Predictor of response with CIMAvax EGF© in NSCLC Phase III

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Survival of patients with advanced Non Small Cells Lung Cancer and EGF concentration in sera highest than 870 pg/mL that receive CIMAvax EGF© as maintenance therapy.

Secondary indentifying numbers:

EC151

Issuing authority of the secondary identifying numbers:

Centre for Molecular Immunology

Source(s) of monetary or material support:

Centre for Molecular Immunology Cuban Ministry of Public Health

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Authorization date :

04/10/2013

Reference number:

05.009.13BC

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Elia

Last name:

Neninger Vinageras

Medical Specialty :

Second Degree Specialist in Oncology

Affiliation:

Hermanos Ameijeiras Hospital

Postal address:

San Lazaro Street, 701. Centro Habana

City:

Havana

Country:

Cuba

Zip Code:

10300

Telephone:

+53-78761926

Email address:

nenin@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana, Enrique Cabrera Hospital, Janet Menendez Alfonso MD, First Degree Specialist in Oncology

Research ethics committees:

Hermanos Ameijeriras Hospital, June 3rd, 2013

Enrique Cabrera Hospital, May 15th,2013

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Recruiting

Date of first enrollment:

26/09/2014

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Non small cell lung cancer

Health condition(s) code:

Carcinoma, Non-Small-Cell Lung

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Intervention(s):

Experimental Group: Vaccine CIMAvax EGF + Best Supportive Care (BSC). The 2.4 mg doses of vaccine will be administered by intramuscular route 4 bi-weekly immunizations and 1 monthly immunizations until ECOG 3-4. The BSC treatment will be composed by Analgesics or opioids if pain, oxigen if disnea, and psychotherapy, steroids, palliative radiation or gastrointestinal medication if needed. Control Group: Best Supportive Care (BSC). The BSC treatment will be composed by Analgesics or opioids if pain, oxigen if disnea, and psychotherapy, steroids, palliative radiation or gastrointestinal medication if needed.

Intervention keyword:

Therapeutic vaccine CIMAvax-EGF

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Overall Survival (time from randomization until death from any cause). Measuring time: 3,6,9,12,18, 24 months.

Key secondary outcomes:

Anti-EGF antibodies titers (serum dilutions). Measuring time: At baseline, quaterly during 4 first immunizations and then monthly in every immunization. Serum EGF concentration (pg/mL). Measuring time: At baseline, at month six and at month 12. Adverse Events-AE (Type: name of AE; Intensity: Mild, Moderate, Severe, Life- threatening, Death according to CTCAE version 4.0; Gravity: Serious, Not serious; Duration: Difference between the start and end dates of AE; Attitude to the drug: No change, Dose modification, Temporary interruption, Discontinuance of treatment; outcome of EA: recovered, improved, persists or squeals; Causality relationship (Very Likely, Likely, Possible, Not related, Unknown). Measuring time: 3,6,9,12,18, 24 months.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

Inclusion criteria:

1. Have histologically and/or cytologically confirmed diagnosis of NSCLC, corresponding to locally and regionally advanced, inoperable disease (Stage IIIb or Stage IV 2. Aged >18 years 3. EGF serum concentration > 870 pg/mL 4. Have adequate bone marrow, liver and renal function, as assessed by the Investigator. A sample taken at Screening should confirm that: - Hemoglobin ≥ 9 g/L - White blood cell (WBC) count ≥ 3000/ μL - Neutrophils ≥ 1500/μL - Platelet count ≥ 100,000 per μL - Total bilirrubin in normal labs values - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) Serum creatinine ≤ 1.5 x ULN 5. Life expectancy at least 3 years 6. Agree to use double-barrier contraception (males and females alike [if applicable]). A negative pregnancy test must be documented at Screening for females of childbearing potential. 7. Females of childbearing potential are defined as those women with less than 2 years after last menstruation and not surgically sterile, while post-menopausal refers to those women with at least 2 years from last menstruation. 8. Have signed a voluntary written informed consent form (ICF). Patients should be cooperative, willing and able to participate and adhere to the Protocol requirements, including their availability for the follow-up. 9. Are eligible to receive first-line chemotherapy (without concurrent thoracic radiotherapy or consolidation radiotherapy). 10. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 11. Achieve tumor Objective Response of at least stable disease by RECIST

Exclusion criteria:

1. EGF serum concentration ≤ 870 pg/mL 2. Patient is currently enrolled in other investigational drug trial. 3. Patient has a history of any severe or life-threatening hypersensitivity reaction. 4. Patient has an unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal and metabolic disease). 5. Pregnant woman6. Another active concurrent malignant disease except non- melanoma skin lesions or cervix cancer. 6. Brain metastases (Only if detectable by radiological image scan previous sign or symptoms)

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

No intervention

Study design:

Parallel

Phase:

3

Target sample size:

100

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Roselin

Last Name:

Valle Cabrera

Specialty:

Bachelor of Pharmaceutical Sciences, Master of Clinical Pharmacy

Affiliation:

National Coordinating Center of Clinical Trials (CENCEC)

Postal Address:

5ta A e/ 60 y 62 Miramar, Playa, La Habana

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

537-2164224

Email :

roselin@cencec.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Pedro

Middle Name:

Camilo

Last Name:

Rodriguez

Specialty:

Second Degree Specialist in Pharmacolgy

Affiliation:

Center for Molecular Immunology

Postal Address:

216 st. & 15 ave. Atabey Playa. PO. Box 16042

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

537- 2717933 Ext 3489

Email :

camilo@cim.sld.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000208

Date of Registration in Primary Registry:

29/01/2016

Record Verification Date:

2016/01/29

Next update date:

2017/01/29

Link to the spanish version:

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Predictor of response with CIMAvax EGF© in NSCLC Phase III

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