Predictor of response with CIMAvax EGF© in NSCLC Phase III

Phase 3

Recruiting

• Conditions: Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Bronchial Neoplasms; on small cell lung cancer; Carcinoma, Bronchogenic; Lung Diseases; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Diseases

• Registration Number: RPCEC00000208
• Lead Sponsor: Centre for Molecular Immunology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Anti-EGF antibodies titers (serum dilutions). Measuring time: At baseline, quaterly during 4 first immunizations and then monthly in every immunization. <br>Serum EGF concentration (pg/mL). Measuring time: At baseline, at month six and at month 12. <br>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.<br>