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

Stage IV Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02470468
• Other study ID #: SLU01
• Secondary ID: 2014-003084-37
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 2014
• Est. completion date: November 2021

Study information

• Verified date: May 2022
• Source: SOTIO Biotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: November 2021
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

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)

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Stage IV Non-small Cell Lung Cancer

Intervention

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

Other:
• Standard of Care Chemotherapy
SOC (Carboplatin, Paclitaxel): until progression or intolerance or death

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SOTIO a.s.

Countries where clinical trial is conducted

Czechia,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison of safety in patients treated with DCVAC/LuCa + chemotherapy +/- immune enhancers vs. chemotherapy alone. (AEs, SAEs, laboratory abnormalities, vital signs)		17 months
Secondary	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
Secondary	Further comparison of efficacy of DCVAC/LuCa + chemotherapy +/- immune enhancers vs. chemotherapy alone, as measured by overall survival.		17 months