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

Launched by HOFFMANN-LA ROCHE · Nov 7, 2017

Keywords

ClinConnect Summary

This clinical trial, called the Morpheus Study, is looking at different combinations of immunotherapy treatments for patients with metastatic non-small cell lung cancer (NSCLC), which is a type of lung cancer that has spread beyond the lungs. The study aims to find out how effective and safe these treatments are. There are two groups of participants: the first group includes those who have not received any prior treatment for their cancer, while the second group includes those whose cancer has progressed after receiving specific treatments.

To be eligible for the trial, participants should be between 65 and 74 years old, have a good performance status (meaning they are able to carry out daily activities), and have measurable cancer that can be treated. Participants will first receive one of the study's treatment combinations, and if their cancer worsens or they experience unacceptable side effects, they may switch to a different treatment option. It’s important to know that potential participants must also agree to certain guidelines regarding pregnancy and reproductive health. Overall, this trial hopes to provide new insights into treating this challenging form of cancer.

Gender

ALL

Eligibility criteria

• • 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 and agreement to refrain from donating eggs 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) or TCs \>= 50% or TC3
• • 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
• • 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