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JOURNAL ONKOLOGIE – STUDIE

Targeted Natural Killer (NK) Cell Based Adoptive Immunotherapy for the Treatment of Patients With Non-Small Cell Lung Cancer (NSCLC) After Radiochemotherapy (RCT)

Schwebend

NCT-Nummer:
NCT02118415

Studienbeginn:
März 2014

Letztes Update:
15.01.2019

Wirkstoff:
-

Indikation (Clinical Trials):
Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Technische Universität München, Technische Universität München

Collaborator:
-

Studienleiter

Hanno Specht, Dr.
Principal Investigator
Klinikum rechts der Isar, TU München

Studienlocations
(1 von 1)

Klinikum rechts der Isar, Strahlentherapie und Radiologische Onkologie
81675 Munich
(Bayern)
Germany» Google-Maps

Studien-Informationen

Detailed Description:

Patients with non-small cell lung carcinoma (NSCLC) in stage III A and III B showing at least stable disease after RCTx will be enrolled into the 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). Patients will be randomized 1:1 either to the interventional study group to receive 4 cycles of autologous immunotherapy with activated NK cells or to the control group (BSC).
 

Ein-/Ausschlusskriterien

Inclusion Criteria:

- First diagnosis of histologically and/or cytologically proven and unresectable NSCLC with clinically stage III A and III B

- Completion of radiochemotherapy no longer than 8 weeks ago

- Progression free according to RECIST criteria at the first assessment after completion of RCTx

- Confirmed presence of Hsp70 on patient´s tumors

- ECOG Status(Appendices) ≤ 2

Exclusion Criteria:

- Any severe heart disease or any severe concomitant disease (ECOG stage > 2)

- NSCLC patients (stage IIIA/B) eligible for initial surgery with a confirmed consent of an interdisciplinary tumorboard

- Patients that show ALK positivity or an activating mutation of the EGFR-TK domain

- Patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology

- 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

Studien-Rationale

Primary outcome:

1. Progress free survival (Time Frame - follow up after randomization for at least 18 months)



Secondary outcome:

1. overall survival (OS) (Time Frame - follow up after randomization for at least 18 months)

2. toxicity (AE and SAE) (Time Frame - follow up after randomization for at least 18 months)

3. quality of life (QoLQ-30, LC-13) (Time Frame - follow up after randomization for at least 18 months)

4. biological parameters (NK cell activation) (Time Frame - follow up after randomization for at least 18 months)

Studien-Arme

  • Experimental: Interventional
    Interventional group: activated autologous NK cell treatment
  • No Intervention: Control group
    Control group: BSC

Geprüfte Regime

  • Hsp70-peptide TKD/IL-2 activated, autologous NK cells:
    Adjuvant treatment with Hsp70-peptide TKD/IL-2 activated, autologous NK cells following completion of standard radiochemotherapy (Cisplatin/Vinorelbine)

Quelle: ClinicalTrials.gov


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