Aktuelle onkologische Studien

in Österreich, Stand 1.2.2023

Klinik Floridsdorf, Abteilung für Innere Medizin und Pneumologie (Wien)

Studienkoordinator: Christoph Weinlinger, BSc, MSc christoph.weinlinger@extern.gesundheitsverbund.at
Studienarzt: Dr. Maximilian Hochmair maximilian.hochmair@gesundheitsverbund.at

NSCLC early stage

  • NeoADAURA: A Phase III, Randomised, Controlled, Multi-center, 3-Arm Study of Neoadjuvant Osimertinib as Monotherapy or in Combination With Chemotherapy Versus Standard of Care Chemotherapy Alone for the Treatment of Patients With Epidermal Growth Factor Receptor Mutation Positive, Resectable Non-small Cell Lung Cancer
    https://clinicaltrials.gov/ct2/show/NCT04351555

  • LIBRETTO-432: A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib Following Definitive Locoregional Treatment in Participants With Stage IB-IIIA RET Fusion-Positive NSCLC
    https://www.clinicaltrials.gov/ct2/show/NCT04819100

NSCLC metastatic

  • HUDSON: An Open-Label, Multi-Drug, Biomarker-Directed, Multi-Centre Phase II Umbrella Study in Patients With Non-Small Cell Lung Cancer, Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy
    https://clinicaltrials.gov/ct2/show/NCT03334617

  • Evoke-01: Open-Label, Global, Multicenter, Randomized, Phase 3 Study of Sacituzumab Govitecan Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy
    https://clinicaltrials.gov/ct2/show/NCT05089734

  • KEYVIBE-007: A Randomized, Double-Blind, Phase 3 Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination with Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants with Metastatic Non-Small Cell Lung Cancer
    https://clinicaltrials.gov/ct2/show/NCT05226598

EGFR Exon 20 Insertion

  • Exclaim-2: A Randomized Phase 3 Multicenter Open-label Study to Compare the Efficacy of TAK-788 as First-line Treatment Versus Platinum-Based Chemotherapy in Patients With Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations
    https://www.clinicaltrials.gov/ct2/show/NCT04129502

KRAS pG12C mutated

HER2 Exon 19 or 20 Mutation

  • DESTINY-Lung04: An Open-label, Randomized, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Trastuzumab Deruxtecan as First-line Treatment of Unresectable, Locally Advanced, or Metastatic NSCLC Harboring HER2 Exon 19 or 20 Mutations
    https://clinicaltrials.gov/ct2/show/NCT05048797

cMET Overexpression

  • M18-868: A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects with Previously Treated c-Met+, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer
    https://clinicaltrials.gov/ct2/show/NCT04928846

1st line ES-SCLC

  • KEYNOTE-B99: A Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Investigational Agents in Combination With Etoposide and Cisplatin or Carboplatin for the First-Line Treatment of Participants With Extensive-Stage Small Cell Lung Cancer https://clinicaltrials.gov/ct2/show/NCT04924101

SCLC ES

  • KEYVIBE-008: A Phase 3, Randomized, Double-Blind Study of MK-7684A in Combination with Etoposide and Platinum Followed by MK-7684A vs Atezolizumab in Combination with Etoposide and Platinum Followed by Atezolizumab for the First-Line Treatment of Participants with Extensive-Stage Small Cell Lung Cancer
    https://clinicaltrials.gov/ct2/show/NCT05224141

SCLC relapsed, refractory

  • KEYNOTE-B98: A Phase 1b/2 Study to Evaluate the Efficacy and Safety of Pembrolizumab in Combination With Investigational Agents for the Treatment of Participants With PD-1/L1-refractory Extensive-Stage Small Cell Lung Cancer in Need of Second-Line Therapy
    https://clinicaltrials.gov/ct2/show/NCT04938817

Klinik Penzing, Abteilung für Atemwegs- und Lungenkrankheiten (Wien)

Studienkoordinatorin: Mag. Alexa Kahraman alexa.kahraman@oncolbilh.com
Studienarzt: Dr. Florian Huemer florian.huemer@gesundheitsverbund.at

NSCLC early stage

  • KEYNOTE-867: A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Participants With Unresected Stages I or II Non Small Cell Lung Cancer (NSCLC)
    https://clinicaltrials.gov/ct2/show/NCT03924869

NSCLC metastatic

Klinik Ottakring, 2.Medizinische Abteilung mit Pneumologie, Karl Landsteiner Institut für Lungenforschung und Pneumologische Onkologie

Ansprechpartner: OA Dr. Klaus Kirchbacher klaus.kirchbacher@gesundheitsverbund.at

  • Landsteiner Lung Cancer Research Platform (LALUCA) – A prospective analysis of Lung Cancer Diagnosis and Management in Clinical Practice
    Patientenpopulation: alle Patientinnen und Patientin mit Lungenkrebs
    Zeitrahmen: seit 2020, open end

