Spots Global Cancer Trial Database for 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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Trial Identification
Brief Title: HER3-DXd (Patritumab Deruxtecan; U3-1402) in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer
Official Title: 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)
Study ID: NCT04676477
Conditions
Study Description
Brief Summary: 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.
Detailed Description: Dose Escalation: Population includes subjects with locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation with tumor progression after treatment with osimertinib. The starting combination dose regimen is HER3-DXd 3.2 mg/kg IV every 21 days (Q3W) and osimertinib 80 mg orally (PO) once daily. At least 3 to 6 subjects will be enrolled in each cohort. Dose Expansion: Two subject populations will be evaluated in the Dose Expansion Part: * Second-Line: 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: Subjects with locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation, and without prior systemic therapy for advanced or metastatic disease. Note: The first line expansion will only be initiated if the RCD includes osimertinib 80 mg PO once daily.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCLA, Santa Monica, California, United States
Yale University School of Medicine - Yale-New Haven Hospital, New Haven, Connecticut, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Henry Ford Cancer Institute, Detroit, Michigan, United States
Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
Columbia University Irving Medical Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Sarah Cannon and HCA Research Institute, Nashville, Tennessee, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
National Hospital Organization Shikoku Cancer Center, Matsuyama-shi, Ehime, Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka-shi, Fukuoka, Japan
National Hospital Organization Hokkaido Cancer Center, Sapporo-shi, Hokkaido, Japan
Kanagawa Cancer Center, Yokohama-shi, Kanagawa, Japan
Okayama University Hospital, Okayama-shi, Okayama, Japan
National Cancer Center Hospital, Chuo Ku, Tokyo, Japan
National Hospital Organization Iwakuni Clinical Center, Iwakuni-shi, Yamaguchi, Japan
Shizuoka Cancer Center, Shizuoka, , Japan
The Cancer Institute Hospital of JFCR, Tokyo, , Japan
Kindai University Hospital, Ōsaka-sayama, , Japan
Seoul National University Hospital, Seoul, , Korea, Republic of
Yonsei University Health System - Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Chung Shan Medical University Hospital, Taichung, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Medical University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Contact Details
Name: Global Clinical Leader
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR
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