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NSCLCPhase 3NCT01460472

Immunotherapy With Racotumomab in Advanced Lung Cancer

A Phase 3 study testing Racotumomab and Best Support Treatment in people with NSCLC and Lung Cancer, Non-small Cell, run by Recombio SL at 46 sites in 7 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC, Lung Cancer, Non-small Cell
What is being tested?
Racotumomab and Best Support Treatment
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,082 participants
Where
46 sitesin 7 countries
Study dates
Sep 2010to Sep 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 17Show fewer
  • Eastern Cooperative Oncology Group performance status less than 2.
  • 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)
  • Known hepatitis B virus carriers who have liver function tests within the accepted limits are eligible

Who cannot join

  • 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
Show all 14Show fewer
  • 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
  • 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.
  • Active hepatitis C or positive tests for human immunodeficiency virus (HIV)

Trial locations and contacts

46 sites in 7 countries.

46 sites in 7 countries

Brazil24 sites

  • Hospital Universitário de Brasília

    Brasília, Federal District

  • Hospital Universitário de Brasília

    Brasília - DF

  • Centro de Oncologia do Parana

    Curitiba

  • CRIO - Centro Regional Integrado de Oncologia

    Fortaleza, Ceará

  • CRIO - Centro Regional Integrado de Oncologia

    Fortaleza - CE

  • Hospital Amaral de Carvalho

    Jaú

  • Pro Onco - Centro de Tratamento Oncológico

    Londrina, Paraná

  • 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, Rio Grande do Sul

  • Hospital da Cidade de Passo Fundo

    Passo Fundo - RS

  • UPCO - Unidade de Pesquisas Clínicas em Oncologia

    Pelotas, Rio Grande do Sul

  • UPCO - Unidade de Pesquisas Clínicas em Oncologia

    Pelotas - RS

  • HCPA - Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul

  • 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, Estado de Bahia

  • 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, São Paulo

  • 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

Other trials in Brazil

Argentina8 sites

  • Policlínica Privada Instituto de Medicina Nuclear

    Bahía Blanca

  • Hospital Privado de Córdoba

    Córdoba, Córdoba Province

  • Instituto Oncológico de Córdoba

    Córdoba, Córdoba Province

  • Hospital Italiano

    Córdoba

  • Fundación COIR

    Mendoza, Mendoza Province

  • Instituto Médico CER

    Quilmes, Buenos Aires

  • Centro Oncológico de Rosario

    Rosario

  • ISIS Clinica Especializada

    Santa Fe, Santa Fe Province

Other trials in Argentina

Indonesia5 sites

  • Dr Moewardi Hospital

    Central Java

  • Persahabatan Hospital

    Jakarta

  • RS Kanker 'Dharmais'

    Jakarta

  • Dr Soetomo Hospital

    Surabaya

  • Dr Sardjito Hospital

    Yogyakarta

Other trials in Indonesia

Cuba3 sites

  • Hospital "Hermanos Ameijeiras"

    Havana

  • Hospital "Celestino Hernández Robau"

    Provincia de Villa Clara

  • Hospital Jose Ramon Lopez Tabranes

    Versalles

Other trials in Cuba

Thailand3 sites

  • Chiang Mai Hospital

    Chiang Mai

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

    Khon Kaen

  • Songklanagarind Hospital - HOCC-PSU

    Songkhla

Other trials in Thailand

Philippines2 sites

  • Perpetual Succour Hospital

    Cebu City

  • Veterans Memorial Medical Center

    Manila

Other trials in Philippines

Singapore1 site

  • Johns Hopkins Singapore International Medical Centre

    Singapore

Other trials in Singapore

About this study

Official title: A Prospective, Randomized, Multicenter, Open Label Phase III Study of Active Specific Immunotherapy With Racotumomab Plus Best Support Treatment Versus Best Support Treatment in Patients With Advanced Non-small Cell Lung Camcer.

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.

Being tested
Racotumomab, Best Support Treatment
Keywords
NSCLC, Lung cancer, small-cell, advanced lung cancer, therapeutic vaccine, anti-idiotypic vaccine, 1E10
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RacotumomabBiological

    Also called 1E10

    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 TreatmentOther

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

Study groups in NCT01460472
Study groupRoleWhat they receive
Racotumomab plus Best Support TreatmentExperimentalPatients will receive Racotumomab and Best Support Treatment, which includes any further onco-specific therapy for progressive disease.
Receives: Biological: Racotumomab
Best Support TreatmentActive comparatorPatients will receive best support treatment for advanced NSCLC including onco-specific therapies when disease progresses.
Receives: Other: Best Support Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

Secondary outcomes (47)

  1. 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.

