EUCTR2014-003084-37-SK
Active, not recruiting
Phase 1
A phase I/II study to evaluate safety and efficacy of DCVAC/LuCa added to standard first line chemotherapy with carboplatin and paclitaxel +/- immune enhancers (interferon-a and hydroxychloroquine) vs chemotherapy alone in patients with Stage IV non-small cell lung cancer
SOTIO a.s.0 sites98 target enrollmentJanuary 8, 2015
ConditionsStage IV Non-Small Cell Lung CancerMedDRA version: 21.1Level: 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]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Stage IV Non-Small Cell Lung Cancer
- Sponsor
- SOTIO a.s.
- Enrollment
- 98
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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)
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
Outcomes
Primary Outcomes
Not specified
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