HER3-DXd (Patritumab Deruxtecan; U3-1402) in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer (NCT04676477)
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)
๐ฉบ Plain-English Summary (8th-Grade Level)
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 or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation with tumor progression after treatment with osimertinib. Note: One or both of the study arms may open with one or two distinct dosing schedules. Second-Line Dose Expansion Arm 2: To assess the preliminary antitumor activity of HER3-DXd monotherapy in subjects with locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation with tumor progression after treatment with osimertinib. First-Line Dose Expansion Cohorts 3, 4a, and 4b: To assess the preliminary antitumor activity of HER3-DXd and osimertinib in subjects with locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation without prior systemic treatment for locally advanced or metastatic disease.
Who can join: Review the eligibility criteria below.
Location: UCLA โ Santa Monica, California
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (31 Sites)
Showing the first 25 of 31 sites.
- UCLA โ Santa Monica, California
- Yale University School of Medicine - Yale-New Haven Hospital โ New Haven, Connecticut
- Georgetown University Medical Center โ Washington D.C., District of Columbia
- Northwestern University Feinberg School of Medicine โ Chicago, Illinois
- Massachusetts General Hospital Cancer Center โ Boston, Massachusetts
- Dana-Farber Cancer Institute โ Boston, Massachusetts
- Henry Ford Cancer Institute โ Detroit, Michigan
- Dartmouth-Hitchcock Medical Center โ Lebanon, New Hampshire
- Columbia University Irving Medical Center โ New York, New York
- Memorial Sloan Kettering Cancer Center โ New York, New York
- University of Pennsylvania โ Philadelphia, Pennsylvania
- Sarah Cannon and HCA Research Institute โ Nashville, Tennessee
- Virginia Cancer Specialists, PC โ Fairfax, Virginia
- National Hospital Organization Shikoku Cancer Center โ Matsuyama, Ehime
- National Hospital Organization Kyushu Cancer Center โ Fukuoka, Fukuoka
- National Hospital Organization Hokkaido Cancer Center โ Sapporo, Hokkaido
- Kanagawa Cancer Center โ Yokohama, Kanagawa
- Okayama University Hospital โ Okayama, Okayama-ken
- National Cancer Center Hospital โ Chuo Ku, Tokyo
- National Hospital Organization Iwakuni Clinical Center โ Iwakuni-shi, Yamaguchi
- Kindai University Hospital โ ลsaka-sayama,
- Shizuoka Cancer Center โ Shizuoka,
- The Cancer Institute Hospital of JFCR โ Tokyo,
- Seoul National University Hospital โ Seoul,
- Yonsei University Health System - Severance Hospital โ Seoul,
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Non-Small Cell Lung Cancer (NSCLC)
- Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009) โ Oakland, California
- PCSK9 Inhibitor and PD-1 Inhibitor in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung โ Tampa, Florida
- U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer โ Duarte, California
- Study of Osimertinib and Stereotactic Ablative Radiation (SABR) in EGFR Mutant NSCLC โ Duarte, California
- Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE) โ Birmingham, Alabama
Explore by condition: All Non-Small Cell Lung Cancer (NSCLC) clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.