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
Click here to add this to my saved trials
Click here to add this to my saved trials
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Click here to add this to my saved trials
630 West 168th Street
New York, New York 10032
New York, New York 10032
Click here to add this to my saved trials