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)

Status: Recruiting
Location: See all (99) locations...
Intervention Type: Procedure, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants must have been assigned to S1900J by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1900J is determined by the LUNGMAP protocol

• Participants must have documentation of NSCLC with MET amplification determined by FMI tissue-based next generation sequencing (NGS) assay

• Participants must have measurable disease documented by CT or MRI. The CT from a combined positron emission tomography (PET)/CT may be used to document measurable disease ONLY if it is of diagnostic quality: otherwise, it may be used to document non-measurable disease only. Measurable disease must be assessed within 28 days prior to sub-study registration. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to sub-study registration. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to sub-study registration to be considered measurable

• Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study registration

• Participants with asymptomatic CNS metastasis (brain metastases or leptomeningeal disease) must be clinically stable and asymptomatic for at least 14 days prior to sub-study registration

⁃ NOTE: Participants can be on a low-dose corticosteroid treatment (≤ 10 mg prednisone or equivalent) for at least 14 days prior to study treatment

• Participants must not have other known actionable oncogenic alterations, such as (but not limited to) EGFR sensitizing mutations, EGFR T790M mutation, MET Exon-14 skipping mutant NSCLC, ALK gene fusion, ROS1 gene rearrangement, RET gene rearrangement, NTRK rearrangement, HER2 mutation, KRAS activating mutations, and BRAF V600E mutation

• Participants must have progressed (in the opinion of the treating physician) following the most recent line of therapy

• Participants must have received at least one line of systemic treatment for Stage IV or recurrent NSCLC

• Participants must have recovered (≤ Grade 1) from any side effects of prior therapy. The exception is if a side effect from a prior treatment is known to be permanent without expected further recovery or resolution (i.e., endocrinopathy from immunotherapy or cisplatin neurotoxicity)

• Participants must not have been previously treated for any cancer with MET tyrosine kinase inhibitors (TKIs) such as tepotinib, capmatinib, and crizotinib

• Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study registration

• Participants must not have a prior treatment with anti-PD-1 or anti-PD-L1 antibody within 6 weeks of sub-study registration

• Participants must not have received any radiation therapy within 14 days prior to sub-study registration

• Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study

• Participants must not have had major surgery excluding placement of vascular access or tumor biopsy, or had significant traumatic injury within 28 days prior to sub-study registration, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study

⁃ NOTE: Participants with planned surgical procedures to be conducted under local anesthesia may participate

• Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen

• Absolute neutrophil count ≥ 1.5 x 10\^3/uL (within 28 days prior to sub-study registration)

• Hemoglobin \>= 10.0 g/dL (within 28 days prior to sub-study registration)

• Platelets ≥ 75 x 10\^3/uL (within 28 days prior to sub-study registration)

• Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 28 days prior to sub-study registration)

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × institutional ULN. Participants with history of liver metastasis must have AST and ALT ≤ 5 x ULN (within 28 days prior to sub-study registration)

• Participants must have a serum creatinine ≤ the institutional upper limit of normal (IULN) or calculated creatinine clearance ≥ 45 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to sub-study registration. For creatinine clearance formula see the tools on the CRA Workbench

• Participants' most recent Zubrod performance status must be 0-2 and be documented within 28 days prior to sub-study registration

• Participants must have a completed medical history and physical exam within 28 days prior to sub-study registration

• Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better

• Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy and have undetectable viral load test on the most recent test results obtained within 6 months prior to sub-study registration

• Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to sub-study registration

• Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to sub-study registration

• Participants with known diabetes as determined by the treating investigator must show evidence of controlled disease within 14 days prior to sub-study registration

• Participants of reproductive potential must have a negative serum pregnancy test within 7 days prior to sub-study registration

• Participants must not have other clinically active infectious liver disease

• Participants must not have clinically significant hypertension within 28 days prior to sub-study registration as determined by the treating investigator

• Participants must not have a history of pneumonitis that required drug therapy or an active symptomatic interstitial lung disease (ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis

• Participants must not have ongoing or active infection or be diagnosed or suspected viral infection as determined by the treating investigator. NOTE: Participants that have an infection requiring antimicrobial therapy will be required to complete antibiotics 1 week prior to starting treatment

• Participants must not have active bleeding diathesis as determined by the treating investigator

