months Yes
Secondary Progression Free Survival Tumour evaluations will be performed every 2 months and evaluated as per Response Evaluation Criteria in Solid Tumors (RECIST). From randomization until date of first documented progression of disease, assessed as per RECIST 1.0 during an expected average of 17 months No
Secondary Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside Baseline No
Secondary Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside for Racotumomab Group Month 3 No
Secondary Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside for Racotumomab Group Month 6 No
Secondary Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside for Racotumomab Group Month 9 No
Secondary Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside for Racotumomab Group Month 12 No
Secondary Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside for Racotumomab Group After the first year, every 3 months, on average for 17 months No
Secondary Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay. Baseline No
Secondary Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay for Racotumomab Group. Month 3 No
Secondary Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay for Racotumomab Group. Month 6 No
Secondary Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay for Racotumomab Group. Month 9 No
Secondary Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay for Racotumomab Group. Month 12 No
Secondary Evaluation of the reactivity if the antibodies against X63 tumor line (mouse myeloma) for Racotumomab Group Baseline No
Secondary Evaluation of the reactivity if the antibodies against X63 tumor line (mouse yeloma) for Racotumomab Group Month 3 No
Secondary Evaluation of the reactivity if the antibodies against X63 tumor line (mouse myeloma) for Racotumomab Group Month 6 No
Secondary Evaluation of the reactivity if the antibodies against X63 tumor line (mouse myeloma) for Racotumomab Group Month 9 No
Secondary Evaluation of the reactivity if the antibodies against X63 tumor line (mouse myeloma) for Racotumomab Group Month 12 No
Secondary Evaluation of the reactivity if the antibodies against X63 tumor line (mouse myeloma) for Best Support Treatment Group Baseline No
Secondary Evaluation of the reactivity if the antibodies against X63 tumor line (mouse myeloma) for Best Support Treatment Group Month 4 No
Secondary Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside for Best Support Treatment Group Baseline No
Secondary Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside for Best Support Treatment Group Month 4 No
Secondary Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay for Best Support Treatment Group. Month 4 No
Secondary Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry. Baseline No
Secondary Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry in the Racotumomab Group. Month 3 No
Secondary Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry in the Racotumomab Group. Month 6 No
Secondary Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry in the Racotumomab Group. Month 9 No
Secondary Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry in the Racotumomab Group. Month 12 No
Secondary Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry in the Best Support Treatment Group. Month 4 No
Secondary Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available) Baseline No
Secondary Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available) in the Racotumomab Group. Month 3 No
Secondary Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available) in the Racotumomab Group. Month 6 No
Secondary Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available) in the Racotumomab Group. Month 9 No
Secondary Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available) in the Racotumomab Group. Month 12 No
Secondary Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available) in the Best Support Treatment Group. Month 4 No
Secondary Measurement of pro-inflammatory and anti-inflammatory cytokines Baseline No
Secondary Measurement of pro-inflammatory and anti-inflammatory cytokines in the Racotumomab Group Month 3 No
Secondary Measurement of pro-inflammatory and anti-inflammatory cytokines in the Racotumomab Group Month 6 No
Secondary Measurement of pro-inflammatory and anti-inflammatory cytokines in the Racotumomab Group Month 9 No
Secondary Measurement of pro-inflammatory and anti-inflammatory cytokines in the Racotumomab Group Month 12 No
Secondary Measurement of pro-inflammatory and anti-inflammatory cytokines in the Best Support Treatment Group Month 4 No
Secondary Determination of anti-idiotypic IgG response Baseline No
Secondary Determination of anti-idiotypic IgG response in the Racotumomab Group. Month 3 No
Secondary Determination of anti-idiotypic IgG response in the Racotumomab Group. Month 6 No
Secondary Determination of anti-idiotypic IgG response in the Racotumomab Group. Month 9 No
Secondary Determination of anti-idiotypic IgG response in the Racotumomab Group. Month 12 No
Secondary Determination of anti-idiotypic IgG response in the Best Support Treatment Group. Month 4 No
See also
  Status Clinical Trial Phase
Recruiting NCT05821933 - RC108 Combine With Furmonertinib With/Without Toripalimab in Patients With EGFR-mutated NSCLC Phase 1/Phase 2
Active, not recruiting NCT03269162 - Postoperative NSCLC Treated With Integrated Medicine Base on Circulating Tumor Cell Detection Phase 3
Recruiting NCT05002270 - JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation Phase 1/Phase 2
Recruiting NCT06315686 - The Dynamic Monitoring of Cerebrospinal Fluid ctDNA Phase 2
Active, not recruiting NCT05059522 - Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Phase 3
Recruiting NCT05466149 - Efficacy and Safety of Furmonertinib in Patients With Locally Advanced or Metastatic NSCLC With EGFR Exon 20 Insertion Phase 2
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Completed NCT03609918 - Comprehensive Analysis of Gene Mutation Profile in Chinese NSCLC Patients by Next-generation Sequencing
Recruiting NCT06043817 - First-In-Human Study of STX-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Phase 1/Phase 2
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Recruiting NCT05078931 - A Study to Evaluate Pembrolizumab Plus Lenvatinib in PD-L1 Positive TKI Resistant NSCLC Patients Phase 2
Not yet recruiting NCT05547737 - Multicenter, Prospective, Real World Study of Camrelizumab in Cross-line Treatment of Non-small Cell Lung Cancer
Not yet recruiting NCT05909137 - Omitting Clinical Target Volume in Radical Treatment of Unresectable Stage III Non-small Cell Lung Cancer
Withdrawn NCT05959473 - EGFR_IUO 3.20 Clinical Study Protocol N/A
Not yet recruiting NCT05005468 - A Phase II Trial of Camrelizumab Combined With Famitinib for Adjuvant Treatment of Stage II-IIIA NSCLC. Phase 2
Recruiting NCT01690390 - Dose Escalation of Icotinib in Advanced Non-small Cell Lung Carcinoma (NSCLC) Patients Evaluated as Stable Disease Phase 2
Completed NCT01852578 - Cabazitaxel in Relapsed and Metastatic NSCLC Phase 2
Completed NCT00866970 - Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-related Fatigue and Cachexia Phase 2
Completed NCT00702975 - Study of Combination Therapy of Carboplatin -Gemcitabine Plus Bevacizumab Beyond Progression in Patients With Locally Advanced and/or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Not Received Prior Systemic Therapy Phase 2
Withdrawn NCT00576225 - CT-2103/Carboplatin vs Paclitaxel/Carboplatin for NSCLC in Women With Estradiol > 25 pg/mL Phase 3