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Rationale and design of the phase II ANTELOPE study of atezolizumab, carboplatin and nab-Paclitaxel vs. pembrolizumab, platinum and pemetrexed in TTF-1 negative, metastatic lung adenocarcinoma (AIO-TRK-0122)

Introduction - Pemetrexed-based immunochemotherapy represents an established standard of care as first line treatment for non-oncogenic driven metastatic non-small cell lung adenocarcinoma (NSCLC/ADC). However, retrospective analyses revealed better outcomes for pemetrexed-free regimens compared to...

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Main Authors: Frost, Nikolaj (Author) , Bleckmann, Annalen (Author) , Griesinger, Frank (Author) , Grohé, Christian (Author) , Janning, Melanie (Author) , Kollmeier, Jens (Author) , Reinmuth, Niels (Author) , Sebastian, Martin (Author) , Thomas, Michael (Author) , Reck, Martin (Author)
Format: Article (Journal)
Language:English
Published: September 2023
In: Clinical lung cancer
Year: 2023, Volume: 24, Issue: 6, Pages: 568-572
ISSN:1938-0690
DOI:10.1016/j.cllc.2023.04.009
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.cllc.2023.04.009
Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S1525730423000761
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Author Notes:Nikolaj Frost, Annalen Bleckmann, Frank Griesinger, Christian Grohé, Melanie Janning, Jens Kollmeier, Niels Reinmuth, Martin Sebastian, Michael Thomas, Martin Reck
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Summary:Introduction - Pemetrexed-based immunochemotherapy represents an established standard of care as first line treatment for non-oncogenic driven metastatic non-small cell lung adenocarcinoma (NSCLC/ADC). However, retrospective analyses revealed better outcomes for pemetrexed-free regimens compared to pemetrexed-containing regimens in patients with thyroid transcription factor 1 (TTF-1) negative NSCLC/ADC. The multicenter, phase II, randomized, open-label ANTELOPE trial evaluates whether atezolizumab, carboplatin and nab-paclitaxel is superior to pembrolizumab, cis-/carboplatin and pemetrexed in TTF-1 negative NSCLC/ADC. - Methods - Eligible participants are ≥18 years of age, with histologically or cytologically confirmed, treatment-naïve stage IV TTF-1 negative NSCLC/ADC without actionable genomic alterations or PD-L1-overexpression (TPS ≥50%) and will be randomized in a 1:1 fashion to pemetrexed-free (group A) vs. pemetrexed-based (group B) immunochemotherapy. The primary endpoint of this trial is overall survival (OS). - Results - Enrollment will start in Q2 2023 at 30 sites in Germany with a planned inclusion of 136 participants. - Conclusion - ANTELOPE will provide efficacy outcomes of the current standard-of-care for the specific subset of TTF-1 negative NSCLC/ADC in a head-to-head comparison of approved immunochemotherapy regimens.
Item Description:Online verfügbar 23 April 2023, Version des Artikels 22 August 2023
Gesehen am 08.12.2023
Physical Description:Online Resource
ISSN:1938-0690
DOI:10.1016/j.cllc.2023.04.009

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