Evaluation of safety and efficacy of DCVAC/LuCa (immunotherapy of lung cancer) in patients with metastatic lung cancer

Phase 1

Conditions: Stage IV Non-Small Cell Lung Cancer
MedDRA version: 20.1Level: PTClassification code 10025070Term: Lung carcinoma cell type unspecified stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2014-003084-37-CZ

Lead Sponsor: SOTIO a.s.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 98

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>•Comparison of safety in patients treated with DCVAC/LuCa + chemotherapy without immune enhancers vs. chemotherapy alone.<br>•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)<br>;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 Outcome Measures

Name	Time	Method
Secondary end point(s): PFS<br>Safety parameters as AEs, SAEs, laboratory abnormalities, vital<br>signs<br>ORR and duration of response (per RECIST 1.1)<br>;Timepoint(s) of evaluation of this end point: The primary efficacy analysis will be performed approximately 12 months after the last patient randomization.

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