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) |
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.
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
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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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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630 West 168th Street
New York, New York 10032
New York, New York 10032
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