HER3-DXd (Patritumab Deruxtecan; U3-1402) in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer
Active, not recruiting · Phase 1 · NCT04676477
Conditions: Non-Small Cell Lung Cancer (NSCLC)
At a glance
- Research payments reported, 2025
- $6.3M
- U.S. investigators named
- 15
- Sites paid
- 12
- Planned or actual enrollment
- 246
About the trial
- Sponsor
- Daiichi Sankyo (with AstraZeneca, Merck Sharp & Dohme LLC)
- Tested
- HER3-DXd (drug), HER3-DXd (drug), Osimertinib (drug), Osimertinib (drug), HER3-DXd (drug), HER3-DXd (drug), Osimertinib (drug)
- Dates
- Started 2021-06-11; completion 2027-12-14
- Results posted
- Not yet
This study includes a Dose Escalation Part to identify the recommended combination dose (RCD) and a Dose Expansion Part to further evaluate efficacy and safety. The primary objectives: Dose Escalation: To assess the safety and tolerability of HER3-DXd (patritumab deruxtecan; U3-1402) and osimertinib in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC) with an EGFR exon 19 deletion or L858R mutation with tumor progression after treatment with osimertinib, and to determine the recommended combination dose (RCD). Second-Line Dose Expansion Arm 1 and Arm 1b: To assess the preliminary antitumor activity of HER3-DXd and osimertinib in subjects with locally advanced…
From ClinicalTrials.gov, last updated 2026-10-26. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Daiichi Sankyo Inc. reported $6.3M in research payments for this study in 2025 (135 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Edward B. Garon, MD Hematology & Oncology · Los Angeles, CA
- Sarah B. Goldberg, M.D., M.P.H. Medical Oncology · New Haven, CT
- Chul Kim Hematology & Oncology · Washington, DC
- Divya M. Gupta, MD Hematology & Oncology · Chicago, IL
- Jyoti Patel, MD Medical Oncology · Chicago, IL
- Pasi Antero Janne, MD PHD Medical Oncology · Boston, MA
- Zofia Piotrowska, MD Medical Oncology · Boston, MA
- Shirish M. Gadgeel, MD Medical Oncology · Detroit, MI
- Keisuke Shirai, MD Hematology & Oncology · Lebanon, NH
- Catherine A. Shu Medical Oncology · New York, NY
- Helena Yu, MD Internal Medicine · New York, NY
- Charu Aggarwal, MD, MPH Hematology & Oncology · Philadelphia, PA
- Melina E. Marmarelis, M.D. Internal Medicine · Philadelphia, PA
- Melissa L. Johnson, MD Medical Oncology · Nashville, TN
- Alexander I. Spira, M.D. Medical Oncology · Fairfax, VA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Dana-Farber Cancer Institute $1.7M
- Virginia Cancer Specialists Fairfax $964,653
- The Trustees of Columbia University in The City of New York $846,653
- Georgetown University $760,027
- David H Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center $701,489
- Northwestern University $545,192
- Hospital of Univ of Pennsylvania, PA $252,846
- Yale University $203,698
- Henry Ford Health Hospital, MI $146,149
- Ronald Reagan UCLA Medical Center, CA $114,340
- Mary Hitchcock Memorial Hospital, NH $39,733
- Sarah Cannon Research Institute $32,498
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.