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Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has Increased Copies of the MET Gene (An Expanded Lung-MAP Treatment Trial)

RecruitingPhase 2

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)

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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

About the 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.

What is being tested

Sponsor: SWOG Cancer Research Network · Participants: 88 · Started: Nov 19, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06116682

Locations in the U.S.

ArkansasNEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro, Jonesboro
University of Arkansas for Medical Sciences, Little Rock
CaliforniaSutter Auburn Faith Hospital, Auburn
Alta Bates Summit Medical Center-Herrick Campus, Berkeley
Palo Alto Medical Foundation-Fremont, Fremont
UC San Diego Moores Cancer Center, La Jolla
Loma Linda University Medical Center, Loma Linda
Memorial Medical Center, Modesto
Eisenhower Medical Center, Rancho Mirage
Sutter Roseville Medical Center, Roseville
Sutter Medical Center Sacramento, Sacramento
University of California Davis Comprehensive Cancer Center, Sacramento
California Pacific Medical Center-Pacific Campus, San Francisco
Mills Health Center, San Mateo
Sutter Pacific Medical Foundation, Santa Rosa
Palo Alto Medical Foundation-Sunnyvale, Sunnyvale
Sutter Solano Medical Center/Cancer Center, Vallejo
ColoradoRocky Mountain Regional VA Medical Center, Aurora
Memorial Hospital North, Colorado Springs
UCHealth Memorial Hospital Central, Colorado Springs
Cancer Care and Hematology-Fort Collins, Fort Collins
Poudre Valley Hospital, Fort Collins
UCHealth Greeley Hospital, Greeley
Medical Center of the Rockies, Loveland
ConnecticutSmilow Cancer Hospital-Derby Care Center, Derby
Smilow Cancer Hospital Care Center-Fairfield, Fairfield
Smilow Cancer Hospital Care Center - Guilford, Guilford
Yale University, New Haven
Yale-New Haven Hospital North Haven Medical Center, North Haven
Smilow Cancer Hospital Care Center-Trumbull, Trumbull
Smilow Cancer Hospital-Waterbury Care Center, Waterbury
DelawareBayhealth Hospital Kent Campus, Dover
Bayhealth Hospital Sussex Campus, Milford
FloridaMalcom Randall Veterans Administration Medical Center, Gainesville
GeorgiaNortheast Georgia Medical Center-Gainesville, Gainesville
HawaiiHawaii Cancer Care Inc - Waterfront Plaza, Honolulu
Kapiolani Medical Center for Women and Children, Honolulu
Queen's Cancer Cenrer - POB I, Honolulu
Queen's Cancer Center - Kuakini, Honolulu
Queen's Medical Center, Honolulu
Straub Clinic and Hospital, Honolulu
Hawaii Cancer Care - Westridge, ‘Aiea
Pali Momi Medical Center, ‘Aiea
The Queen's Medical Center - West Oahu, ‘Ewa Beach
IdahoSaint Alphonsus Cancer Care Center-Boise, Boise
Saint Alphonsus Cancer Care Center-Caldwell, Caldwell
Kootenai Health - Coeur d'Alene, Coeur d'Alene
Saint Alphonsus Cancer Care Center-Nampa, Nampa
Kootenai Clinic Cancer Services - Post Falls, Post Falls
Kootenai Clinic Cancer Services - Sandpoint, Sandpoint
IllinoisAdvocate Outpatient Center - Aurora, Aurora
Advocate Good Shepherd Hospital, Barrington
Illinois CancerCare-Bloomington, Bloomington
Illinois CancerCare-Canton, Canton
Illinois CancerCare-Carthage, Carthage
Advocate Illinois Masonic Medical Center, Chicago
Northwestern University, Chicago
AMG Crystal Lake - Oncology, Crystal Lake
Carle at The Riverfront, Danville
Northwestern Medicine Cancer Center Kishwaukee, DeKalb
Cancer Care Specialists of Illinois - Decatur, Decatur
Decatur Memorial Hospital, Decatur
Illinois CancerCare-Dixon, Dixon
Advocate Good Samaritan Hospital, Downers Grove
Carle Physician Group-Effingham, Effingham
Crossroads Cancer Center, Effingham
Advocate Sherman Hospital, Elgin
Illinois CancerCare-Eureka, Eureka
Illinois CancerCare-Galesburg, Galesburg
Northwestern Medicine Cancer Center Delnor, Geneva
Northwestern Medicine Glenview Outpatient Center, Glenview
Northwestern Medicine Grayslake Outpatient Center, Grayslake
Advocate South Suburban Hospital, Hazel Crest
