Stage IV Non-Small Cell Lung Cancer MedDRA version: 20.1 Level: PT Classification code 10025070 Term: Lung carcinoma cell type unspecified stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: DCVAC/LuCa
Product Code: DCVAC/LuCa
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: DCVAC/LuCa
Other descriptive name: CELL SUSPENSION CONTAINING DENDRITIC CELLS
Conce
Sponsors
SOTIO a.s.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of either adenomatous, squamous or large cell carcinoma differentiation; mixed tumors will be categorized by the predominant cell type. 2 Advanced NSCLC (stage IV unresectable disease) 3 Patients must have measurable or non-measurable disease 4 Patients (male and female) = 18 years 5 Eastern Cooperative Oncology Group (ECOG) Performance status 0-1 6 Patients must have recovered from toxicity of any prior therapy (e.g. surgery, radiotherapy, or therapy for other diseases than NSCLC). Recovery is defined as less than or equal to grade 2 toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (except alopecia 7 Laboratory criteria 7.1 Platelet count of at least 100,000/mm3 (100 x 109/L) 7.2 White blood cells (WBC) greater than 4,000/mm3 (4.0 x109/L) 7.3 Hemoglobin (Hb) at least 9g/dL (90 g/L) 7.4 Total bilirubin levels =1.5mg/dL (benign hereditary hyperbilirubinemias, e.g., Gilbert´s syndrome are permitted) 7.5 Serum alanine aminotransferase and aspartate aminotransferase = 5 times the upper limit of normal (ULN) 7.6 Serum creatinine = 1.5 times the upper limit of normal (ULN) 8 Women of childbearing potential and sexually active males must agree to use an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to study entry and for the duration of the treatment plus 3 months. 9 Signed informed consent including patient’s ability to comprehend its contents. (Consent to genetic testing is not a condition for participation in the clinical trial) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 85
Exclusion criteria
Exclusion criteria: 1 Prior chemotherapy for stage IV NSCLC 2 Immunotherapy, monoclonal antibodies received within 4 weeks prior to randomization 3 Patients comorbidities 3.1 Patients who are not indicated for chemotherapy treatment with first line Standard of Care chemotherapy (carboplatin/paclitaxel) 3.2 Active other malignancy than NSCLC 3.3 Known central nervous system (CNS) metastases 3.4 Any disease requiring chronic steroid or immunosuppressive therapy 3.5 HIV positive 3.6 Active hepatitis B (HBV) and/or C (HCV), active syphilis 3.7 Ongoing/active significant infection or other severe medical condition 3.8 Pre-existing thyroid disease unless it can be controlled with conventional treatment 3.9 Clinically significant cardiovascular disease including: 3.9.1 Uncontrolled congestive heart failure 3.9.2 Unstable angina pectoris 3.9.3 Uncontrolled severe cardiac arrhythmia 3.9.4 Myocardial infarction within 6 months prior randomization 3.10 Psychiatric illness/social situations that would limit compliance with study requirements 4 Pregnant or breast feeding women 5 Use of any experimental therapy within 4 weeks prior to randomization 6 Contra indications to treatment with hydroxychloroquine, known G6PD deficiency (anamnestic information, no test necessary) and psoriasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare efficacy of DCVAC/LuCa + chemotherapy without immune enhancers vs. chemotherapy alone in patients with stage IV NSCLC, as measured by overall survival (OS).;Secondary Objective: • Comparison of PFS in patients treated with DCVAC/LuCa + chemotherapy without immune enhancers vs. chemotherapy alone. • Comparison of safety in patients treated with DCVAC/LuCa + chemotherapy without immune enhancers vs. chemotherapy alone. • Further comparison of efficacy of DCVAC/LuCa + chemotherapy without immune enhancers vs. chemotherapy alone, as measured by objective response rate (ORR) and duration of response (per RECIST 1.1) ;Primary end point(s): OS defined as the time from the date of randomization to the date of death due to any cause. ;Timepoint(s) of evaluation of this end point: The primary efficacy analysis will be performed approximately 12 months after the last patient randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PFS Safety parameters as AEs, SAEs, laboratory abnormalities, vital signs ORR and duration of response (per RECIST 1.1) ;Timepoint(s) of evaluation of this end point: The primary efficacy analysis will be performed approximately 12 months after the last patient randomization. | — |
Countries
Czech Republic, Slovakia
Contacts
Public ContactClinical Trials SOTIO
SOTIO a.s.
Outcome results
None listed