A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)



Status:Recruiting
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/4/2019
Start Date:December 27, 2017
End Date:April 16, 2022
Contact:Reference Study ID Number: BO39610 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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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)

This study will evaluate the efficacy, safety, and pharmacokinetics of immunotherapy-based
treatment combinations in patients with metastatic non-small cell lung cancer (NSCLC).

Two cohorts will be enrolled in parallel in this study: the first-line cohort will consist of
patients who have not received any systemic therapy for their disease and the second-line
cohort will consist of patients who progressed after receiving a platinum-containing
chemotherapy regimen and a checkpoint-inhibitor treatment. In each cohort, eligible patients
will be assigned to one of several treatment arms.


General Inclusion Criteria

- Eastern Cooperative Oncology Group (ECOG) performance Status of 0 or 1

- Life expectancy greater than or equal to 3 months

- Histologically or cytologically confirmed metastatic, non-squamous or squamous
Non-Small Cell Lung Cancer (NSCLC)

- Measurable disease (at least one target lesion)

- Adequate hematologic and end-organ function

- Tumor accessible for biopsy

- For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraceptive measures as outlined for each specific
treatment arm

- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use
contraceptive measures, and agreement to refrain from donating sperm, as outlined for
each specific treatment arm

Inclusion Criteria for Cohort 1

- No prior systemic therapy for metastatic NSCLC

- High tumor PD-L1 expression, defined as Tumor Proportion Score (TPS) >= 50%

Inclusion Criteria for Cohort 2

- Disease progression during or following treatment for metastatic or locally advanced,
inoperable NSCLC

Exclusion Criteria

- Prior allogeneic stem cell or solid organ transplantation

- Current treatment with anti-viral therapy for hepatitis B virus (HBV)

- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent
drainage procedures (once monthly or more frequently)

- Symptomatic, untreated, or actively progressing central nervous system (CNS)
metastases

- History of leptomeningeal disease

- Active or history of autoimmune disease or immune deficiency

- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis
obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of
active pneumonitis on screening chest computed tomography scan

- History of malignancy other than NSCLC within 2 years prior to screening

- Active tuberculosis

- Severe infection within 4 weeks prior to initiation of study treatment
We found this trial at
6
sites
3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, TN
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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305 Grattan Street
East Melbourne, Victoria 3000
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East Melbourne,
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New Haven, Connecticut 06520
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New Haven, CT
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New York, NY
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