Edward Hines Jr VA Hospital, Hines
Illinois CancerCare-Kewanee Clinic, Kewanee
Northwestern Medicine Lake Forest Hospital, Lake Forest
AMG Libertyville - Oncology, Libertyville
Condell Memorial Hospital, Libertyville
Illinois CancerCare-Macomb, Macomb
Carle Physician Group-Mattoon/Charleston, Mattoon
Loyola University Medical Center, Maywood
Cancer Care Center of O'Fallon, O'Fallon
Northwestern Medicine Oak Brook, Oak Brook
Advocate Christ Medical Center, Oak Lawn
Advocate Outpatient Center - Oak Lawn, Oak Lawn
Northwestern Medicine Orland Park, Orland Park
Illinois CancerCare-Ottawa Clinic, Ottawa
Advocate High Tech Medical Park, Palos Heights
Advocate Lutheran General Hospital, Park Ridge
Illinois CancerCare-Pekin, Pekin
Illinois CancerCare-Peoria, Peoria
Illinois CancerCare-Peru, Peru
Illinois CancerCare-Princeton, Princeton
Southern Illinois University School of Medicine, Springfield
Springfield Clinic, Springfield
Springfield Memorial Hospital, Springfield
Carle Cancer Center, Urbana
Northwestern Medicine Cancer Center Warrenville, Warrenville
Illinois CancerCare - Washington, Washington
IndianaIndiana University/Melvin and Bren Simon Cancer Center, Indianapolis
IowaMary Greeley Medical Center, Ames
McFarland Clinic - Ames, Ames
McFarland Clinic - Trinity Cancer Center, Fort Dodge
McFarland Clinic - Marshalltown, Marshalltown
KansasUniversity of Kansas Clinical Research Center, Fairway
HaysMed, Hays
University of Kansas Cancer Center, Kansas City
Lawrence Memorial Hospital, Lawrence
The University of Kansas Cancer Center - Olathe, Olathe
University of Kansas Cancer Center-Overland Park, Overland Park
University of Kansas Hospital-Indian Creek Campus, Overland Park
Salina Regional Health Center, Salina
University of Kansas Health System Saint Francis Campus, Topeka
University of Kansas Hospital-Westwood Cancer Center, Westwood
KentuckyUniversity of Kentucky/Markey Cancer Center, Lexington
MaineLafayette Family Cancer Center-EMMC, Brewer
MassachusettsBeverly Hospital, Beverly
Lahey Hospital and Medical Center, Burlington
Addison Gilbert Hospital, Gloucester
Lahey Medical Center-Peabody, Peabody
Baystate Medical Center, Springfield
UMass Memorial Medical Center - University Campus, Worcester
MichiganTrinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor
Bronson Battle Creek, Battle Creek
Trinity Health IHA Medical Group Hematology Oncology - Brighton, Brighton
Henry Ford Cancer Institute-Downriver, Brownstown
Trinity Health IHA Medical Group Hematology Oncology - Canton, Canton
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital, Chelsea
Henry Ford Macomb Hospital-Clinton Township, Clinton Township
Henry Ford Medical Center-Fairlane, Dearborn
Henry Ford Hospital, Detroit
Cancer Hematology Centers - Flint, Flint
Genesys Hurley Cancer Institute, Flint
Hurley Medical Center, Flint
Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids
Allegiance Health, Jackson
Bronson Methodist Hospital, Kalamazoo
West Michigan Cancer Center, Kalamazoo
University of Michigan Health - Sparrow Lansing, Lansing
Trinity Health Saint Mary Mercy Livonia Hospital, Livonia
Trinity Health Muskegon Hospital, Muskegon
Corewell Health Lakeland Hospitals - Niles Hospital, Niles
Cancer and Hematology Centers of Western Michigan - Norton Shores, Norton Shores
Henry Ford Medical Center-Columbus, Novi
Trinity Health Saint Joseph Mercy Oakland Hospital, Pontiac
Corewell Health Reed City Hospital, Reed City
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center, Saint Joseph
Munson Medical Center, Traverse City
Henry Ford West Bloomfield Hospital, West Bloomfield
Henry Ford Wyandotte Hospital, Wyandotte
University of Michigan Health - West, Wyoming
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus, Ypsilanti
MinnesotaEssentia Health - Deer River Clinic, Deer River
Essentia Health Cancer Center, Duluth
Essentia Health Hibbing Clinic, Hibbing
Essentia Health Sandstone, Sandstone
Essentia Health Virginia Clinic, Virginia
MississippiBaptist Memorial Hospital and Cancer Center-Golden Triangle, Columbus
Baptist Cancer Center-Grenada, Grenada
