Phase II clinical trial - Appareil pulmonaire

HERTHENA-Lung01 U31402-A-U201
Appareil pulmonaire
Ouvert depuis le: 09.20.2021
Site: Paris
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Adulte
HERTHENA-Lung01: A Phase 2 Randomized Open-Label;Study of Patritumab Deruxtecan (U3-1402) in Subjects with;Previously Treated Metastatic or Locally Advanced EGFRmutated;Non-Small Cell Lung Cancer (NSCLC)
Description de l'essai

This is a global, multicenter, open-label, Phase 2 study of subjects with metastatic or locally advanced NSCLC;with an EGFR-activating mutation (exon 19 deletion or L858R) who have received and progressed on or after at;least 1 EGFR TKI and 1 platinum-based chemotherapy-containing regimen. This study will initially randomize;subjects to one of 2 arms in a 1:1 ratio, for dose selection, to receive either a 5.6 mg/kg fixed dose regimen;(Arm 1) or an up-titration dose regimen (Cycle 1: 3.2 mg/kg; Cycle 2: 4.8 mg/kg; Cycle 3 and subsequent;cycles: 6.4 mg/kg; Arm 2) of patritumab deruxtecan on Day 1 of each 21-day cycle.