Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief Title: 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)
Official Title: Phase 1b, Multicenter, Open-label Study of 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)
Study ID: NCT04526691
Conditions
Study Description
Brief Summary: This study will assess safety and treatment activity of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum chemotherapy in participants with advanced or metastatic non-small cell lung cancer.
Detailed Description: The primary objective of this study will assess safety and treatment activity of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without 4 cycles of platinum chemotherapy in participants with advanced or metastatic NSCLC who have either been previously treated or are treatment naïve in a metastatic setting. Two dose levels of Dato-DXd (4.0 mg/kg and 6.0 mg/kg) will be studied in combination with 200 mg fixed-dose pembrolizumab in 6 study cohorts. This study will be conducted sequentially and dose escalation will occur according to lower dose to higher dose in the same combination regimen (4.0 mg/kg to 6.0 mg/kg) and from 2-drug combination (Dato-DXd and pembrolizumab) to 3-drug combination regimen (Dato-DXd, pembrolizumab, and carboplatin or cisplatin).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic, Scottsdale, Arizona, United States
City of Hope, Duarte, California, United States
Johns Hopkins Kimmel Cancer Center, Washington, District of Columbia, United States
Mayo Clinic, Jacksonville, Florida, United States
Johns Hopkins Kimmel Cancer Center at Bayview, Baltimore, Maryland, United States
The Skip Viragh Outpatient Cancer Building, Baltimore, Maryland, United States
Mayo Clinic, Rochester, Minnesota, United States
Quantum Santa Fe, Santa Fe, New Mexico, United States
NEXT Oncology, San Antonio, Texas, United States
Instituto Europeo Di Oncologica, Milan, , Italy
Azienda Ospedaliera San Gerardo, Monza, , Italy
Istituto Nazionale Tumori Fondazione G. Pascale di Napoli Struttura di Oncologia, Naples, , Italy
National Cancer Center Hospital East, Chiba, , Japan
National Cancer Center Hospital, Tokyo, , Japan
Showa Univeristy Hospital, Tokyo, , Japan
H. Vall Hebrón (Vall Hebron Institut de Oncologia - VHIO), Barcelona, , Spain
START Madrid - Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
(CIOCC-START) Hospital Universitario HM Sanchinarro, Madrid, , Spain
Hospital Puerta de Hierro, Majadahonda, , Spain
Chung Shan Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital NCKUH, Tainan, , Taiwan
National Taiwan University Hospital NTUH, Taipei City, , Taiwan
Contact Details
Name: Global Clinical Leader
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR
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