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/NCT05555732TROPION-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/NCT05215340STAR-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/NCT05502237AVANZAR: 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
HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy
https://clinicaltrials.gov/study/NCT05338970
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/NCT05048797Beamion 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
TelisoMET (AbbVie): A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared
to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
https://clinicaltrials.gov/ct2/show/NCT04928846?term=m18-868&draw=2&rank=1
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.atDELLphi 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/NCT03924869SKYSCRAPER 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
TREASURE: Thoracic radiotherapy with atezolizumab in small cell lung cancer extensive disease: a randomized, open-label, multicenter phase II study https://www.clinicaltrials.gov/ct2/show/NCT04462276
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/NCT05445843Sotorasib 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/NCT05920356Tropion 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/NCT05215340Tropion 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/NCT05555732GS-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/NCT05502237Mirati 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/NCT04613596MO42720 – 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/NCT05920356Fortitude 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/NCT05325866AMG 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