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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

246

Participants

Timeline

Start Date

June 11, 2021

Primary Completion Date

January 31, 2025

Study Completion Date

April 30, 2027

Conditions
Non-Small Cell Lung Cancer (NSCLC)
Interventions
DRUG

HER3-DXd

Intravenous infusion at a starting dose of 3.2 mg/kg Q3W

DRUG

HER3-DXd

Intravenous infusion at RCD 1 (and at RCD 2 if two provisional RCDs are selected in dose escalation)

DRUG

Osimertinib

Oral administration at 40 mg or 80 mg once daily

DRUG

Osimertinib

Oral administration at RCD 1 (and at RCD 2 if two provisional RCDs are selected in dose escalation)

DRUG

HER3-DXd

Intravenous infusion 5.6 mg/kg Q3W

DRUG

HER3-DXd

Intravenous infusion 4.8 mg/kg Q3W

DRUG

Osimertinib

Oral administration at 80 mg once daily

Trial Locations (31)

100

National Taiwan University Hospital, Taipei

10032

Columbia University Irving Medical Center, New York

10065

Memorial Sloan Kettering Cancer Center, New York

11217

Taipei Veterans General Hospital, Taipei

19104

University of Pennsylvania, Philadelphia

20057

Georgetown University Medical Center, Washington D.C.

22031

Virginia Cancer Specialists, PC, Fairfax

37203

Sarah Cannon and HCA Research Institute, Nashville

40201

Chung Shan Medical University Hospital, Taichung

48202

Henry Ford Cancer Institute, Detroit

60611

Northwestern University Feinberg School of Medicine, Chicago

90404

UCLA, Santa Monica

110301

Taipei Medical University Hospital, Taipei

06510

Yale University School of Medicine - Yale-New Haven Hospital, New Haven

02114

Massachusetts General Hospital Cancer Center, Boston

02215

Dana-Farber Cancer Institute, Boston

03756

Dartmouth-Hitchcock Medical Center, Lebanon

791-0280

National Hospital Organization Shikoku Cancer Center, Matsuyama

811-1395

National Hospital Organization Kyushu Cancer Center, Fukuoka

003-0804

National Hospital Organization Hokkaido Cancer Center, Sapporo

241-8515

Kanagawa Cancer Center, Yokohama

700-8558

Okayama University Hospital, Okayama

104-0045

National Cancer Center Hospital, Chuo Ku

740-8510

National Hospital Organization Iwakuni Clinical Center, Iwakuni-shi

589-8511

Kindai University Hospital, Ōsaka-sayama

411-8777

Shizuoka Cancer Center, Shizuoka

135-8550

The Cancer Institute Hospital of JFCR, Tokyo

03080

Seoul National University Hospital, Seoul

03722

Yonsei University Health System - Severance Hospital, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Daiichi Sankyo

INDUSTRY