Forschung Thoraxonkologisches… Klinische Studien Molekulare…

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.

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: Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan Compared to Standard of Care in Subjects With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer After Progression on a Third-Generation EGFR TKI
Indikation: NSCLC, Stadium IIIB/ IV, Zweitlinie, EGFR Exon 19del oder L858R
Patienteneinschluss: onhold
EU Trial (CTIS)-Nummer: 2025-521124-29-00

HER-2 Mutation/ Überexpression

Titel: Beamion LUNG-3: A Randomized, Controlled, Multi-center Trial Evaluating Zongertinib as an Adjuvant Monotherapy Compared With Standard of Care in Patients With Early-stage, Resectable Non-small Cell Lung Cancer (Stage II-IIIB) Harboring Tyrosine Kinase Domain Activating HER2 Mutations
Indikation: NSCLC, Stadium II-IIIB, adjuvant; HER2-Mutation
Patienteneinschluss: rekrutierend
EU Trial (CTIS)-Nummer: 2025-521284-12

Titel: A Randomized, Open-label, Multi-center Phase IIa Platform Trial to Evaluate the Safety and Tolerability of Zongertinib Plus Platinum-based Doublet Chemotherapy With or Without Pembrolizumab (and Potential Other Combinations) in Treatment-naïve Patients With Locally Advanced/Metastatic Non-squamous NSCLC With Activating HER2 Mutations
Indikation: NSCLC, Stadium IIIB-IV, Erstlinientherapie, HER2-Mutation 
Patienteneinschluss: rekrutierend
EU Trial (CTIS) - Nummer: 2025-523567-38-00

HLA positiv

Titel: A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific T Cell-Engaging Receptor Molecule (TCER®) Targeting PRAME, as Monotherapy or in Combination With a Checkpoint Inhibitor in Patients With Recurrent and/or Refractory Solid Tumors
Indikation: NSCLC, Stadium IIIB-IV, Erst-bis Drittlinientherapie, sqNSCLC, HLA-2A pos 
Patienteneinschluss: rekrutierend
EU Trial (CTIS)-Nummer: 2022-503133-54-00

Titel: A Randomised, Open-label, Phase 3 Trial Comparing the Efficacy and Safety of OSE2101 Versus Docetaxel in HLA-A2 Positive Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) With Secondary Resistance to Immune Checkpoint Inhibitor
Indikation: NSCLC, Stadium IIIB/ IV, Zweitlinientherapie; HLA-A2 positiv
Patienteneinschluss: rekrutierend
EU Trial (CTIS)-Nummer: 2023-509340-10-00

KRAS/ RAS Mutationen

Titel: A Phase 3, Multicenter, Double-Blind, Placebo-controlled 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 - SUNRAY-02
Indikation: NSCLC, Stadium IB - IIIA, adjuvant, KRAS pG12C Mutation
Patienteneinschluss: rekrutierend
EU Trial (CTIS)-Nummer: 2024-512302-25-00

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: onhold
EU Trial (CTIS)-Nummer: 2023-509571-16

 

Titel: A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Patients With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
Indikation: Adenokarzinom, Stadium IIIB/ IV, Erstlinientherapie KRAS pG12C, PDL1, allcomers 
Patienteneinschluss: rekrutierend
EU Trial (CTIS) - Nummer: 2024-518365-10-00

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: RASolve 301: Phase 3 Multicenter, Open Label, Randomized Study of RMC-6236 Versus Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic RAS[MUT] NSCLC
Indikation: NSCLC, Stadium IIIB/ IV, Zweit- und Drittlinientherapie; H/K/NRAS-Mut. Codons 12, 31 oder 61
Patienteneinschluss: rekrutierend
EU Trial (CTIS)-Nummer: 2024-518154-16

Trop 2 pos

Titel: 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 (TROPION-Lung17)
Indikation: NSCLC ohne AGAs,  Stadium IIIB-IV, Zweit-und Drittlinientherapie, Trop 2 pos.
Patienteneinschluss: rekrutierend
EU Trial (CTIS)-Nummer: 2024-520101-39-00

PD-L1-Expression

Titel: PADL1NK-005: A Randomized, Phase 3, Open-Label Study to Evaluate PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)
Indikation: NSCLC, Stadium III unresectable/ IV, Zweitlinientherapie, PD-L1 positiv
Patienteneinschluss: rekrutierend
EU Trial (CTIS)-Nummer: 2025-521281-97-00

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, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab Monotherapy for the First-line Treatment of Patients With PD-L1-high Metastatic Non-small Cell Lung Cancer (ARTEMIDE-Lung04)
Indikation: NSCLC, Stadium IV, Erstlinientherapie, PD-L1 > 50%
Patienteneinschluss:  rekrutierend
EU Trial (CTIS)-Nummer: 2024-517780-24-00