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Brief Title: A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)
Official Title: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Non-Small Cell Lung Cancer (Morpheus-Lung)
Study ID: NCT03337698
Brief Summary: This study will evaluate the efficacy, safety, and pharmacokinetics of immunotherapy-based treatment combinations in participants with metastatic non-small cell lung cancer (NSCLC). Two cohorts will be enrolled in parallel in this study: Cohort 1 will consist of participants with tumor PD-L1 expression who have received no prior systemic therapy for metastatic NSCLC, and Cohort 2 will consist of participants who experienced disease progression during or following treatment with a platinum-containing regimen and a PD-L1/PD-1 checkpoint inhibitor, given in combination as one line of therapy or as two separate lines of therapy, regardless of PD-L1 expression. In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). Participants who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment regimen (Stage 2).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Smilow Cancer Hospital at Yale New Haven, New Haven, Connecticut, United States
Christiana Care Health Services, Newark, Delaware, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley, Las Vegas, Nevada, United States
Columbia University Medical Center; Research Pharmacy, Irving Pavillion, Ip 7-749, New York, New York, United States
University Hospitals Case Medical Center; Seidman Cancer Center, Cleveland, Ohio, United States
SCRI Oncology Partners, Nashville, Tennessee, United States
Blacktown Hospital, Blacktown, New South Wales, Australia
Peter Mac Callum Cancer Center, East Melbourne, Victoria, Australia
CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre, Bordeaux, , France
Centre Georges Francois Leclerc, Dijon, , France
Centre Léon Bérard, Lyon, , France
Hopital de la Timone, Marseille, , France
Institut Régional du Cancer de Montpellier, Montpellier, , France
Institut De Cancerologie De L'Ouest; Medical Oncology, Saint Herblain, , France
Institut Universitaire du Cancer de Toulouse-Oncopole; PHARMACIE, Toulouse, , France
Rambam Medical Center; Oncology, Haifa, , Israel
Rabin Medical Center, Petach Tikva, , Israel
Chaim Sheba Medical Center; Oncology Dept, Ramat Gan, , Israel
Chonnam National University Hwasun Hospital, Jeollanam-do, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC), Songpa-gu, , Korea, Republic of
Clínica Universidad de Navarra, Pamplona, Navarra, Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Fundación Jimenez Díaz, Madrid, , Spain
Hospital Universitario HM Sanchinarro-CIOCC, Madrid, , Spain
Hospital Regional Universitario de Malaga, Malaga, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
National Cheng Kung University Hospital; Gasterointestinal, Tainan City, , Taiwan
Taipei Veterans General Hospital, Taipei City, , Taiwan
Barts Cancer Institute, London, , United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, , United Kingdom
Royal Marsden Hospital; Institute of Cancer Research, Sutton, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR