in Österreich

MARIGOLD: A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer https://clinicaltrials.gov/study/NCT06311721

CEMI-LUNG: An Observational Study to Assess the Effectiveness and Safety of a Cemiplimab in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) in Routine Clinical Practice Settings in Europe (CEMI-LUNG)
https://classic.clinicaltrials.gov/ct2/show/NCT05555732

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.

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

LEPIDOPTERA: Prospective, Multi‐country, Observational Study of Clinical Outcomes in EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Treated with Approved Amivantamab-containing Regimens Under Standard Clinical Practice
https://clinicaltrials.gov/study/NCT07230691

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)

TROPION-Lung10: Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations
https://clinicaltrials.gov/study/NCT06497556

ABBILITY NSCLC-06: Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06)
https://clinicaltrials.gov/study/NCT06635824

KRYSTAL-4: A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)
https://clinicaltrials.gov/study/NCT06875310

TIGOS:A Study to Compare the Efficacy and Safety of BMS-986489 (BMS-986012+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).
https://www.clinicaltrials.gov/study/NCT06646276

CAAA 601A42101:Eine Phase Ib-Dosisfindungsstudie zur Beurteilung der Sicherheit und Aktivität von [177Lu]Lu-DOTA-DATE in Kombination mit Carboplatin, Etoposid und Tislelizumab in der Induktions- und in Kombination mit Tislelizumab in der Erhaltungsphase in neu diagnostizierten kleinzelligen Lungenkarzinomen im fortgeschrittenem Stadium (ES-SCLC).
https://www.lungcancergroup.de/studie/caaa601a42101/

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

ARTEMIDE-Lung02 – D702BC00001: A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination with Platinum-based Chemotherapy for the First-line Treatment of Patients with Metastatic Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1, Astra-Zeneca, PI Hackner,

CA2241093 : A Phase 3, Randomized, Open-label Study of Nivolumab + Relatlimab Fixed-dose Combination with Chemotherapy Versus Pembrolizumab with Chemotherapy as First-line Treatment for Participants with Stage IV or Recurrent Non-squamous Non-small Cell Lung Cancer.  +  PD-L1 > 1 %; BMS;  PI: Hackner

Beamion LUNG-2:  1479-0008: A Phase III, open-label, randomised, active-controlled, multi-centre trial evaluating orally administered BI 1810631 compared to standard of care as first-line treatment in patients with unresectable, locally advanced or metastatic non-squamous non–small cell lung cancer harbouring HER2 tyrosine kinase domain mutations, Boehringer Ingelheim, PI Hackner

KRYSTAL-7: A Phase 2 Trial of Adagrasib Monotherapy and in
Combination with Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination with Pembrolizumab
versus Pembrolizumab in Patients with Advanced Non-
Small Cell Lung Cancer with KRASG12C Mutation,  MIRATI Therapeutics; PI Hackner

TROPION LUNG 10: This Phase III study will investigate the efficacy and safety of Dato-DXd in combination with rilvegostomig as first-line treatment of participants with locally-advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC = 50%) and without actionable genomic alterations (including sensitising EGFR mutations, and ALK and ROS1 rearrangements) using pembrolizumab as a comparator, which is the current SoC in this setting. The population selected for inclusion in this study represents the majority of patients with newly diagnosed locally-advanced or metastatic non-squamous NSCLC, for which a great unmet medical need still exists.

Ansprechpartner: OA Clin.Ass.Prof. DDr. Hackner Klaus, MSc, klaus.hackner@krems.lknoe.at

DeLLphi-312: A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in combination with Durvalumab, Carboplatin and Etoposide versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer , feasibility 11.2.25, PI Handzhiev

IMscin4Real:  A NON-INTERVENTIONAL, MULTICENTER, MULTI- COHORT STUDY TO EVALUATE PATIENTS
REPORTED SATISFACTION, EFFECTIVENESS AND SAFETY OF SUBCUTANEOUS ATEZOLIZUMAB IN PATIENTS TREATED IN ROUTINE CLINICAL PRACTICE, ROCHE, PI Armster;

DeLLphi-305: A Phase 3, Open-label, Multicenter, Randomized Study of Tarlatamab in Combination With Durvalumab vs Durvalumab Alone in Subjects with Extensive-Stage Small-Cell Lung Cancer Following Platinum, Etoposide and Durvalumab (DeLLphi-305)

Ansprechpartner: OA Dr. Handzhiev Sabin, sabin.handzhiev@krems.lknoe.at

FIBRONEER™-On 1305 – 0031: An open-label extension trial of the long-term safety and efficacy of BI 1015550 taken orally in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), Boehringer Ingelheim; PI: Handzhiev

1462-0004: A randomised, double-blind, placebo-controlled, dose-finding
study evaluating efficacy, safety, and tolerability of different oral doses of BI 1819479 over at least 24 weeks in patients with
idiopathic pulmonary fibrosis (IPF), Boehringer Ingelheim, PI: Handzhiev

TroFuse-019 (MK-2870-019): Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR)
https://clinicaltrials.gov/study/NCT06312137

Sunray-02: Study Assessing the Efficacy and Safety of Olomorasib in Combination With Standard of Care Immunotherapy in Participants With Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer
https://clinicaltrials.gov/study/NCT06890598

ABBILITY NSCLC-06:Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer
https://clinicaltrials.gov/study/NCT06635824

RELATIVITY-1093:A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1%
https://clinicaltrials.gov/study/NCT06561386

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-Lung10: Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations
https://clinicaltrials.gov/study/NCT06497556