Universitätsklinikum Krems, Abteilung für Pneumologie

NSCLC early stage

  • SKYSCRAPER 03: A Phase III, Open-Label, Randomized Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Patients With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer Who Have Not Progressed After Concurrent Platinum-Based Chemoradiation
    Start: Mai 2021
    Ansprechpartner: OA Dr. Sabin Handzhiev, sabin.handzhiev@krems.lknoe.at

1st line ES-SCLC

  • SPACE: Single-Arm Phase II-Study in Patients with extensive stage small-cell lung cancer (ES-SCLC) with Poor Performance Status receiving Atezolizumab-Carboplatin-Etoposide
    Start: Okt. 2020
    Ansprechpartner: OA Dr. Klaus Hackner, klaus.hackner@krems.lknoe.at

SCLC relapsed, refractory

  • AMG 757 (DeLphi-301): A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 757
    in Subjects with Relapsed/Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment
    Start: Feb. 2022
    Ansprechpartner: OA Dr. Sabin Handzhiev, sabin.handzhiev@krems.lknoe.at

Kepler Universitätsklinikum, Universitätsklinik für Innere Medizin 4 – Pneumologie

Ansprechpartnerin: OÄ Dr. Romana Wass, PhD romana.wass@kepleruniklinikum.at

NSCLC early stage

  • KEYNOTE-867: A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Participants With Unresected Stages I or II Non Small Cell Lung Cancer (NSCLC)
    https://clinicaltrials.gov/ct2/show/NCT03924869

  • SKYSCRAPER 03: A Phase III, Open-Label, Randomized Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Patients With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer Who Have Not Progressed After Concurrent Platinum-Based Chemoradiation
    https://clinicaltrials.gov/ct2/show/NCT04513925

1st line ES-SCLC

Klinikum Klagenfurt, Abteilung für Lungenkrankheiten

Ansprechpartner: Prim. Dr. Markus Rauter, Markus.Rauter@kabeg.at

NSCLC early stage

  • Canopy A: A phase III, multicenter, randomized, double blind, placebo-controlled study evaluating the efficacy and
    safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC)

NSCLC metastatic

  • NIVO PASS: Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice

  • ImReal MO40653: A non-interventional, multi-centre, multiple cohort study to investigate the outcomes and safety of atezolizumab under real-life conditions in patients treated in routine clinical practice.

ALK positive

  • Brigatinib 5007 – PASS: A Cohort Study to Describe the Occurrence of Early-Onset Pulmonary Events in Patients with Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Treated with Brigatinib: A Post-

  • MO42122 ReAlec: A multicenter noninterventional cohort study to evaluate the real world clinical managements and outcomes of patients diagnosed with ALK positive advanced NSCLC treated with Alectinib (Realec)

1st line ES-SCLC

  • AIO-TRK-0119-SPACE: Single-Arm Phase II-Study in Patients with extensive stage small-cell lung cancer (ES-SCLC) with Poor Performance Status receiving Atezolizumab-Carboplatin-Etoposide (SPACE)

Medizinische Universität Graz, Klinische Abteilung für Onkologie, in Zusammenarbeit mit LKH Hochsteiermark

Ansprechpartnerin: Priv.-Doz. Dr. Angelika Terbuch,  angelika.terbuch@medunigraz.at

SCLC

Innsbruck Thoracic Oncology Group

Ansprechpartner: Priv.-Doz. Dr. Andreas Pircher, andreas.pircher@i-med.ac.at

NSCLC early stage

  • INN-WOP1, Phase II:  Neoadjuvante Window-Of-Opportunity-Studie zur Kurzzeittherapie mit Pembrolizumab/Lenvatinib vor OP eines NSCLC in frühen Stadien. Postoperativ Pembrolizumab für 1 Jahr. Akademische, monozentrische Studie. Nach erfolgtem Amendment können Patient*innen sowohl vor als auch nach erfolgter histologischer Diagnosesicherung eingeschlossen werden.

  • Keynote 867: A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Participants With Unresected Stages I or II Non Small Cell Lung Cancer (NSCLC)
    https://clinicaltrials.gov/ct2/show/NCT03924869

NSCLC metastatic

  • Keyvibe, Phase III: Metast. NSCLC, First-Line-Therapie; Randomisierung zwischen CTX + Pembrolizumab vs. CTX + Pembrolizumab + Vibostolimab (Anti-TIGIT-Antikörper)

HER2 Exon 19 or 20 Mutation

  • Destiny Lung 04: First Line Therapie mestast. NSCLC, Her2-mutiert. Randomisierung zwischen CTX+ Immuntherapie vs. Trastuzumab-Deruxtecan