Datopotamab Deruxtecan (Dato-DXd) in Combination With Pembrolizumab With or Without Platinum Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-Lung02)

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

145

Participants

Timeline

Start Date

September 15, 2020

Primary Completion Date

April 15, 2026

Study Completion Date

April 15, 2026

Conditions
Advanced or Metastatic NSCLC
Interventions
DRUG

Datopotamab deruxtecan

Intravenous infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle (starting datopotamab deruxtecan dose of 4.0 mg/kg)

DRUG

KEYTRUDA®

Intravenous infusion Q3W on Day 1 of each 21-day cycle (fixed pembrolizumab dose 200 mg Q3W)

DRUG

Carboplatin

Intravenous infusion Q3W on Day 1 or Day 2 of each 21-day cycle (AUC 5)

DRUG

Cisplatin

Intravenous infusion Q3W on Day 1 or Day 2 of each 21-day cycle (75 mg/m\^2)

Trial Locations (24)

100

National Taiwan University Hospital NTUH, Taipei

704

National Cheng Kung University Hospital NCKUH, Tainan City

20016

Johns Hopkins Kimmel Cancer Center, Washington D.C.

20052

Azienda Ospedaliera San Gerardo, Monza

20141

Instituto Europeo Di Oncologica, Milan

21224

Johns Hopkins Kimmel Cancer Center at Bayview, Baltimore

21287

The Skip Viragh Outpatient Cancer Building, Baltimore

28040

START Madrid - Hospital Universitario Fundacion Jimenez Diaz, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28050

(CIOCC-START) Hospital Universitario HM Sanchinarro, Madrid

28222

Hospital Puerta de Hierro, Majadahonda

32224

Mayo Clinic, Jacksonville

40201

Chung Shan Medical University Hospital, Taichung

40705

Taichung Veterans General Hospital, Taichung

55905

Mayo Clinic, Rochester

78229

NEXT Oncology, San Antonio

80131

Istituto Nazionale Tumori Fondazione G. Pascale di Napoli Struttura di Oncologia, Naples

85259

Mayo Clinic, Scottsdale

87505

Quantum Santa Fe, Santa Fe

91010

City of Hope, Duarte

277-8577

National Cancer Center Hospital East, Chiba

104-0045

National Cancer Center Hospital, Tokyo

142-8555

Showa Medical University Hospital, Tokyo

08035

H. Vall Hebrón (Vall Hebron Institut de Oncologia - VHIO), Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Daiichi Sankyo

INDUSTRY