Targeted Natural Killer (NK) cell based adoptive immunotherapy for the treatment of patients with Non-Small Cell Lung Cancer (NSCLC) after radiochemotherapy (RCT)

Phase 1

Conditions: 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).
MedDRA version: 19.1Level: LLTClassification code 10006427Term: Bronchial carcinoma stage IIISystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2008-002130-30-DE

Lead Sponsor: Technische Universität München Fakultät für Medizin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 90

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 <150% ULN)
12.Normal liver function (Bilirubin <200% ULN; G-GT, GPT und GOT <250% ULN;)
13.Normal blood coagulation (PTT 25-40s)
14.Measurable disease according to irRC criteria
15.Female patients of childbearing potential must have negative pregnancy test performed during screening period (= 14 days before initiation of study drug dosing). Postmenopausal women must be amenorrheal for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective method of birth control throughout the study and for 6 months following discontinuation of study drug.
16.Written (signed) Informed Consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment and to participate in the study
17.Ability to comply with study and follow-up procedures

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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