A Randomized Phase II Study of Tepotinib With or Without Ramucirumab in Participants With MET Exon 14 Skipping Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP SUB-STUDY)

Status: Recruiting
Location: See all (240) locations...
Intervention Type: Procedure, Biological, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This phase II Expanded Lung-MAP treatment trial tests tepotinib with or without ramucirumab for the treatment of patients with advanced non-small cell lung cancer that has spread from where it first started (primary site) to other places in the body (stage IV) or that has come back after a period of improvement (recurrent). Tepotinib is used in patients whose cancer has a mutated (changed) form of a gene called MET. It is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal MET protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving tepotinib with ramucirumab may lower the chance of the cancer from growing or spreading in patients with stage IV or recurrent non-small cell lung cancer.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Participants must have been assigned to S1900K by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1900K is determined by the LUNGMAP protocol

• Participants must have documentation of NSCLC with a MET exon 14 skipping mutation determined by tissue-based or blood-based (circulating tumor DNA \[ctDNA\]) next generation sequencing (NGS) assay done within a laboratory with Clinical Laboratory Improvement Act (CLIA), International Organization for Standardization (ISO)/ International Electrotechnical Commission (IEC), College of American Pathologists (CAP), or similar certification. Documentation must either be:

‣ NGS test results from tissue submitted for LUNGMAP screening, or

⁃ Submitted documentation in the LUNGMAP Rave Electronic Data Capture System of a MET exon 14 skipping mutation from a previously completed tissue or blood-based NGS test NOTE: Participants previously tested for and determined to have a MET exon 14 skipping mutation, outside of LUNGMAP, must also submit tissue for central Foundation Medicine (FMI) testing on the LUNGMAP screening protocol, if available

• 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 randomization. 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 randomization. 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 randomization 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 randomization

• Participants must not have leptomeningeal disease, spinal cord compression or brain metastases unless:

‣ Metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 3 days following the stereotactic radiation and/or 14 days following whole brain radiation, and prior to sub-study randomization, AND

⁃ Participant has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to sub-study randomization

• Participants must not have other known actionable oncogenic alterations, such as (but not limited to) EGFR sensitizing mutations, EGFR T790M mutation, 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 except alopecia and vitiligo

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

• Participants must not have received treatment with prior MET inhibitor therapies (e.g., crizotinib, tivantinib, savolitinib, tepotinib, cabozantinib, and foretinib).

• Participants must not have received treatment with prior angiogenesis inhibitor therapies (including but not limited to bevacizumab and ramucirumab)

• Participants must not have a history of interstitial lung disease that required steroid treatment

• Participants must not have received any radiation therapy within 7 days prior to sub-study randomization with the exceptions of

‣ Stereotactic radiation to CNS metastases which must have been completed at least 3 days prior to sub-study randomization and

⁃ Palliative radiotherapy to bone metastases which must have been completed at least 1 day prior to sub-study randomization

• 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 a major surgery within 14 days prior to sub-study randomization. Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator

• 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

• Participants must be able to swallow tablets whole

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

• Hemoglobin \>= 9.0 g/dL (within 28 days prior to sub-study randomization)

• Platelets \>= 100 x 10\^3/uL (within 28 days prior to sub-study randomization)

• 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 randomization)

• Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) =\< 2.5 × institutional ULN. Participants with history of liver metastasis must have AST =\< 5 x ULN (within 28 days prior to sub-study randomization)

• Participants must have a serum creatinine =\< the institutional upper limit of normal (IULN) or calculated creatinine clearance \>= 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to sub-study randomization

• Participants must have a cystatin C test performed to obtain baseline value within 28 days prior to sub-study randomization

• Participants' most recent Zubrod performance status must be 0-1 and be documented within 28 days prior to sub-study randomization

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

• Participants must have adequate cardiac function. 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 randomization

• 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 randomization, if indicated

• 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 randomization, if indicated by the treating investigator

• Participants must not have cirrhosis at a level of Child-Pugh B (or worse) OR any degree of cirrhosis AND a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis

• Participants must not have grade \< 0 of peripheral edema within 28 days prior to sub-study randomization

• Participants must not have experienced any arterial thromboembolic events, including but not limited to transient ischemic attack or cerebrovascular accident within 6 months prior to sub-study randomization

• Participants must not have uncontrolled blood pressure and hypertension within 28 days prior to sub-study randomization

• 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 have a Lymphoscintigraphy scan performed within 28 days prior to sub-study randomization

• 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

Locations
United States
Arkansas
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
RECRUITING
Jonesboro
University of Arkansas for Medical Sciences
RECRUITING
Little Rock
California
Kaiser Permanente-Anaheim
RECRUITING
Anaheim
Sutter Auburn Faith Hospital
RECRUITING
Auburn
Kaiser Permanente-Baldwin Park
RECRUITING
Baldwin Park
Kaiser Permanente-Bellflower
RECRUITING
Bellflower
Alta Bates Summit Medical Center-Herrick Campus
RECRUITING
Berkeley
Tower Cancer Research Foundation
RECRUITING
Beverly Hills
Kaiser Permanente-Fontana
RECRUITING
Fontana
Palo Alto Medical Foundation-Fremont
RECRUITING
Fremont
Kaiser Permanente South Bay
RECRUITING
Harbor City
Kaiser Permanente-Irvine
RECRUITING
Irvine
Cedars Sinai Medical Center
RECRUITING
Los Angeles
Kaiser Permanente Los Angeles Medical Center
RECRUITING
Los Angeles
Kaiser Permanente West Los Angeles
RECRUITING
Los Angeles
Memorial Medical Center
RECRUITING
Modesto
Kaiser Permanente-Ontario
RECRUITING
Ontario
Palo Alto Medical Foundation Health Care
RECRUITING
Palo Alto
Kaiser Permanente - Panorama City
RECRUITING
Panorama City
Kaiser Permanente-Riverside
RECRUITING
Riverside
Sutter Roseville Medical Center
RECRUITING
Roseville
Sutter Medical Center Sacramento
RECRUITING
Sacramento
University of California Davis Comprehensive Cancer Center
RECRUITING
Sacramento
Kaiser Permanente-San Diego Zion
RECRUITING
San Diego
California Pacific Medical Center-Pacific Campus
RECRUITING
San Francisco
Kaiser Permanente-San Marcos
RECRUITING
San Marcos
Palo Alto Medical Foundation-Santa Cruz
RECRUITING
Santa Cruz
Sutter Pacific Medical Foundation
RECRUITING
Santa Rosa
Palo Alto Medical Foundation-Sunnyvale
RECRUITING
Sunnyvale
Cedars-Sinai Cancer - Tarzana
RECRUITING
Tarzana
Torrance Memorial Physician Network - Cancer Care
RECRUITING
Torrance
Sutter Solano Medical Center/Cancer Center
RECRUITING
Vallejo
Kaiser Permanente-Woodland Hills
RECRUITING
Woodland Hills
Colorado
UCHealth University of Colorado Hospital
RECRUITING
Aurora
Memorial Hospital North
RECRUITING
Colorado Springs
UCHealth Memorial Hospital Central
RECRUITING
Colorado Springs
Cancer Care and Hematology-Fort Collins
RECRUITING
Fort Collins
Poudre Valley Hospital
RECRUITING
Fort Collins
UCHealth Greeley Hospital
RECRUITING
Greeley
Medical Center of the Rockies
RECRUITING
Loveland
Connecticut
Smilow Cancer Hospital-Derby Care Center
RECRUITING
Derby
Smilow Cancer Hospital Care Center-Fairfield
RECRUITING
Fairfield
Smilow Cancer Hospital Care Center at Glastonbury
RECRUITING
Glastonbury
Smilow Cancer Hospital Care Center at Greenwich
RECRUITING
Greenwich
Smilow Cancer Hospital Care Center - Guilford
RECRUITING
Guilford
Smilow Cancer Hospital Care Center at Saint Francis
RECRUITING
Hartford
Yale University
RECRUITING
New Haven