Baptist Memorial Hospital and Cancer Center-Union County, New Albany
Baptist Memorial Hospital and Cancer Center-Oxford, Oxford
Baptist Memorial Hospital and Cancer Center-Desoto, Southhaven
MissouriSaint Francis Medical Center, Cape Girardeau
Parkland Health Center - Farmington, Farmington
University Health Truman Medical Center, Kansas City
University of Kansas Cancer Center - Briarcliff, Kansas City
University of Kansas Cancer Center - North, Kansas City
University of Kansas Cancer Center - Lee's Summit, Lee's Summit
Sainte Genevieve County Memorial Hospital, Sainte Genevieve
Mercy Hospital South, St Louis
Missouri Baptist Medical Center, St Louis
Missouri Baptist Sullivan Hospital, Sullivan
BJC Outpatient Center at Sunset Hills, Sunset Hills
MontanaCommunity Hospital of Anaconda, Anaconda
Billings Clinic Cancer Center, Billings
Bozeman Health Deaconess Hospital, Bozeman
Benefis Sletten Cancer Institute, Great Falls
Logan Health Medical Center, Kalispell
Community Medical Center, Missoula
NevadaOptumCare Cancer Care at Charleston, Las Vegas
OptumCare Cancer Care at Fort Apache, Las Vegas
New HampshireNew Hampshire Oncology Hematology PA-Concord, Concord
Solinsky Center for Cancer Care, Manchester
New JerseyVirtua Samson Cancer Center, Moorestown
Virtua Voorhees, Voorhees Township
OhioAultman Health Foundation, Canton
Ohio State University Comprehensive Cancer Center, Columbus
ProMedica Flower Hospital, Sylvania
OklahomaCancer Centers of Southwest Oklahoma Research, Lawton
University of Oklahoma Health Sciences Center, Oklahoma City
OregonProvidence Newberg Medical Center, Newberg
Saint Alphonsus Cancer Care Center-Ontario, Ontario
Providence Willamette Falls Medical Center, Oregon City
Kaiser Permanente Northwest, Portland
Oregon Health and Science University, Portland
Providence Portland Medical Center, Portland
Providence Saint Vincent Medical Center, Portland
PennsylvaniaWellSpan Medical Oncology and Hematology, Chambersburg
Geisinger Medical Center, Danville
Geisinger Cancer Center Dickson City, Dickson City
Ephrata Cancer Center, Ephrata
Adams Cancer Center, Gettysburg
Sechler Family Cancer Center, Lebanon
Geisinger Medical Oncology-Lewisburg, Lewisburg
Community Medical Center, Scranton
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre
Cancer Care Associates of York, York
WellSpan Health-York Cancer Center, York
South CarolinaRalph H Johnson VA Medical Center, Charleston
TennesseeBaptist Memorial Hospital and Cancer Center-Collierville, Collierville
Baptist Memorial Hospital and Cancer Center-Memphis, Memphis
UtahHuntsman Cancer Institute/University of Utah, Salt Lake City
VirginiaUniversity of Virginia Cancer Center, Charlottesville
VCU Massey Cancer Center at Stony Point, Richmond
VCU Massey Comprehensive Cancer Center, Richmond
Virginia Cancer Institute, Richmond
VCU Community Memorial Health Center, South Hill
WashingtonSwedish Cancer Institute-Edmonds, Edmonds
Swedish Cancer Institute-Issaquah, Issaquah
Swedish Medical Center-First Hill, Seattle
West VirginiaEdwards Comprehensive Cancer Center, Huntington
West Virginia University Healthcare, Morgantown
WisconsinDuluth Clinic Ashland, Ashland
Aurora Cancer Care-Southern Lakes VLCC, Burlington
Aurora Saint Luke's South Shore, Cudahy
Aurora Health Care Germantown Health Center, Germantown
Aurora Cancer Care-Grafton, Grafton
Aurora BayCare Medical Center, Green Bay
Aurora Cancer Care-Kenosha South, Kenosha
Gundersen Lutheran Medical Center, La Crosse
Aurora Bay Area Medical Group-Marinette, Marinette
Aurora Cancer Care-Milwaukee, Milwaukee
Aurora Saint Luke's Medical Center, Milwaukee
Aurora Sinai Medical Center, Milwaukee
Vince Lombardi Cancer Clinic - Oshkosh, Oshkosh
Aurora Cancer Care-Racine, Racine
Vince Lombardi Cancer Clinic-Sheboygan, Sheboygan
Marshfield Medical Center-River Region at Stevens Point, Stevens Point
Aurora Medical Center in Summit, Summit
Vince Lombardi Cancer Clinic-Two Rivers, Two Rivers
Aurora Cancer Care-Milwaukee West, Wauwatosa
Aurora West Allis Medical Center, West Allis
Marshfield Medical Center - Weston, Weston

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.