This study was designed to evaluate safety and antitumor activity of HER3-DXd in two parts: Dose Escalation and Dose Expansion. In Dose Escalation, HER3-DXd was evaluated in participants with metastatic or unresectable NSCLC with epidermal growth factor receptor (EGFR) activating mutation after disease progression during/after EGFR tyrosine kinase inhibitor (TKI) therapy. In Dose Expansion, HER3-DXd will be evaluated in participants with metastatic or unresectable NSCLC with EGFR activating mutation or squamous or non-squamous NSCLC (ie, without EGFR-activating mutations) with disease progression during/after systemic treatment for locally advanced or metastatic disease. In addition, HER3-DXd will be evaluated in participants with locally advanced or metastatic NSCLC whose tumors harbor a KRAS-G12C mutation after progression on the most recent line of therapy (Cohort 5).
Non-Small Cell Lung Cancer (NSCLC)
This study was designed to evaluate safety and antitumor activity of HER3-DXd in two parts: Dose Escalation and Dose Expansion. In Dose Escalation, HER3-DXd was evaluated in participants with metastatic or unresectable NSCLC with epidermal growth factor receptor (EGFR) activating mutation after disease progression during/after EGFR tyrosine kinase inhibitor (TKI) therapy. In Dose Expansion, HER3-DXd will be evaluated in participants with metastatic or unresectable NSCLC with EGFR activating mutation or squamous or non-squamous NSCLC (ie, without EGFR-activating mutations) with disease progression during/after systemic treatment for locally advanced or metastatic disease. In addition, HER3-DXd will be evaluated in participants with locally advanced or metastatic NSCLC whose tumors harbor a KRAS-G12C mutation after progression on the most recent line of therapy (Cohort 5).
U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer
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City of Hope, Duarte, California, United States, 91010
University of California San Diego, La Jolla, California, United States, 92093
Pacific Shores Medical Group, Long Beach, California, United States, 90813
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States, 30322
Massachusetts General Hospital, Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215
Karmanos Cancer Institute, Detroit, Michigan, United States, 48201
Henry Ford Hospital, Detroit, Michigan, United States, 48202
NYU Langone Health - NYU Medical Oncology Associates, New York, New York, United States, 10016-4744
Memorial Sloan-Kettering Cancer Center, New York, New York, United States, 10065
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to
ALL
No
Daiichi Sankyo,
Global Clinical Lead, STUDY_DIRECTOR, Daiichi Sankyo
2026-12-31