Yale-New Haven Hospital North Haven Medical Center
RECRUITING
North Haven
Smilow Cancer Hospital Care Center at Long Ridge
RECRUITING
Stamford
Smilow Cancer Hospital-Torrington Care Center
RECRUITING
Torrington
Smilow Cancer Hospital Care Center-Trumbull
RECRUITING
Trumbull
Smilow Cancer Hospital-Waterbury Care Center
RECRUITING
Waterbury
Smilow Cancer Hospital Care Center - Waterford
RECRUITING
Waterford
Washington, D.c.
Kaiser Permanente-Capitol Hill Medical Center
RECRUITING
Washington D.c.
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
Mission Cancer and Blood - Ankeny
RECRUITING
Ankeny
McFarland Clinic - Boone
RECRUITING
Boone
Iowa Methodist Medical Center
RECRUITING
Des Moines
Mission Cancer and Blood - Des Moines
RECRUITING
Des Moines
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
John H Stroger Jr Hospital of Cook County
RECRUITING
Chicago
Northwestern University
RECRUITING
Chicago
Carle at The Riverfront
RECRUITING
Danville
Cancer Care Specialists of Illinois - Decatur
RECRUITING
Decatur
Decatur Memorial Hospital
RECRUITING
Decatur
Northwestern Medicine Cancer Center Kishwaukee
RECRUITING
Dekalb
Illinois CancerCare-Dixon
RECRUITING
Dixon
Carle Physician Group-Effingham
RECRUITING
Effingham
Crossroads Cancer Center
RECRUITING
Effingham
Illinois CancerCare-Eureka
RECRUITING
Eureka
Illinois CancerCare-Galesburg
RECRUITING
Galesburg
Northwestern Medicine Cancer Center Delnor
RECRUITING
Geneva
Northwestern Medicine Glenview Outpatient Center
RECRUITING
Glenview
Northwestern Medicine Grayslake Outpatient Center
RECRUITING
Grayslake
Edward Hines Jr VA Hospital
RECRUITING
Hines
Illinois CancerCare-Kewanee Clinic
RECRUITING
Kewanee
Northwestern Medicine Lake Forest Hospital
RECRUITING
Lake Forest
Illinois CancerCare-Macomb
RECRUITING
Macomb
Carle Physician Group-Mattoon/Charleston
RECRUITING
Mattoon
Cancer Care Center of O'Fallon
RECRUITING
O'fallon
Northwestern Medicine Orland Park
RECRUITING
Orland Park
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
Memorial Hospital East
RECRUITING
Shiloh
Southern Illinois University School of Medicine
RECRUITING
Springfield
Springfield Clinic
RECRUITING
Springfield
Springfield Memorial Hospital
RECRUITING
Springfield
Carle Cancer Center
RECRUITING
Urbana
Northwestern Medicine Cancer Center Warrenville
RECRUITING
Warrenville
Illinois CancerCare - Washington
RECRUITING
Washington
Indiana
Indiana University/Melvin and Bren Simon Cancer Center
RECRUITING
Indianapolis
Kansas
University of Kansas Clinical Research Center
RECRUITING
Fairway
HaysMed
RECRUITING
Hays
University of Kansas Cancer Center
RECRUITING
Kansas City
Lawrence Memorial Hospital
RECRUITING
Lawrence
The University of Kansas Cancer Center - Olathe
RECRUITING
Olathe
University of Kansas Cancer Center-Overland Park
RECRUITING
Overland Park
University of Kansas Hospital-Indian Creek Campus
RECRUITING
Overland Park
Salina Regional Health Center
RECRUITING
Salina
University of Kansas Health System Saint Francis Campus
RECRUITING
Topeka
University of Kansas Hospital-Westwood Cancer Center
RECRUITING
Westwood
Kentucky
University of Kentucky/Markey Cancer Center
RECRUITING
Lexington
Massachusetts
UMass Memorial Medical Center - University Campus
RECRUITING
Worcester
Maryland
Kaiser Permanente-Woodlawn Medical Center
RECRUITING
Baltimore
Kaiser Permanente-Gaithersburg Medical Center
RECRUITING
Gaithersburg
Kaiser Permanente - Largo Medical Center
RECRUITING
