Aktuelle onkologische Studien

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

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

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

SCLC

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

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

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

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

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

SCLC

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

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 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

SCLC

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

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

SCLC

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 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.

EGFR mutated
Parexel# 247131 AZ COMPEL: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Platinum Plus Pemetrexed Chemotherapy Plus Osimertinib Versus Plantinum Plus Pemetrexed Chemotherapy Plus Placebo in Patients with EGFRm, Locally Advanced or Metastatic NSCLC who have Progressed Extracranially follwing First-Line Osimertinib Therapy (COMPEL)

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-
Authorisation Safety Study

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)

Retrospektive Datenauswertung
Thassos – AZ NSCLC: Real-World Data Study of early-Stage (I, II, III) NSCLC

SCLC

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

AMG 757 (TARLATAMAB) – A Bite molecule+: A Phase 1b Study Evaluating the Safety and Efficacy of AMG 757 in Combination With AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)
https://www.clinicaltrials.gov/ct2/show/NCT04885998

 

Innsbruck Thoracic Oncology Group

Ansprechpartner: OA Dr. Georg Pall, georg.pall@tirol-kliniken.at

AEGEAN:  A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Stages II and III Non-small Cell Lung Cancer
https://www.clinicaltrials.gov/ct2/show/NCT03800134

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

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

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

AMG 757/AMG 404: A Phase 1b Study Evaluating the Safety and Efficacy of AMG 757 in Combination With AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)
https://www.clinicaltrials.gov/ct2/show/NCT04885998