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

Phase 1

Completed

• Conditions: Stage IV Non-small Cell Lung Cancer
• Interventions: Biological: DCVAC and immune enhancers add on to SOC; Other: Standard of Care Chemotherapy; Biological: DCVAC add on to SOC

• Registration Number: NCT02470468
• Lead Sponsor: SOTIO a.s.

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).

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 Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-06-09
• Study First Posted: 2015-06-12
• Primary Completion: 2018-01
• Study Completion: 2021-11
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

1. 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.

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 (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)

6. 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.

7. 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

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. Participation in a clinical trial using experimental therapy within the last 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
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DCVAC and immune enhancers add on to SOC	DCVAC and immune enhancers add on to SOC	Combination therapy with DCVAC, immune enhancers (Interferon-α, Hydroxychloroquine) and Standard of Care (Carboplatin, Paclitaxel)
Standard of Care Chemotherapy	Standard of Care Chemotherapy	Standard of Care chemotherapy (Carboplatin, Paclitaxel)
DCVAC add on to SOC	DCVAC add on to SOC	Combination therapy with DCVAC and Standard of Care (Carboplatin, Paclitaxel)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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