Largo
Kaiser Permanente Lutherville - Timonium Medical Center
RECRUITING
Lutherville
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 Medical Center - Brighton
RECRUITING
Brighton
Trinity Health IHA Medical Group Hematology Oncology - Canton
RECRUITING
Canton
Trinity Health Medical Center - Canton
RECRUITING
Canton
Chelsea Hospital
RECRUITING
Chelsea
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
MyMichigan Medical Center Saginaw
RECRUITING
Saginaw
Oncology Hematology Associates of Saginaw Valley PC
RECRUITING
Saginaw
MyMichigan Medical Center Tawas
RECRUITING
Tawas City
Saint Mary's Oncology/Hematology Associates of West Branch
RECRUITING
West Branch
Huron Gastroenterology PC
RECRUITING
Ypsilanti
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
RECRUITING
Ypsilanti
Minnesota
Sanford Joe Lueken Cancer Center
RECRUITING
Bemidji
Essentia Health - Deer River Clinic
RECRUITING
Deer River
Essentia Health Cancer Center
RECRUITING
Duluth
Essentia Health Hibbing Clinic
RECRUITING
Hibbing
Essentia Health Sandstone
RECRUITING
Sandstone
Essentia Health Virginia Clinic
RECRUITING
Virginia
Missouri
Saint Francis Medical Center
RECRUITING
Cape Girardeau
Siteman Cancer Center at Saint Peters Hospital
RECRUITING
City Of Saint Peters
Siteman Cancer Center at West County Hospital
RECRUITING
Creve Coeur
Saint Luke's Hospital of Kansas City
ACTIVE_NOT_RECRUITING
Kansas City
University Health Truman Medical Center
RECRUITING
Kansas City
University of Kansas Cancer Center - North
RECRUITING
Kansas City
Saint Luke's East - Lee's Summit
ACTIVE_NOT_RECRUITING
Lee's Summit
University of Kansas Cancer Center - Lee's Summit
RECRUITING
Lee's Summit
University of Kansas Cancer Center at North Kansas City Hospital
RECRUITING
North Kansas City
Siteman Cancer Center at Christian Hospital
RECRUITING
St Louis
Siteman Cancer Center-South County
RECRUITING
St Louis
Washington University School of Medicine
RECRUITING
St Louis
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
Community Hospital of Anaconda
RECRUITING
Anaconda
Billings Clinic Cancer Center
RECRUITING
Billings
Bozeman Health Deaconess Hospital
RECRUITING
Bozeman
Benefis Sletten Cancer Institute
RECRUITING
Great Falls
Logan Health Medical Center
RECRUITING
Kalispell
Community Medical Center
RECRUITING
Missoula
North Dakota
Sanford Bismarck Medical Center
RECRUITING
Bismarck
Sanford Broadway Medical Center
RECRUITING
Fargo
Sanford Roger Maris Cancer Center
RECRUITING
Fargo
New Hampshire
New Hampshire Oncology Hematology PA-Concord
RECRUITING
Concord
Solinsky Center for Cancer Care
RECRUITING
Manchester
New Jersey
Memorial Sloan Kettering Basking Ridge
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth
RECRUITING
Middletown
Memorial Sloan Kettering Bergen
RECRUITING
Montvale
Virtua Samson Cancer Center
RECRUITING
Moorestown
Virtua Voorhees
RECRUITING
Voorhees Township
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
New York
Memorial Sloan Kettering Commack
RECRUITING
Commack
Mary Imogene Bassett Hospital
RECRUITING
Cooperstown
Memorial Sloan Kettering Westchester
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
University of Rochester
RECRUITING
Rochester
Memorial Sloan Kettering Nassau
RECRUITING
Uniondale
Ohio
Aultman Health Foundation
RECRUITING
Canton
Miami Valley Hospital South
RECRUITING
Centerville
Miami Valley Hospital
RECRUITING
Dayton
Miami Valley Hospital North
RECRUITING
Dayton