• Participants must not have impaired oxygenation requiring continuous oxygen supplementation as determined by the treating investigator

• Participants must not have psychiatric illness, social situation, or any other circumstances that would limit compliance with study requirements as determined by the treating investigator

• Participants must not have any ophthalmologic condition that is unstable in the opinion of the treating investigator

• Participants must not be pregnant or breastfeeding (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of reproductive potential. In addition to routine contraceptive methods, effective contraception also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen

• Participants must agree to have blood specimens submitted for circulating tumor DNA (ctDNA)

• Participants must also be offered participation in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System

• Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines

⁃ NOTE: Participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations

Locations
United States
Arkansas
University of Arkansas for Medical Sciences
RECRUITING
Little Rock
California
Sutter Auburn Faith Hospital
RECRUITING
Auburn
Alta Bates Summit Medical Center-Herrick Campus
RECRUITING
Berkeley
Palo Alto Medical Foundation-Fremont
RECRUITING
Fremont
Memorial Medical Center
RECRUITING
Modesto
Palo Alto Medical Foundation Health Care
RECRUITING
Palo Alto
Sutter Roseville Medical Center
RECRUITING
Roseville
California Pacific Medical Center-Pacific Campus
RECRUITING
San Francisco
Sutter Pacific Medical Foundation
RECRUITING
Santa Rosa
Palo Alto Medical Foundation-Sunnyvale
RECRUITING
Sunnyvale
Sutter Solano Medical Center/Cancer Center
RECRUITING
Vallejo
Delaware
Bayhealth Hospital Kent Campus
RECRUITING
Dover
Bayhealth Hospital Sussex Campus
RECRUITING
Milford
Georgia
Northeast Georgia Medical Center-Gainesville
RECRUITING
Gainesville
Iowa
Mary Greeley Medical Center
RECRUITING
Ames
McFarland Clinic - Ames
RECRUITING
Ames
McFarland Clinic - Boone
RECRUITING
Boone
McFarland Clinic - Trinity Cancer Center
RECRUITING
Fort Dodge
McFarland Clinic - Jefferson
RECRUITING
Jefferson
McFarland Clinic - Marshalltown
RECRUITING
Marshalltown
Idaho
Saint Alphonsus Cancer Care Center-Boise
RECRUITING
Boise
Saint Alphonsus Cancer Care Center-Caldwell
RECRUITING
Caldwell
Kootenai Health - Coeur d'Alene
RECRUITING
Coeur D'alene
Saint Alphonsus Cancer Care Center-Nampa
RECRUITING
Nampa
Kootenai Clinic Cancer Services - Post Falls
RECRUITING
Post Falls
Kootenai Clinic Cancer Services - Sandpoint
RECRUITING
Sandpoint
Illinois
Illinois CancerCare-Bloomington
RECRUITING
Bloomington
Illinois CancerCare-Canton
RECRUITING
Canton
Illinois CancerCare-Carthage
RECRUITING
Carthage
Carle at The Riverfront
RECRUITING
Danville
Cancer Care Specialists of Illinois - Decatur
RECRUITING
Decatur
Decatur Memorial Hospital
RECRUITING
Decatur
Carle Physician Group-Effingham
RECRUITING
Effingham
Crossroads Cancer Center
RECRUITING
Effingham
Illinois CancerCare-Eureka
RECRUITING
Eureka
Illinois CancerCare-Galesburg
RECRUITING
Galesburg
Illinois CancerCare-Kewanee Clinic
RECRUITING
Kewanee
Illinois CancerCare-Macomb
RECRUITING
Macomb
Carle Physician Group-Mattoon/Charleston
RECRUITING
Mattoon
SSM Health Good Samaritan
RECRUITING
Mount Vernon
Cancer Care Center of O'Fallon
RECRUITING
O'fallon
Illinois CancerCare-Ottawa Clinic
RECRUITING
Ottawa
Illinois CancerCare-Pekin
RECRUITING
Pekin
Illinois CancerCare-Peoria
RECRUITING
Peoria
Illinois CancerCare-Peru
RECRUITING
Peru
Illinois CancerCare-Princeton
RECRUITING
Princeton
Southern Illinois University School of Medicine