    Measured: Until death, on average during 17 months

  2. Progression Free Survival

    Tumour evaluations will be performed every 2 months and evaluated as per Response Evaluation Criteria in Solid Tumors (RECIST).

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

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

    Measured: Baseline

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

    Measured: Month 3

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

    Measured: Month 6

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

    Measured: Month 9

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

    Measured: Month 12

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

    Measured: After the first year, every 3 months, on average for 17 months

  9. Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay.

    Measured: Baseline

  10. Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay for Racotumomab Group.

    Measured: Month 3

  11. Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay for Racotumomab Group.

    Measured: Month 6

  12. Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay for Racotumomab Group.

    Measured: Month 9

  13. Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay for Racotumomab Group.

    Measured: Month 12

  14. Evaluation of the reactivity if the antibodies against X63 tumor line (mouse myeloma) for Racotumomab Group

    Measured: Baseline

  15. Evaluation of the reactivity if the antibodies against X63 tumor line (mouse yeloma) for Racotumomab Group

    Measured: Month 3

  16. Evaluation of the reactivity if the antibodies against X63 tumor line (mouse myeloma) for Racotumomab Group

    Measured: Month 6

  17. Evaluation of the reactivity if the antibodies against X63 tumor line (mouse myeloma) for Racotumomab Group

    Measured: Month 9

  18. Evaluation of the reactivity if the antibodies against X63 tumor line (mouse myeloma) for Racotumomab Group

    Measured: Month 12

  19. Evaluation of the reactivity if the antibodies against X63 tumor line (mouse myeloma) for Best Support Treatment Group

    Measured: Baseline

  20. Evaluation of the reactivity if the antibodies against X63 tumor line (mouse myeloma) for Best Support Treatment Group

    Measured: Month 4

  21. Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside for Best Support Treatment Group

    Measured: Baseline

  22. Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside for Best Support Treatment Group

    Measured: Month 4

  23. Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay for Best Support Treatment Group.

    Measured: Month 4

  24. Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry.

    Measured: Baseline

  25. Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry in the Racotumomab Group.

    Measured: Month 3

  26. Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry in the Racotumomab Group.

    Measured: Month 6

  27. Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry in the Racotumomab Group.

    Measured: Month 9

  28. Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry in the Racotumomab Group.

    Measured: Month 12

  29. Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry in the Best Support Treatment Group.

    Measured: Month 4

  30. Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available)

    Measured: Baseline

  31. Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available) in the Racotumomab Group.

    Measured: Month 3

  32. Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available) in the Racotumomab Group.

    Measured: Month 6

  33. Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available) in the Racotumomab Group.

    Measured: Month 9

  34. Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available) in the Racotumomab Group.

    Measured: Month 12

  35. Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available) in the Best Support Treatment Group.

    Measured: Month 4

  36. Measurement of pro-inflammatory and anti-inflammatory cytokines

    Measured: Baseline

  37. Measurement of pro-inflammatory and anti-inflammatory cytokines in the Racotumomab Group

    Measured: Month 3

  38. Measurement of pro-inflammatory and anti-inflammatory cytokines in the Racotumomab Group

    Measured: Month 6

  39. Measurement of pro-inflammatory and anti-inflammatory cytokines in the Racotumomab Group

    Measured: Month 9

  40. Measurement of pro-inflammatory and anti-inflammatory cytokines in the Racotumomab Group

    Measured: Month 12

  41. Measurement of pro-inflammatory and anti-inflammatory cytokines in the Best Support Treatment Group

    Measured: Month 4

  42. Determination of anti-idiotypic IgG response

    Measured: Baseline

  43. Determination of anti-idiotypic IgG response in the Racotumomab Group.

    Measured: Month 3

  44. Determination of anti-idiotypic IgG response in the Racotumomab Group.

    Measured: Month 6

  45. Determination of anti-idiotypic IgG response in the Racotumomab Group.

    Measured: Month 9

  46. Determination of anti-idiotypic IgG response in the Racotumomab Group.

    Measured: Month 12

  47. Determination of anti-idiotypic IgG response in the Best Support Treatment Group.

    Measured: Month 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2011 (estimated)
  2. Study startSep 2010
  3. Primary completionSep 2016 (estimated)
  4. Study completionSep 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,082 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01460472
Sponsor's protocol ID
EC-AR-1E10 MAb-301
Other IDs
ISRCTN47153584
Status last verified
Jul 2016
First submitted
23 Oct 2011
Last updated
29 Jul 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Racotumomab and Best Support Treatment in people with NSCLC and Lung Cancer, Non-small Cell, run by Recombio SL at 46 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in Brazil, Argentina, Indonesia, Cuba, Thailand and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: Until date of death or last censored observation, on average upto 17 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01460472.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.

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