Spots Global Cancer Trial Database for Phase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: Phase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer
Official Title: A Phase 1b, Multicenter, 2-Part, Open-Label Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Immunotherapy With or Without Carboplatin in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (Tropion-Lung04)
Study ID: NCT04612751
Conditions
Study Description
Brief Summary: This study will assess safety, tolerability, and treatment activity of datopotamab deruxtecan (Dato-DXd) in combination with immunotherapy in participants with advanced or metastatic non-small cell lung cancer (NSCLC).
Detailed Description: The primary objective is to assess the safety and tolerability of Dato-DXd in combination with immunotherapy with or without 4 cycles of carboplatin in participants with advanced or metastatic NSCLC. Two dose levels of Dato-DXd will be studied in combination with immunotherapy (durvalumab, AZD2936, MEDI5752, or AZD7789) with or without 4 cycles of carboplatin in 14 study cohorts Each cohort will start with Part 1 (dose escalation or confirmation), where 3 to 9 participants will be assessed for dose-limiting toxicities (DLT) in the first cycle of treatment. if the DLT incidence rate meets the criteria based on the modified toxicity probability interval-2 (mTPI-2), then Part 2 (dose expansion) may be opened.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Duarte, California, United States
Research Site, La Jolla, California, United States
Research Site, Santa Ana, California, United States
Research Site, Tyrone, Georgia, United States
Research Site, Chicago, Illinois, United States
Research Site, Detroit, Michigan, United States
Research Site, Saint Louis, Missouri, United States
Research Site, Lebanon, New Hampshire, United States
Research Site, Hackensack, New Jersey, United States
Research Site, New York, New York, United States
Research Site, Cleveland, Ohio, United States
Research Site, Hershey, Pennsylvania, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Nashville, Tennessee, United States
Research Site, Dallas, Texas, United States
Research Site, Houston, Texas, United States
Research Site, San Antonio, Texas, United States
Research Site, Fairfax, Virginia, United States
Research Site, Hasselt, , Belgium
Research Site, Mechelen, , Belgium
Research Site, Roeselare, , Belgium
Research Site, Paris Cedex 05, , France
Research Site, Aviano, , Italy
Research Site, Meldola, , Italy
Research Site, Milano, , Italy
Research Site, Orbassano, , Italy
Research Site, Roma, , Italy
Research Site, Koto-ku, , Japan
Research Site, Sunto-gun, , Japan
Research Site, Yokohama-shi, , Japan
Research Site, Busan, , Korea, Republic of
Research Site, Cheongiu, , Korea, Republic of
Research Site, Hwasun-gun, , Korea, Republic of
Research Site, JinJoo, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Suwon-si, , Korea, Republic of
Research Site, Suwon, , Korea, Republic of
Research Site, Gdańsk, , Poland
Research Site, Poland, , Poland
Research Site, Warszawa, , Poland
Research Site, Łódź, , Poland
Research Site, Łódź, , Poland
Research Site, A Coruña, , Spain
Research Site, Badalona, , Spain
Research Site, Barcelona, , Spain
Research Site, Barcelona, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Pozuelo de Alarcon, , Spain
Research Site, Sevilla, , Spain
Research Site, Changhua, , Taiwan
Research Site, Hsinchu, , Taiwan
Research Site, Kaohsiung City, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Tainan, , Taiwan
Research Site, Taipei City, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taoyuan, , Taiwan
Research Site, Adana, , Turkey
Research Site, Ankara, , Turkey
Research Site, Ankara, , Turkey
Research Site, Ankara, , Turkey
Research Site, Istanbul, , Turkey
Research Site, Izmir, , Turkey
Research Site, Konya, , Turkey
Research Site, Malatya, , Turkey
Contact Details
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