RECRUITING
Springfield
Springfield Clinic
RECRUITING
Springfield
Springfield Memorial Hospital
RECRUITING
Springfield
Carle Cancer Center
RECRUITING
Urbana
Illinois CancerCare - Washington
RECRUITING
Washington
Kentucky
University of Kentucky/Markey Cancer Center
RECRUITING
Lexington
Maine
Lafayette Family Cancer Center-EMMC
RECRUITING
Brewer
Michigan
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
RECRUITING
Ann Arbor
Trinity Health IHA Medical Group Hematology Oncology - Brighton
RECRUITING
Brighton
Trinity Health IHA Medical Group Hematology Oncology - Canton
RECRUITING
Canton
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
RECRUITING
Chelsea
Cancer Hematology Centers - Flint
RECRUITING
Flint
Genesee Hematology Oncology PC
RECRUITING
Flint
Genesys Hurley Cancer Institute
RECRUITING
Flint
Hurley Medical Center
RECRUITING
Flint
University of Michigan Health - Sparrow Lansing
RECRUITING
Lansing
Trinity Health Saint Mary Mercy Livonia Hospital
RECRUITING
Livonia
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
RECRUITING
Ypsilanti
Missouri
Saint Francis Medical Center
RECRUITING
Cape Girardeau
Parkland Health Center - Farmington
RECRUITING
Farmington
Sainte Genevieve County Memorial Hospital
RECRUITING
Sainte Genevieve
Missouri Baptist Sullivan Hospital
RECRUITING
Sullivan
BJC Outpatient Center at Sunset Hills
RECRUITING
Sunset Hills
Mississippi
Baptist Memorial Hospital and Cancer Center-Golden Triangle
RECRUITING
Columbus
Baptist Cancer Center-Grenada
RECRUITING
Grenada
Baptist Memorial Hospital and Cancer Center-Union County
RECRUITING
New Albany
Baptist Memorial Hospital and Cancer Center-Oxford
RECRUITING
Oxford
Baptist Memorial Hospital and Cancer Center-Desoto
RECRUITING
Southhaven
Montana
Billings Clinic Cancer Center
RECRUITING
Billings
Bozeman Health Deaconess Hospital
RECRUITING
Bozeman
Benefis Sletten Cancer Institute
RECRUITING
Great Falls
Community Medical Center
RECRUITING
Missoula
New Hampshire
New Hampshire Oncology Hematology PA-Concord
RECRUITING
Concord
Solinsky Center for Cancer Care
RECRUITING
Manchester
Nevada
OptumCare Cancer Care at Seven Hills
RECRUITING
Henderson
OptumCare Cancer Care at Charleston
RECRUITING
Las Vegas
OptumCare Cancer Care at Fort Apache
RECRUITING
Las Vegas
Ohio
ProMedica Flower Hospital
RECRUITING
Sylvania
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Oregon
Providence Newberg Medical Center
RECRUITING
Newberg
Saint Alphonsus Cancer Care Center-Ontario
RECRUITING
Ontario
Providence Willamette Falls Medical Center
RECRUITING
Oregon City
Providence Portland Medical Center
RECRUITING
Portland
Providence Saint Vincent Medical Center
RECRUITING
Portland
Pennsylvania
WellSpan Medical Oncology and Hematology
RECRUITING
Chambersburg
Ephrata Cancer Center
RECRUITING
Ephrata
Adams Cancer Center
RECRUITING
Gettysburg
Sechler Family Cancer Center
RECRUITING
Lebanon
Cancer Care Associates of York
RECRUITING
York
Tennessee
Baptist Memorial Hospital and Cancer Center-Collierville
RECRUITING
Collierville
Baptist Memorial Hospital and Cancer Center-Memphis
RECRUITING
Memphis
West Virginia
Edwards Comprehensive Cancer Center
RECRUITING
Huntington
West Virginia University Healthcare
RECRUITING
Morgantown
Time Frame
Start Date: 2024-11-19
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 88
Treatments
Experimental: Treatment (amivantamab)
Patients receive amivantamab 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 CT or MRI and collection of blood samples throughout the trial.
Sponsors
Leads: SWOG Cancer Research Network
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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