Interventional phase II clinical trial incorporating a parallel control group of patients receiving no adjuvant immunotherapy. Patients with non small lung cell carcinoma (NSCLC) in stage III A and III B who had no radiochemotherapy before will be enrolled into the phase II clinical trial. The aim of the study is to show the efficacy of an adjuvant treatment with Hsp70-peptide TKD/IL-2 activated, autologous NK cells following completion of standard radiochemotherapy (Cisplatin/Vinorelbine). Med
Conditions
Interventions
Product Name: TKD_NK
Pharmaceutical Form: Solution for infusion
Concentration unit: Other
Concentration type: not less then
Sponsors
Technische Universität München Fakultät für Medizin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. First diagnose of histologically and/or cytologically proven and unresectable NSCLC with clinically stage III A and III B 2. Completion of radiochemotherapy no longer than 8 weeks ago 3. Progression free according to RECIST 1.1 criteria at the first assessment after completion of radiochemotherapy 4. Confirmed presence of Hsp70 on patient´s tumors 5. Female or male, age 18 to 75 years 6. ECOG Status = 2 7. Neutrophil count = 1.5 x 109/l after completion of radiochemotherapy 8. WBC = 2.5 x 109/l after completion of radiochemotherapy 9. Haemoglobin >8g/l after completion of radiochemotherapy 10. Platelet count = 100 x 109/l after completion of radiochemotherapy 11. Normal renal function (creatinine =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Prior treatment with any other investigational drug within 4 weeks prior to first dose of study medication 2. Any severe heart disease or any severe concomitant disease (ECOG stage > 2) 3. NSCLC patients (stage IIIA/B) eligible for initial surgery with a confirmed consent of an interdiscipliary Tumorboard 4. Patients that show ALK positivity or an activating mutation of the EGFR-TK domain 5. Patients with locally advanced or metastastic non-small cell lung cancer other than predominantly squamous cell histology 6. Any disease (including psychotic disorders, drug abuse, active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding likely (in the investigator’s opinion) to affect the evaluation of the study or place the patient at risk whilst on treatment 7. Any serious infection or sepsis 8. Any active autoimmune disease 9. Any immunodeficiency syndrome 10. Surgery or immunotherapy within 4 weeks before study entry 11. Patients with known hypersensitivity to any of the administered substances should be excluded from the clinical trial 12. Patients with a positive HIV test should be excluded from the clinical trial as well as patients with positive Hepatitis A, B, C tests 13. Receipt of immunosuppressive drugs including high dose systemic corticosteroids within 3 weeks before study entry. Low dose corticosteroids as they are a common treatment option for patients suffering from COPD are not an exclusion criterium. 14. Radio-, cytostatic-, and immuno-therapy in parallel or within 4 weeks prior to study start 15. Women who are pregnant or breast feeding 16. Female patients of reproductive potential unwilling to practice a highly effective method of birth control 17. History of noncompliance with medical regimens 18. Patients unwilling to or unable to comply with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to examine whether an adjuvant treatment with TKD/IL-2-activated, patient-derived NK cells following definitive RCT is feasible and effective. Comparison of progression-free survival between treatment and control group A control arm with standard radiochemotherapy (Cisplatin/Vinorelbine) is part of this study, because Pfister et al (2007) could demonstrate that lung cancer patients with an Hsp70 membrane expression had a poorer clinical outcome with respect to overall survival when compared to their Hsp70 membrane counterparts. Therefore, all historic data on overall survival of lung cancer patients are the result of a mixture of Hsp70 positive and negative patients and median overall survival of Hsp70 positive lung cancer patients is not known.;Secondary Objective: To evaluate response to the treatment, toxicity, quality of life (LCSS), increase of overall survival and to determine biological parameters such as NK cell activation. Safety will be assessed according to NCI-CTC criteria.;Primary end point(s): - Progression free survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Response, toxicity, Quality of life (LCSS), Patients overall survival and NK activation | — |
Countries
Germany
Contacts
Public ContactBeate Schossow
Münchner Studienzentrum
Outcome results
None listed