Forschung Thoraxonkologisches… Klinische Studien Molekulare…
Thoraxonkologisches Studienzentrum

Molekulare Alteration

Bei der Erkrankung Nichtkleinzelliges Lungenkarzinom mit vorhandener molekularer Alteration wird im Rahmen von Arzneimittelstudien untersucht, ob die Prüfmedikamente einen positiven Einschluss auf den Erkrankungsverlauf haben. Bitte haben Sie Verständnis dafür, dass manche Studieninformationen nur in englischer Sprache aufgeführt sind. Wenn wir Ihr Interesse geweckt haben, finden Sie nachfolgend Details zu unseren Arzneimittelstudien bei Nichtkleinzelligem Lungenkarzinom mit vorhandener molekularer Alteration.

div. molekulare Alterationen

TTF-1 neg, ALK pos, EGFR neg, PD-L1 < 50%

Titel: Atezolizumab/Carboplatin/Nab-Paclitaxel vs. Pembrolizumab/Platinum/Pemetrexed in Metastatic TTF-1 Negative Lung Adenocarcinoma
Indikation: NSCLC, Stadium IV, Erstlinientherapie; TTF-1 neg, ALK pos, EGFR neg, PD-L1 < 50%
Patienteneinschluss: rekrutierend
EudraCT-Nummer: 2022-002990-27

ALK-Testung positiv

Titel: A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients With Advanced NSCLC and Other Solid Tumors (ALKOVE-1)
Indikation: NSCLC, Stadium IIIB/IV, ab Erstlinientherapie , ALK positiv
Patienteneinschluss: rekrutierend
EudraCT-Nummer: 2022-000122-21

 

c-Met positiv

Titel: A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer
Indikation: NSCLC, Stadium IIIb-IIIc/IV, c-Met positiv,  Zweit- bis Viertlinientherapie
Patienteneinschluss: rekrutierend
EudraCT-Nummer: 2021-001811-94/ 2023-505749-14-00

EGFR Exon 19

Titel: Preoperative Amivantamab or Amivantamab and Carboplatin/pemetrexed Treatment in Patients with Resectable Non-small-cell Lung Cancer Harboring Oncogenic EGFR Mutations (NEOpredict-EGFR)
Indikation: NSCLC, Stadium IB - IIIA, neoadjuvant, EGFR Ex19Del und/ oder L858R
Patienteneinschluss: rekrutierend
EU Trail (CTIS)-Nummer: 2023-505662-28-00

Titel: Additional Chemotherapy for EGFRm Patients With the Continued Presence of Plasma ctDNA EGFRm at Week 3 After Start of Osimertinib 1st-line Treatment (PACE-LUNG)
Indikation: NSCLC, Stadium IIIB/IV, Erstlinientherapie, EGFR Exon 19del oder L858R
Patienteneinschluss: rekrutierend
EudraCT-Nummer: 2019-004757-88

Titel: A Phase 2, Open-Label, Randomized Trial Evaluating the Impact of Enhanced Versus Standard Dermatologic Management on Selected Dermatologic Adverse Events Among Patients With Locally Advanced or Metastatic EGFR-Mutated NSCLC Treated First-Line With Amivantamab + Lazertinib
Indikation: NSCLC, Stadium IIIB/IV, Erstlinientherapie, EGFR Exon 19del oder L858R
Patienteneinschluss: onhold
EudraCT-Nummer: 2023-505863-35-00

HER-2 Mutation/ Überexpression

Titel: Beamion LUNG 2: A Phase III, Open-label, Randomized, Active-controlled, Multi-centre Trial Evaluating Orally Administered Zongertinib (BI 1810631) Compared With 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
Indikation: NSCLC, Stadium III unresectable/ IV, Erstlinientherapie; HER 2 Exon 19 oder 20
Patienteneinschluss: onhold
EudraCT-Nummer: 2023-504308-27-00

HLA positiv

Titel: A Phase Ia/Ib First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Initial Anti-Tumor Activity of IMA401, a Bispecific T Cell Engaging Receptor Molecule (TCER®), as Monotherapy or in Combination With Checkpoint Inhibitor in Patients With Recurrent and/or Refractory Solid Tumors.
Indikation: solide Tumore, Stadium IIIB/ IV, Erst- bis Fünftlinientherapie, HLA pos. 
Patienteneinschluss: rekrutierend
EU Trial (CTIS)-Nummer: 2023-506854-19-00

KRAS/ RAS Mutationen

Titel: A Platform Study of RAS(ON) Inhibitor Combinations in Patients with RAS-Mutated Non-Small Cell Lung Cancer (NSCLC)
Indikation: NSCLC advanced/ metastatic, Erstlinientherapie; Subprotocol A: KRAS G12C Mutation - Subprotocol B: RAS Mutation
Patienteneinschluss: rekrutierend
EudraCT-Nummer: 2023-509571-16

 

Titel: SUNRAY-01, A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum Regardless of PD-L1 Expression
Indikation: NSCLC, Stadium IIIB/IV, Erstlinientherapie, KRAS G12C + PD-L1 > 50% 
Patienteneinschluss: rekrutierend
EU Trial (CTIS)-Nummer: 2023-503412-33-00

Titel: A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Patients With Previously Treated KRAS G12C-Positive Advanced or Metastatic Non-Small Cell Lung Cancer
Indikation: NSCLC, Stadium IIIB/ IV, Zweit- bis Viertlinientherapie; KRAS pG12C Mutation
Patienteneinschluss: rekrutierend
EudraCT-Nummer: 2024-510908-37-00

MTAP deletion

Titel: 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 (Master Protocol)
Indikation: NSCLC/ Thorakale Tumore, Stadium IIIB/ IV, Erstlinientherapie, MTAP-deletion 
Patienteneinschluss: rekrutierend
EU Trial (CTIS)-Nummer: 2024-511253-21

PD-L1-Expression

Titel: 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 (ARTEMIDE-Lung02)
Indikation: NSCLC (squamous), Stadium IIIB-IIIC/IV, Erstlienientherapie, Squamous, PDL1 pos 
Patienteneinschluss: rekrutierend
EU Trial (CTIS)-Nummer: 2024-514281-39-00

Titel: A Phase III, Randomised, Open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Pembrolizumab Monotherapy for the 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 (TROPION-Lung10)
Indikation: NSCLC, Stadium IIIB-IIIC/IV, Erstlinientherapie, PDL1 > 50% 
Patienteneinschluss: rekrutierend
EU Trial (CTIS)-Nummer: 2023-505077-32-00

Titel: A Phase III, Two-Arm, Parallel, Randomized, Multi-Center, Open-Label, Global Study to Determine the Efficacy of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer (mNSCLC).
Indikation: NSCLC, Stadium IV, Erstlinientherapie, PD-L1 TC expression < 50% 
Patienteneinschluss: rekrutierend
EudraCT-Nummer: 2023-503298-39-00

Thoraxonkologisches Studienzentrum