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.

View Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

435

Study ID:

NCT03337698

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

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There are 37 Locations for this study

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Smilow Cancer Hospital at Yale New Haven
New Haven Connecticut, 06510, United States
Christiana Care Health Services
Newark Delaware, 19713, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
Las Vegas Nevada, 89169, United States
Columbia University Medical Center; Research Pharmacy, Irving Pavillion, Ip 7-749
New York New York, 10032, United States
University Hospitals Case Medical Center; Seidman Cancer Center
Cleveland Ohio, 44106, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Blacktown Hospital
Blacktown New South Wales, 2148, Australia
Peter Mac Callum Cancer Center
East Melbourne Victoria, 3002, Australia
Centre Georges Francois Leclerc
Dijon , 21000, France
Centre Léon Bérard
Lyon , 69008, France
Hopital de la Timone
Marseille , 13005, France
Institut Régional du Cancer de Montpellier
Montpellier , 34298, France
Institut De Cancerologie De L'Ouest; Medical Oncology
Saint Herblain , 44115, France
Institut Universitaire du Cancer de Toulouse-Oncopole; PHARMACIE
Toulouse , 31100, France
Rambam Medical Center; Oncology
Haifa , 31096, Israel
Rabin Medical Center
Petach Tikva , 49222, Israel
Chaim Sheba Medical Center; Oncology Dept
Ramat Gan , 52621, Israel
Chonnam National University Hwasun Hospital
Jeollanam-do , 58128, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Korea University Guro Hospital
Seoul , 08308, Korea, Republic of
University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC)
Songpa-gu , 05505, Korea, Republic of
Clínica Universidad de Navarra
Pamplona Navarra, 31620, Spain
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain
Hospital Universitario La Paz
Madrid , 28014, Spain
Fundación Jimenez Díaz
Madrid , 28040, Spain
Hospital Universitario HM Sanchinarro-CIOCC
Madrid , 28050, Spain
Hospital Regional Universitario de Malaga
Malaga , 29010, Spain
Hospital Clinico Universitario de Valencia
Valencia , 46010, Spain
National Cheng Kung University Hospital; Gasterointestinal
Tainan City , 704, Taiwan
Taipei Veterans General Hospital
Taipei City , 11217, Taiwan
Barts Cancer Institute
London , E1 2A, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne , NE1 4, United Kingdom
Royal Marsden Hospital; Institute of Cancer Research
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

435

Study ID:

NCT03337698

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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