Evaluation of Safety and Efficacy of DCVAC/LuCa (Immunotherapy of Lung Cancer) in Patients With Metastatic Lung Cancer

Sponsor

SOTIO a.s. (Industry)

Overall Status

Completed

CT.gov ID

NCT02470468

Collaborator

(none)

105

Enrollment

Locations

Arms

Actual Duration (Months)

5.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to compare efficacy of DCVAC/LuCa + chemotherapy +/- immune enhancers vs. chemotherapy alone in patients with stage IV NSCLC, as measured by progression free survival (PFS).

Condition or Disease	Intervention/Treatment	Phase
Stage IV Non-small Cell Lung Cancer	Biological: DCVAC add on to SOC Biological: DCVAC and immune enhancers add on to SOC Other: Standard of Care Chemotherapy	Phase 1/Phase 2

Detailed Description

The purpose of the study is to compare efficacy of DCVAC/LuCa + chemotherapy +/- immune enhancers vs. Standard of Care chemotherapy alone in patients with stage IV NSCLC, as measured by progression free survival (PFS).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I/II Study to Evaluate Safety and Efficacy of DCVAC/LuCa Added to Standard First Line ChT With Carboplatin and Paclitaxel +/- Immune Enhancers (Interferon-α and Hydroxychloroquine) vs ChT Alone in Patients With Stage IV NSCLC

Actual Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

Jan 1, 2018

Actual Study Completion Date :

Nov 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DCVAC add on to SOC Combination therapy with DCVAC and Standard of Care (Carboplatin, Paclitaxel)	Biological: DCVAC add on to SOC DCVAC add on to SOC (Carboplatin, Paclitaxel): until progression or intolerance or death
Experimental: DCVAC and immune enhancers add on to SOC Combination therapy with DCVAC, immune enhancers (Interferon-α, Hydroxychloroquine) and Standard of Care (Carboplatin, Paclitaxel)	Biological: DCVAC and immune enhancers add on to SOC DCVAC +/- immune enhancers (Interferon-α and Hydroxychloroquine) add on to SOC (Carboplatin, Paclitaxel): until progression or intolerance or death
Other: Standard of Care Chemotherapy Standard of Care chemotherapy (Carboplatin, Paclitaxel)	Other: Standard of Care Chemotherapy SOC (Carboplatin, Paclitaxel): until progression or intolerance or death

Arm

Intervention/Treatment

Experimental: DCVAC add on to SOC

Combination therapy with DCVAC and Standard of Care (Carboplatin, Paclitaxel)

Biological: DCVAC add on to SOC

DCVAC add on to SOC (Carboplatin, Paclitaxel): until progression or intolerance or death

Experimental: DCVAC and immune enhancers add on to SOC

Combination therapy with DCVAC, immune enhancers (Interferon-α, Hydroxychloroquine) and Standard of Care (Carboplatin, Paclitaxel)

Biological: DCVAC and immune enhancers add on to SOC

DCVAC +/- immune enhancers (Interferon-α and Hydroxychloroquine) add on to SOC (Carboplatin, Paclitaxel): until progression or intolerance or death

Other: Standard of Care Chemotherapy

Standard of Care chemotherapy (Carboplatin, Paclitaxel)

Other: Standard of Care Chemotherapy

SOC (Carboplatin, Paclitaxel): until progression or intolerance or death

Outcome Measures

Primary Outcome Measures

Comparison efficacy of DCVAC/LuCa + chemotherapy +/- immune enhancers vs. chemotherapy alone in patients with stage IV NSCLC, as measured by progression free survival (PFS). [17 months]

Secondary Outcome Measures

Comparison of safety in patients treated with DCVAC/LuCa + chemotherapy +/- immune enhancers vs. chemotherapy alone. (AEs, SAEs, laboratory abnormalities, vital signs) [17 months]
Further comparison of efficacy of DCVAC/LuCa + chemotherapy +/- immune enhancers vs. chemotherapy alone, as measured by objective response rate and duration of response (per RECIST 1.1). [17 months]
Further comparison of efficacy of DCVAC/LuCa + chemotherapy +/- immune enhancers vs. chemotherapy alone, as measured by overall survival. [17 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of either adenomatous or squamous cell carcinoma differentiation; mixed tumors will be categorized by the predominant cell type.
Advanced NSCLC (stage IV unresectable disease)
Patients must have measurable or non-measurable disease
Patients (male and female) ≥ 18 years
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 (except alopecia) to NCI CTCAE 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 hyper-bilirubinemias, 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)
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.
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)

Exclusion Criteria:

Prior chemotherapy for stage IV NSCLC
Immunotherapy, monoclonal antibodies received within 4 weeks prior to randomization
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
Pregnant or breast feeding women
Participation in a clinical trial using experimental therapy within the last 4 weeks prior to randomization
Contra indications to treatment with hydroxychloroquine, known G6PD deficiency (anamnestic information, no test necessary) and psoriasis

Contacts and Locations

Locations

	City	Country	Postal Code
1	Brno	Czechia	625 00
2	Hradec Kralove	Czechia	500 05
3	Jindřichův Hradec	Czechia	377 38
4	Kutna Hora	Czechia	284 01
5	Nachod	Czechia	547 69
6	Olomouc	Czechia	775 20
7	Ostrava	Czechia	708 52
8	Pardubice	Czechia	530 03
9	Plzen	Czechia	305 99
10	Praha	Czechia	128 08
11	Praha	Czechia	140 59
12	Praha	Czechia	150 06
13	Pribram	Czechia	261 95
14	Usti nad Labem	Czechia	401 13
15	Zlin	Czechia	762 75
16	Kosice	Slovakia	040 01
17	Piest'any	Slovakia	921 01
18	Poprad	Slovakia	058 01