TroFuse-023 (MK-2870-023): Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
https://clinicaltrials.gov/study/NCT06422143

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

Artemide-02: Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
https://clinicaltrials.gov/study/NCT06692738

LUNAR-2: Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Pembrolizumab and Platinum-based Chemotherapy for the Treatment of Metastatic Non-Small Cell Lung Cancer)
https://clinicaltrials.gov/study/NCT06216301

MK-1084-004: A Study of MK-1084 Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant, Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50%
https://clinicaltrials.gov/study/NCT06345729

SOHO-02: A Study to Learn More About How Well BAY 2927088 Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Human Epidermal Growth Factor Receptor 2 (HER2)
https://clinicaltrials.gov/study/NCT06452277

Telimet-01(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

Keynote-B98: Safety and Efficacy Study of Pembrolizumab (MK-3475) in Combination With Investigational Agents for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy
https://clinicaltrials.gov/study/NCT04938817

TroFuse-019 (MK-2870-019):A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR).
https://clinicaltrials.gov/study/NCT06312137

TROPION-Lung10 (D7632C00001): A Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations.
https://clinicaltrials.gov/study/NCT06357533

TroFuse-023 (MK-2870-023): Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC).
https://clinicaltrials.gov/study/NCT06422143

ABBIL1TY NSCLC-06 (GCT1046-06): Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer.
https://clinicaltrials.gov/study/NCT06635824

TROPION-Lung17 (D763QC00001): A Phase III, Randomised, Open-Label, Multicentre Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations.

KEYNOTE-B98 (MK-3475-B98): Safety and Efficacy Study of Investigational Agents as Monotherapy or in Combination With Pembrolizumab (MK-3475) for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy.
https://clinicaltrials.gov/study/NCT04938817

IDeate-Lung02 (DS7300-188): A Study of Ifinatamab Deruxtecan Versus Treatment of Physician’s Choice in Subjects With Relapsed Small Cell Lung Cancer.
https://clinicaltrials.gov/study/NCT06203210

Telimet-01 (M18-868): 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/study/NCT04928846

ReAlec (MO42122): An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib.
https://clinicaltrials.gov/study/NCT04764188

CodeBreaK 202 (20190341): A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/​C Nonsquamous Non-Small Cell Lung Cancers.
https://clinicaltrials.gov/study/NCT05920356

DESTINY-Lung07 (D7815C00001): A Phase III, Open-label, Randomized, Multicenter, Parallel Arm Study to Evaluate the Efficacy and Safety of 1L Trastuzumab Deruxtecan in Combination With Rilvegostomig or Volrustomig vs Pembrolizumab Plus Chemotherapy in Locally Advanced Unresectable or Metastatic HER2-overexpressing Non-squamous NSCLC.

LALUCA: LALUCA Research Platform A Prospective Analysis of Lung Cancer Diagnosis and Management in Clinical Practice.
https://clinicaltrials.gov/study/NCT04733430

IMscin4Real – MO45893: A Non-Interventional, Multicenter, Multicohort Study to evaluate Patient-reported Satisfaction, Effectiveness and Safety of subcutaneous Atezolizuzmab in Patient Treateed in Routine Clinical Practice

MK-2870-019: A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery
https://clinicaltrials.gov/study/NC06312137

Star-121- GS-US-626-6216 : 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

MK-2870-023: Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
https://clinicaltrials.gov/study/NCT06422143

Marigold – 20210033: A Randomized, Double-Blind Study to Compare Efficacy, Pharmacokinetics, Safety, and Immunogenicity Between ABP 234 and Keytruda® (Pembrolizumab) in Subjects With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer.
https://clinicaltrials.gov/study/NCT06311721

SPLFIO-174: A Phase 1b/2, Multicenter, Open-label Platform Study of Select Immunotherapy Combinations in Adult Participants With Previously Untreated Advanced Non-small Cell Lung Cancer (NSCLC) With High PD-L1 Expression
https://clinicaltrials.gov/study/NCT06162572

MountainTAP-29 – CA240-0029: A Study to Compare the Combination of BMS-986504 With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion (MountainTAP-29)
https://clinicaltrials.gov/study/NCT07063745/

PROCEADE PanTumor – MS202329_0010: Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors
https://clinicaltrials.gov/study/NCT06710132/

Be6A Lung-02 – C5751003: This is a Study to Learn About How the Combination of the Study Medicines Sigvotatug Vedotin Plus Pembrolizumab Works in People With Non-small Cell Lung Cancer With High Levels of PD-L1.
https://clinicaltrials.gov/study/NCT06710132/

SUNRAY-01 – J3M-MC-JZQB: 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

Sunray-02 J3M-MC-JZQH: Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS
G12C-mutant Non-Small Cell Lung Cancer (SUNRAY-02)
https://clinicaltrials.gov/study/NCT06890598/

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/study/NCT04928846

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

AMG 193:A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion.
https://clinicaltrials.gov/study/NCT05975073

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

SOHO-02: A Study to Learn More About How Well BAY 2927088 Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Human Epidermal Growth Factor Receptor 2 (HER2)
https://clinicaltrials.gov/study/NCT06452277

TeliMET (AbbVie)
https://www.abbvieclinicaltrials.com/study/?id=M18-868

LEPIDOPTERA: Prospective, multi‐country, observational study of clinical outcomes in EGFR-mutated, advanced non-small cell lung cancer (NSCLC)  in patients treated with approved amivantamab-containing regimens under standard clinical practice.

Ansprechpartner: OÄ Dr. Katharina Kostenzer, katharina.kostenzer@tirol-kliniken.at