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

  • 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

  • TROPION-Lung07: Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer
    https://clinicaltrials.gov/study/NCT05555732

  • TROPION-Lung08: Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations
    https://clinicaltrials.gov/study/NCT05215340

  • STAR-121: Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer
    https://clinicaltrials.gov/study/NCT05502237

  • AVANZAR: Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab and Carboplatin for First-Line Treatment of Patients With Advanced NSCLC Without Actionable Genomic Alterations
    https://clinicaltrials.gov/study/NCT05687266

EGFR MUTATED

KRAS pG12C mutated

  • SUNRAY-01: A Study of LY3537982 Plus Immunotherapy With or Without Chemotherapy in Participants With Non-Small Cell Lung Cancer (NSCLC) With a Change in a Gene Called KRAS G12C
    https://clinicaltrials.gov/study/NCT06119581

ROS-1 Mutated

  • TRIDENT-3: A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC)
    https://clinicaltrials.gov/study/NCT06140836

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

  • Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment
    https://clinicaltrials.gov/study/NCT06151574

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

  • HLX10-020: A Randomized, Double-Blind, International Multicenter, Phase III Study to Evaluate the Anti-Tumor Efficacy and Safety of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) or Placebo in Combination with Chemotherapy (Carboplatin/Cisplatin-Etoposide) and Concurrent Radiotherapy in Patients with Limited-Stage Small Cell Lung Cancer (LS-SCLC)
    https://clinicaltrials.gov/study/NCT05353257

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 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

  • CODEBREAK 202: Phase 3, First line, Pembro + Platin-Dublette (SoC) versus Sotorasib + Platin-Dublette bei Patienten mit KRAS G12C und PDL-1 <1%
    Ansprechpartner: OA Dr. Hackner Klaus, klaus.hackner@krems.lknoe.at

  • DELLphi 304: AMG 757- Tarlatamab- 20210004 : A Randomized, Open-label, Phase 3 Study of Tarlatamab Compared With Standard of Care in Subjects with Relapsed Small Cell Lung Cancer After Platinum-based First Line Chemotherapy
    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

  • 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.

  • KontRASt-06: An open-label phase II trial evaluating the activity and safety ofJDQ443 single-agent as first-line treatment for patients with locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer with a PDL1 expression < 1% or a PD-L1 expression < 1% and an STK11 co-mutation.
    https://classic.clinicaltrials.gov/ct2/show/NCT05445843

  • Sotorasib AMGEN: A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects with Stage IV or advanced Stage IIIB/C nonsquamous Non–Small Cell Lung Cancers, Negative for PD-L1, and positive for KRAS p.G12C (CodeBreaK 202)
    https://classic.clinicaltrials.gov/ct2/show/NCT05920356

  • Tropion Lung 08: A Randomized, Open-label, Phase 3 Trial of Datopotamab Deruxtecan (Dato-DXd) Plus Pembrolizumab vs Pembrolizumab alone in Treatment-naive Subjects with Advanced or Metastatic PD-L1 High (TPS >50%) Non-small Gell Lung Cancer without actionable genomic Alterations
    https://classic.clinicaltrials.gov/ct2/show/NCT05215340

  • Tropion Lung 07: A Randomized Phase 3 Study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab, with or Without Platinum Chemotherapy, in Subjects with No Prior Therapy for Advanced or Metastatic PD-L1 TPS<50% Non-squamous Non-small Cell Lung Cancer without actionable genomic Alterations (TROPION-LUNG07)”
    https://classic.clinicaltrials.gov/ct2/show/NCT05555732

  • GS-US-626-6216 – Star-121: A Randomized, Open-Label, Phase 3 Study to evaluate Zimberelimab and Domvanalimab in combination with Chemotherapy versus Pembrolizumab with Chemotherapy for the First-Line Treatment of Patients With Metastatic Non–Small Cell Lung Cancer with No epidermal growth factor receptor or anaplastic Lymphoma kinase genomic tumor Aberrations
    https://classic.clinicaltrials.gov/ct2/show/NCT05502237

  • Mirati Krystal7: A Phase 2 Trial of MRTX849 Adagrasib Monotherapy and in Combination with Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination with Pembrolizumab versus Pembrolizumab plus Chemotherapy in Patients with Advanced Non-Small KRAS G12C Mutations
    https://classic.clinicaltrials.gov/ct2/show/NCT04613596

  • MO42720 – Origama: Interventional platform Study investigating the impact of digital health solutions on health outcomes and health-care resource utilization in participants receiving systemic treatment in clinical practice (ORIGAMA)

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)

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

Ansprechpartnerin: Priv.-Doz. OA. Dr. Gudrun Absenger, gudrun.absenger@medunigraz.at

NSCLC metastatic

  • Codebreak 202:  A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non–Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)
    https://clinicaltrials.gov/study/NCT05920356

  • Fortitude 301: A Phase 1b/2, Multicenter, Open-label Basket Study Evaluating the Safety and Efficacy of Bemarituzumab Monotherapy in Solid Tumors with FGFR2b Overexpression (FORTITUDE-301)
    https://clinicaltrials.gov/study/NCT05325866

  • AMG 193 MTAP: A phase 1/1b/2 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AMG 193 alone and in combination with docetaxel in subjects with advanced MTAP-null solid tumors
    https://clinicaltrials.gov/study/NCT05975073