HER3-DXd (Patritumab Deruxtecan; U3-1402) in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer

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NCT04676477

Sponsored by Daiichi Sankyo (industry) · 4568.T — their whole pipeline →. With AstraZeneca, Merck Sharp & Dohme LLC.

Phase

Phase 1

Status

Active, not recruiting

Study type

Interventional

Design

Randomized · None · Treatment

Enrollment

246actual

Sites

Countries

Japan, South Korea, Taiwan +1

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2021-06-11

actual

When the study began enrolling

Primary completion

2025-01-31

actual

The date the last participant is measured for the primary outcome — the readout window

Study completion

2027-04-30

estimated

The whole study's end, after follow-up

First posted

2020-12-21

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2025-06-22

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Non-Small Cell Lung Cancer (NSCLC)

Interventions

Drug: HER3-DXd — also filed as U3-1402, Patritumab deruxtecan
Drug: HER3-DXd — also filed as U3-1402, Patritumab deruxtecan
Drug: Osimertinib
Drug: Osimertinib
Drug: HER3-DXd — also filed as U3-1402, Patritumab deruxtecan
Drug: HER3-DXd — also filed as U3-1402, Patritumab deruxtecan
Drug: Osimertinib

Primary outcomes

what the primary-completion date above is the date OF

Dose Escalation: Incidence of Dose-limiting Toxicities (DLT), Treatment-emergent Adverse Events (TEAE), Serious Adverse Events (SAE), Adverse Events of Special Interest (AESI)

measured 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)

measured 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

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