HER3-DXd (Patritumab Deruxtecan; U3-1402) in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer
A Phase 1 Open-Label Study of HER3-DXd (Patritumab Deruxtecan; U3-1402) in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer (NSCLC)
Sponsor: Daiichi Sankyo + AstraZeneca, Merck Sharp & Dohme LLC
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Dose Escalation: Incidence of Dose-limiting Toxicities (DLT), Treatment-emergent Adverse Events (TEAE), Serious Adverse Events (SAE), Adverse Events of Special Interest (AESI)
Time frame: From signing of informed consent form up to 40 days (+7 days) after the last dose of study drugs, up to approximately 9 months
Second-line Dose Expansion and First-line Dose Expansion: Objective Response Rate (ORR)
Time frame: From start of study treatment until date of documented disease progression or other protocol-defined reason for discontinuation from the study (e.g, withdrawal of consent, lost to follow-up), whichever occurs first, up to approximately 18 months
Secondary Endpoints
Dose Escalation: Objective Response Rate (ORR)
Second-line Dose Expansion and First-line Dose Expansion: Objective Response Rate (ORR)
Dose Escalation, Second-line Dose Expansion, and First-Line Dose Expansion: Duration of Response (DoR)
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria Specific to Dose Escalation and Second-line Dose Expansion: * Documentation of EGFR exon 19 deletion or L858R mutation detected from tumor tissue * Must have received osimertinib for locally advanced or metastatic disease at a dose of 80 mg once daily (QD) for at least 6 weeks and must not miss more than two doses during the 2 weeks prior to the first day of study treatment (Cycle 1, Day 1) * Must not have received any other prior systemic cancer therapies in the locally advanced/metastatic setting * Has documentation of radiological disease progression following first-line treatment with osimertinib in the locally advanced or metastatic setting Inclusion Criteria Specific to First-line Dose Expansion: * The tumor tissue harbors one of the 2 common EGFR mutations occurring in NSCLC known to be associated with EGFR-TKI sensitivity (exon 19 deletion or L858R) as assessed by Clinical Laboratory Improvement Amendments (CLIA)-certified (United Stat…
Read full criteria on CT.gov →✦ Analyst Commentary
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