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A Phase II Study of Amivantamab SC (Subcutaneous) in Participants With MET Amplification-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP SUB-STUDY)
This phase II Expanded Lung-MAP treatment trial tests how well amivantamab-subcutaneous (SC) works in treating patients patients with MET amplification non-small cell lung cancer. Amivantamab-SC is a drug that reduces extra copies of the MET gene, a change present in your tumor. Giving amivantamab-SC may lower the chance of the growth or spread of advanced non-small cell lung cancer that has extra copies of the MET gene in the tumor.
PRIMARY OBJECTIVE: I. To evaluate the objective response rate (ORR) (confirmed and unconfirmed, complete and partial) in participants with MET amplification-positive non-small cell lung cancer (NSCLC) treated with amivantamab-SC within each cohort. SECONDARY OBJECTIVES: I. To evaluate progression-free survival (PFS) within each cohort. II. To evaluate overall survival (OS) within each cohort. III. To evaluate the duration of response among responders within each cohort. IV. To evaluate the frequency and severity of toxicities within each cohort and combined across all study participants. TRANSLATIONAL MEDICINE OBJECTIVES: I. To collect, process, and bank cell-free deoxyribonucleic acid (cfDNA) prior to treatment on Cycle 1 Day 1, Cycle 3 Day 1, and at first progression for future development of a proposal to evaluate comprehensive next-generation sequencing of circulating tumor deoxyribonucleic acid (ctDNA). II. To establish a tissue/blood repository from participants with refractory non-small cell lung cancer (NSCLC). OUTLINE: Patients receive amivantamab subcutaneously (SC) on days 1, 8, 15, and 22 of cycle 1 and then on days 1 and 15 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo computerized tomography (CT) or magnetic resonance imaging (MRI) and collection of blood samples throughout the trial. After completion of study treatment, patients are followed up for up to 3 years.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Sutter Auburn Faith Hospital
Auburn, California, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
Palo Alto Medical Foundation-Fremont
Fremont, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Memorial Medical Center
Modesto, California, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States
Eisenhower Medical Center
Rancho Mirage, California, United States
Start Date
November 19, 2024
Primary Completion Date
May 31, 2028
Completion Date
May 31, 2028
Last Updated
December 5, 2025
88
ESTIMATED participants
Amivantamab
BIOLOGICAL
Biospecimen Collection
PROCEDURE
Computed Tomography
PROCEDURE
Magnetic Resonance Imaging
PROCEDURE
Lead Sponsor
SWOG Cancer Research Network
Collaborators
NCT03191149
NCT06498635
Data Source & Attribution
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