Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief Title: 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)
Official Title: 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)
Study ID: NCT05281406
Study Description
Brief Summary: PACE is a prospective multicenter single-arm investigator-initiated phase II trial that examines the value of a treatment escalation strategy by the addition of platinum-based doublet chemotherapy to osimertinib in patients with treatment-naïve NSCLC harboring L858R or del19 EGFR mutation who are suspected to have poor response upon single-agent TKI treatment.
Detailed Description: Hypothesize, that in patients with on-label osimertinib 1st-line treatment of stage IIIB or IV NSCLC, a biomarker-driven escalation of osimertinib therapy with a platinum-based chemotherapy regimen will effectively enhance PFS and subsequently OS. Lack of EGFRm clearance after an osimertinib treatment period of 3 weeks as assessed by liquid biopsy will be used to predict sub-optimal response. In these patients, treatment will be escalated after approx. 7 weeks of on-label osimertinib monotherapy by adding up to 4 cycles of a combination regimen of pemetrexed and cisplatin or carboplatin. Patients with complete EGFR plasma clearance will continue to receive standard of care osimertinib and will not be eligible for the study. Primary outcome measure will be PFS, which will be compared to historical data on TKI monotherapy from persistent EGFR shedder from the FLAURA trial.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Charité Universitätsmedizin Berlin Campus Virchow Klinikum Klinik mit Schwerpunkt Infektiologie und Pneumologie, Berlin, , Germany
Technische Universität Dresden Medizinische Fakultät Carl Gustav Carus Medizinische Klinik und Poliklinik I, Dresden, , Germany
Universitätsklinikum Essen, Westdeutsches Tumorzentrum - Innere Klinik, Essen, , Germany
University Hospital Frankfurt, Frankfurt, , Germany
MVZ II der Niels Stensen Kliniken; Franziskus Hospital Harderberg, Georgsmarienhütte, , Germany
Universitätsmedizin Göttingen, Klinik für Hämatologie und Medizinische Onkologie, Göttingen, , Germany
Krankenhaus Martha-Maria Halle-Dölau Klinik für Innere Medizin II, Halle, , Germany
Universitätsklinikum Hamburg-Eppendorf Hubertus Wald Tumorzentrum - UCCH II. Medizinische Klinik und Poliklinik, Hamburg, , Germany
Universitätsklinikum Heidelberg, Thoraxklinik Heidelberg gGmbH, Heidelberg, , Germany
Universitätsklinik Köln, Lung Cancer Group Cologne - Innere Medizin I, Köln, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz, , Germany
LMU-München Pneumologie und Thorakale Onkologie Medizinische Klinik V; Innenstadt, München, , Germany
Klinikum Nürnberg Nord Paracelsus Med. Privat Universität Pneumologie und Lungentumorzentrum, Nürnberg, , Germany
Pius Hospital Oldenburg Medizinischer Campus Universität Oldenburg, Oldenburg, , Germany
Contact Details
Name: Martin Sebastian, MD
Affiliation: Goethe University Frankfurt
Role: PRINCIPAL_INVESTIGATOR
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