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.

Recombio SL38 sites in 7 countries1,082 target enrollmentSeptember 2010

ConditionsNSCLC Lung Cancer, Non-small Cell

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: NSCLC
Sponsor: Recombio SL
Enrollment: 1082
Locations: 38
Primary Endpoint: Overall Survival
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

September 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Recombio SL

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•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

Exclusion Criteria

•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

Outcomes

Primary Outcomes

Overall Survival

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

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)

Secondary Outcomes

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)
Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay for Racotumomab Group.(Month 12)
Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay for Best Support Treatment Group.(Month 4)
Number of Participants with Adverse events as a measure of safety and tolerability(Until death, on average during 17 months)
Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside(Baseline)
Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay.(Baseline)
Evaluation of the reactivity if the antibodies against X63 tumor line (mouse myeloma) for Racotumomab Group(Month 12)
Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside for Best Support Treatment Group(Month 4)
Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry.(Baseline)
Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry in the Racotumomab Group.(Month 12)
Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry in the Best Support Treatment Group.(Month 4)
Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available)(Baseline)
Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available) in the Racotumomab Group.(Month 12)
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)
Evaluation of the reactivity if the antibodies against X63 tumor line (mouse myeloma) for Best Support Treatment Group(Month 4)
Evaluation of the reactivity if the antibodies against X63 tumor line (mouse yeloma) for Racotumomab Group(Month 3)
Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available) in the Best Support Treatment Group.(Month 4)
Measurement of pro-inflammatory and anti-inflammatory cytokines(Baseline)
Determination of anti-idiotypic IgG response in the Racotumomab Group.(Month 12)
Measurement of pro-inflammatory and anti-inflammatory cytokines in the Racotumomab Group(Month 12)
Measurement of pro-inflammatory and anti-inflammatory cytokines in the Best Support Treatment Group(Month 4)
Determination of anti-idiotypic IgG response(Baseline)
Determination of anti-idiotypic IgG response in the Best Support Treatment Group.(Month 4)