Premier Blood and Cancer Center
RECRUITING
Dayton
Atrium Medical Center-Middletown Regional Hospital
RECRUITING
Franklin
Miami Valley Cancer Care and Infusion
RECRUITING
Greenville
ProMedica Flower Hospital
RECRUITING
Sylvania
Upper Valley Medical Center
RECRUITING
Troy
Oklahoma
Cancer Centers of Southwest Oklahoma Research
RECRUITING
Lawton
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
Oregon Health and Science University
RECRUITING
Portland
Providence Portland Medical Center
RECRUITING
Portland
Providence Saint Vincent Medical Center
RECRUITING
Portland
Pennsylvania
WellSpan Medical Oncology and Hematology
RECRUITING
Chambersburg
Geisinger Medical Center
RECRUITING
Danville
Ephrata Cancer Center
RECRUITING
Ephrata
Adams Cancer Center
RECRUITING
Gettysburg
Sechler Family Cancer Center
RECRUITING
Lebanon
Geisinger Medical Oncology-Lewisburg
RECRUITING
Lewisburg
Community Medical Center
RECRUITING
Scranton
Geisinger Wyoming Valley/Henry Cancer Center
RECRUITING
Wilkes-barre
Cancer Care Associates of York
RECRUITING
York
WellSpan Health-York Cancer Center
RECRUITING
York
WellSpan Health-York Hospital
RECRUITING
York
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
South Dakota
Sanford Cancer Center Oncology Clinic
RECRUITING
Sioux Falls
Sanford USD Medical Center - Sioux Falls
RECRUITING
Sioux Falls
Tennessee
Baptist Memorial Hospital and Cancer Center-Collierville
RECRUITING
Collierville
Baptist Memorial Hospital and Cancer Center-Memphis
RECRUITING
Memphis
Texas
The Don and Sybil Harrington Cancer Center
RECRUITING
Amarillo
Virginia
Kaiser Permanente Tysons Corner Medical Center
RECRUITING
Mclean
Kaiser Permanente-Caton Hill Medical Center
RECRUITING
Woodbridge
Washington
Swedish Cancer Institute-Edmonds
RECRUITING
Edmonds
Swedish Cancer Institute-Issaquah
RECRUITING
Issaquah
Swedish Medical Center-First Hill
RECRUITING
Seattle
Wisconsin
Duluth Clinic Ashland
RECRUITING
Ashland
Marshfield Medical Center-EC Cancer Center
RECRUITING
Eau Claire
Gundersen Lutheran Medical Center
RECRUITING
La Crosse
Marshfield Medical Center-Marshfield
RECRUITING
Marshfield
Marshfield Medical Center - Minocqua
RECRUITING
Minocqua
Marshfield Medical Center-River Region at Stevens Point
RECRUITING
Stevens Point
Marshfield Medical Center - Weston
RECRUITING
Weston
West Virginia
Edwards Comprehensive Cancer Center
RECRUITING
Huntington
Contact Information
Primary
Jennifer Beeler
jbeeler@swog.org
2106148808
Backup
SWOG P Department
protocols@swog.org
2106148808
Time Frame
Start Date: 2024-08-08
Estimated Completion Date: 2029-05-31
Participants
Target number of participants: 56
Treatments
Experimental: Arm A: (Ramucirumab and tepotinib)
Patients receive ramucirumab IV over 30-60 minutes on day 1 of each cycle and tepotinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo lymphoscintigraphy scan and CT scan and/or MRI throughout the trial. Patients also undergo blood sample collection while on study.
Active_comparator: Arm B: (Tepotinib)
Patients receive tepotinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo lymphoscintigraphy scan and CT scan and/or MRI throughout the trial. Patients also undergo blood sample collection while on study.
Sponsors
Collaborators: Eli Lilly and Company, EMD Serono, National Cancer Institute (NCI)
Leads: SWOG Cancer Research Network

This content was sourced from clinicaltrials.gov

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