HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer
HERTHENA-Lung01: A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects With Previously Treated Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer (NSCLC)
Sponsor: Daiichi Sankyo + Daiichi Sankyo Co., Ltd., Merck Sharp & Dohme LLC
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR)
Time frame: Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months
Secondary Endpoints
Duration of Response (DoR)
Progression-free Survival (PFS)
Objective Response Rate (ORR) as Assessed by the Investigator
Eligibility Criteria
Inclusion Criteria: Participants must meet all of the following criteria to be eligible for inclusion in this study. * Sign and date the tissue informed consent form (ICF) and the main ICF, prior to the start of any study-specific qualification procedures. * Male or female participants aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is \>18 years old). * Histologically or cytologically documented locally advanced or metastatic NSCLC not amenable to curative surgery or radiation. * Documentation of radiological disease progression while on/after receiving most recent treatment regimen for locally advanced or metastatic disease. Participants must have received both of the following: * Prior treatment with osimertinib. Participants receiving an EGFR TKI at the time of signing informed consent should continue to take the EGFR TKI until 5 days prior to Cycle 1 Day 1. Participants in South Korea known to harbor a clinically action…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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