A Phase II Study of Amivantamab in Participants With MET Amplification-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP SUB-STUDY)

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Moderate burden on patient More information

Trial Details

Sponsor: SWOG Cancer Research Network (federal)

Phase: 2

Start date: Nov. 3, 2023

Planned enrollment: 88

Last updated in HealthScout: Nov 2024

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Trial ID: NCT06116682
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More trial details at ClinicalTrials.gov More info

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Goal: To evaluate the efficacy of amivantamab-vmjw in improving objective response rates and survival outcomes in patients with MET amplification-positive non-small cell lung cancer (NSCLC).

Patients: The trial is focused on individuals diagnosed with stage IV or recurrent non-small cell lung cancer with MET amplification. Eligible participants require measurable disease and must have progressed following previous treatments. Exclusion criteria include known actionable oncogenic alterations, previous treatment with MET tyrosine kinase inhibitors, and recent exposure to other chemotherapy, etc.

Design: This is a non-randomized, single-arm Phase II trial, specifically targeting a subset of NSCLC patients identified through the Expanded Lung-MAP platform.

Treatments: Participants receive Amivantamab-vmjw, a bispecific antibody targeting EGFR and MET receptors, intravenously, initially over two days and subsequently every two weeks. This investigational drug may reduce tumor growth by targeting MET amplification, a known contributor to cancer proliferation. Early trials indicate its potential effectiveness in NSCLC with this specific genetic alteration.

Outcomes: The primary outcome is the objective response rate. Key secondary outcomes include overall survival, progression-free survival, duration of response, and the incidence and severity of treatment-related toxicities.

Burden on patient: The burden on patients is moderate. Participants undergo regular intravenous administration of amivantamab, with treatment cycles extending indefinitely unless disease progression or unacceptable toxicity occurs. Frequent imaging assessments (CT or MRI) and blood sample collections are required throughout the study for comprehensive monitoring of treatment impact, imposing additional logistical and time commitments compared to standard care.

Eligibility Criteria More information

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

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Sutter Auburn Faith Hospital

Auburn, California, 95602, United States

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Alta Bates Summit Medical Center-Herrick Campus

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Palo Alto Medical Foundation-Fremont

Fremont, California, 94538, United States

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Memorial Medical Center

Modesto, California, 95355, United States

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Palo Alto Medical Foundation Health Care

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Roseville, California, 95661, United States

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California Pacific Medical Center-Pacific Campus

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Santa Rosa, California, 95403, United States

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Bayhealth Hospital Kent Campus

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Milford, Delaware, 19963, United States

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Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706, United States

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Caldwell, Idaho, 83605, United States

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Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, 83687, United States

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Danville, Illinois, 61832, United States

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Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526, United States

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Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

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Carle Physician Group-Effingham

Effingham, Illinois, 62401, United States

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Crossroads Cancer Center

Effingham, Illinois, 62401, United States

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Illinois CancerCare-Eureka

Eureka, Illinois, 61530, United States

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Illinois CancerCare-Galesburg

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Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443, United States

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Macomb, Illinois, 61455, United States

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SSM Health Good Samaritan

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Cancer Care Center of O'Fallon

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Princeton, Illinois, 61356, United States

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Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

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Springfield Clinic

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Carle Cancer Center

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Mary Greeley Medical Center

Ames, Iowa, 50010, United States

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Cancer Hematology Centers - Flint

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Genesee Hematology Oncology PC

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Genesys Hurley Cancer Institute

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University of Michigan Health - Sparrow Lansing

Lansing, Michigan, 48912, United States

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Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154, United States

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Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197, United States

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Baptist Memorial Hospital and Cancer Center-Golden Triangle

Columbus, Mississippi, 39705, United States

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Baptist Cancer Center-Grenada

Grenada, Mississippi, 38901, United States

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Baptist Memorial Hospital and Cancer Center-Union County

New Albany, Mississippi, 38652, United States

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Saint Francis Medical Center

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Parkland Health Center - Farmington

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Sainte Genevieve County Memorial Hospital

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Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080, United States

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BJC Outpatient Center at Sunset Hills

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Billings Clinic Cancer Center

Billings, Montana, 59101, United States

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Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715, United States

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Benefis Sletten Cancer Institute

Great Falls, Montana, 59405, United States

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Community Medical Center

Missoula, Montana, 59804, United States

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OptumCare Cancer Care at Seven Hills

Henderson, Nevada, 89052, United States

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OptumCare Cancer Care at Charleston

Las Vegas, Nevada, 89102, United States

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OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, 89148, United States

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New Hampshire Oncology Hematology PA-Concord

Concord, New Hampshire, 03301, United States

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Solinsky Center for Cancer Care

Manchester, New Hampshire, 03103, United States

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ProMedica Flower Hospital

Sylvania, Ohio, 43560, United States

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University of Oklahoma Health Sciences Center

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Providence Newberg Medical Center

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Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, 97914, United States

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Providence Willamette Falls Medical Center

Oregon City, Oregon, 97045, United States

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WellSpan Medical Oncology and Hematology

Chambersburg, Pennsylvania, 17201, United States

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Ephrata Cancer Center

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Adams Cancer Center

Gettysburg, Pennsylvania, 17325, United States

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Sechler Family Cancer Center

Lebanon, Pennsylvania, 17042, United States

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Cancer Care Associates of York

York, Pennsylvania, 17403, United States

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Collierville, Tennessee, 38017, United States

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Memphis, Tennessee, 38120, United States

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Edwards Comprehensive Cancer Center

Huntington, West Virginia, 25701, United States

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West Virginia University Healthcare

Morgantown, West Virginia, 26506, United States

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