Predictor of response with CIMAvax EGF© in NSCLC Phase III

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000208
• Date of registration: 29/01/2016
• Prospective Registration: No
• Primary sponsor: Centre for Molecular Immunology
• Public title: Predictor of response with CIMAvax EGF© in NSCLC Phase III
• 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.
• Date of first enrolment: 26/09/2014
• Target sample size: 100
• Recruitment status: Recruiting
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000208-En
• Study type: Interventional
• Study design: Allocation: Randomized controlled trial. Masking: Open. Control group: No intervention. Assignment: Parallel. Purpose: Treatment
• Phase: 3

Countries of recruitment

Cuba

Contacts

• Name: Roselin Valle Cabrera
• Affiliation: National Coordinating Center of Clinical Trials (CENCEC)

• Name: Pedro Camilo Rodriguez
• Affiliation: Center for Molecular Immunology

Key inclusion & exclusion criteria

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)

Age minimum: 18 years
Age maximum: None
Gender: Male/Female

Health Condition(s) or Problem(s) studied

Lung Diseases

Bronchial Neoplasms

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Non small cell lung cancer

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Thoracic Neoplasms

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.

Therapeutic vaccine
CIMAvax-EGF

Primary Outcome(s)

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

Secondary Outcome(s)

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.

Secondary ID(s)

EC151

Source(s) of Monetary Support

Centre for Molecular Immunology Cuban Ministry of Public Health

Secondary Sponsor(s)

Not applicable