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)

1st line ES-SCLC

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

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

    SCLC

    Natters Innsbruck Thoracic Oncology Group (NITOG)

    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.

    • MK2870-019: Adjuvant: Pembrolizumab + MK2870 (TROP2-ADC) vs. Pembrolizumab

    NSCLC metastatic

    • TROPION-Lung10: Datopotamab-Deruxtecan (TROP2-ADC) + Rilvegostimig (PD-1 und TIGIT bispecific AK) vs. Rilvegostomig vs. Pemrolizumab
      https://classic.clinicaltrials.gov/ct2/show/NCT06357533

    • LUNAR-2: Phase III Tumor Treating fields (TTF) + Pembrolizumab/Platin-doublet vs.  Pembrolizumab/Platin-doublet
      https://classic.clinicaltrials.gov/ct2/show/NCT06216301

    • LUNAR-4: Phase II Tumor Treating fields (TTF) + Pembrolizumab

    • AMG20230167: Phase Ib/II AMG193 (methylthioadenosine (MTA)- cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor) + Standard of Care

    Metastatic, heavy pretreated

    • BI1456-0001: Phase I BI 1831169 (onkolytischer RNA Virus) + Checkpoint Inhibitor
      https://clinicaltrials.gov/study/NCT05155332

    • PALINDROM: APN401-104 (PBMC basierte Leukozyten Immuntherapie)

    • SOUND: Comprehensive genomic tumour profiling including liquid biopsy