Lung Cancer Clinical Trial
A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)
Summary
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 (1L) cohort will consist of patients who have not received any systemic therapy for their disease and the second-line (2L) cohort will consist of patients who progressed during or after receiving a platinum-containing regimen and a PD-L1/PD-1 checkpoint inhibitor treatment. In each cohort, eligible patients will be assigned to one of several treatment arms.
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
Availability of peripheral blood for next-generation sequencing (NGS) circulating tumor deoxyribonucleic acid (ctDNA) testing.
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) >= 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
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
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There are 37 Locations for this study
New Haven Connecticut, 06510, United States
Newark Delaware, 19713, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Las Vegas Nevada, 89169, United States
New York New York, 10032, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
Nashville Tennessee, 37203, United States
Blacktown New South Wales, 2148, Australia
East Melbourne Victoria, 3002, Australia
Dijon , 21000, France
Lyon , 69008, France
Marseille , 13005, France
Montpellier , 34298, France
Saint Herblain , 44115, France
Toulouse , 31100, France
Haifa , 31096, Israel
Petach Tikva , 49222, Israel
Ramat Gan , 52621, Israel
Jeollanam-do , 58128, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 08308, Korea, Republic of
Songpa-gu , 05505, Korea, Republic of
Pamplona Navarra, 31620, Spain
Barcelona , 08035, Spain
Madrid , 28014, Spain
Madrid , 28040, Spain
Madrid , 28050, Spain
Malaga , 29010, Spain
Valencia , 46010, Spain
Tainan City , 704, Taiwan
Taipei City , 11217, Taiwan
London , E1 2A, United Kingdom
Newcastle upon Tyne , NE1 4, United Kingdom
Sutton , SM2 5, United Kingdom
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