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A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)
Sponsor: Hoffmann-La Roche
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).
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
314
Start Date
2017-12-27
Completion Date
2025-11-25
Last Updated
2026-05-12
Healthy Volunteers
No
Conditions
Interventions
Atezolizumab
Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.
Cobimetinib
Cobimetinib is administered orally on Days 1-21 of a 28 day cycle.
RO6958688
Cycle 1: RO6958688 is administered by IV infusion on Days 1, 8, and 15 of a 21 day cycle at increasing dosage. Subsequent cycles: RO6958688 is administered by IV infusion on Days 1, 8, and 15 of a 21 day cycle.
Docetaxel
Docetaxel is administered by IV on Day 1 of each 21 day cycle.
CPI-444
CPI-444 is administered orally twice daily on Days 1- 21, of a 21 day cycle.
Pemetrexed
Pemetrexed is administered by IV on Day 1 of a 21 day cycle.
Carboplatin
Carboplatin is administered by IV on day 1 of the first 4 or 6 cycles out of a 21 day cycle.
Gemcitabine
Gemcitabine is administered by IV on Days 1 and 8 of the first 4 or 6 cycles out of a 21 day cycle.
Linagliptin
Linagliptin is administered orally once daily on Days 1 to 21 out of a 21 day cycle.
Tocilizumab
Tocilizumab is administered for the management of cytokine-release syndrome in the RO6958688-containing arms.
Ipatasertib
Ipatasertib will be administered orally once a day on Days 1-21 of each 28-day cycle.
Bevacizumab
Bevacizumab is administered by IV on Day 1 of each 21-day cycle.
Sacituzumab Govitecan
Sacituzumab Govitecan is administered by IV on Day 1 and 8 of each 21-day cycle.
Radiation
Radiotherapy up to 21 days
Evolocumab
Evolocumab is administered subcutaneously at a dose of 140 mg on Days 1 and 15 of each 28-day cycle.
Tiragolumab
Tiragolumab is administered on Day 1 of each 21 day cycle.
XL092
XL092 is administered orally once a day on Day 1 to Day 21 of a 21 day cycle.
Camonsertib
Camonsertib is administered orally on Days 1-3, Days 8-10 of a 21 day cycle.
Locations (29)
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
Las Vegas, Nevada, United States
Columbia University Medical Center
New York, New York, United States
University Hospitals Case Medical 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
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
Saint-Herblain, France
Institut Universitaire du Cancer de Toulouse-Oncopole
Toulouse, France
Rambam Medical Center
Haifa, Israel
Rabin Medical Center
Petah Tikva, Israel
Chaim Sheba Medical Center
Ramat Gan, Israel
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC)
Songpa-gu, South Korea
Clínica Universidad de Navarra
Pamplona, Navarre, 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
Málaga, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Barts Cancer Institute
London, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom
Royal Marsden Hospital
Sutton, United Kingdom