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Brief Title: Pemetrexed-free vs. Pemetrexed-based Immunochemotherapy in Metastatic TTF-1 Negative Lung Adenocarcinoma
Official Title: Atezolizumab/Carboplatin/Nab-Paclitaxel vs. Pembrolizumab/Platinum/Pemetrexed in Metastatic TTF-1 Negative Lung Adenocarcinoma
Study ID: NCT05689671
Brief Summary: This is an open-label randomized, controlled, multicenter, phase II trial with two arms. Patients with metastatic TTF-1 negative, treatment-naive lung adenocarcinoma without actionable genomic alterations are randomized in a 1:1 manner to investigate the efficiency of atezolizumab, carboplatin and nab-paclitaxel (Arm A) versus pembrolizumab, cis-/carboplatin and pemetrexed (Arm B) as first-line treatment.
Detailed Description: Thyroid transcription factor 1 (TTF-1) is expressed in the majority of lung adenocarcinoma and has a clear prognostic value. Pemetrexed-based immunochemotherapy is a standard of care for advanced lung adenocarcinoma. However, real-world data suggest that TTF-1 negative patients might derive superior outcome using pemetrexed-free regimens. The aim of this study is to compare a pemetrexed-free (Arm A) vs. a pemetrexed-based immunochemotherapy (Arm B) as first-line treatment for metastatic TTF-1 negative lung adenocarcinoma without actionable genomic alterations.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Klinikum St. Marien, Amberg, , Germany
MVZ Taunus GmbH, Bad Homburg, , Germany
Evangelische Lungenklinik Krankenhausbetriebs gGmbH, Berlin, , Germany
Evangelische Lungenklinik, Berlin, , Germany
Charité UniversitÀtsmedizin, Berlin, , Germany
Helios Klinikum Emil von Behring, Berlin, , Germany
Klinikum Bielefeld, Bielefeld, , Germany
Technische UniversitÀt Dresden Medizinische FakultÀt Carl Gustav Carus, Dresden, , Germany
KEM Evang. Kliniken Essen-Mitte, Essen, , Germany
Klinikum Esslingen GmbH, Esslingen, , Germany
UniversitÀtsklinikum Frankfurt am Main, Frankfurt am Main, , Germany
Krankenhaus Nordwest, Frankfurt, , Germany
Asklepios Klinik Gauting GmbH, Gauting, , Germany
LungenClinic GroĂhansdorf GmbH, GroĂhansdorf, , Germany
UniversitÀtsmedizin Göttingen, Göttingen, , Germany
Asklepios Klinkum Hamburg, Hamburg, , Germany
Thoraxklinik Heidelberg gGmbH, Heidelberg, , Germany
Lungenklinik Hemer, Hemer, , Germany
Helios Klinikum Krefeld, Krefeld, , Germany
Kliniken der Stadt Köln GmbH, Köln, , Germany
ĂBAG- Medizinisches Versorgungszentrum Dr. Vehling-Kaiser GmbH, Landshut, , Germany
Klinikum Lippe GmbH, Lemgo, , Germany
Klinikum Ludwigsburg, Ludwigsburg, , Germany
UKSH, Campus LĂŒbeck, LĂŒbeck, , Germany
Medizinische FakultÀt Mannheim der UniversitÀt Heidelberg, Mannheim, , Germany
LMU Klinikum, MĂŒnchen, , Germany
UnversitĂ€tsklinikum MĂŒnster, MĂŒnster, , Germany
Ăberörtliche Gemeinschaftspraxis fĂŒr HĂ€matologie und Onkologie, MĂŒnster, , Germany
Pius Hospital, Oldenburg, , Germany
Barmherzige BrĂŒder Krankenhaus Regensburg, Regensburg, , Germany
Elblandkliniken Stiftung & Co. KG Elblandklinikum Riesa, Riesa, , Germany
Name: Nikolaj Frost, PD Dr.
Affiliation: Charite University, Berlin, Germany
Role: PRINCIPAL_INVESTIGATOR