A Randomized Phase II/III Study of Docetaxel and Ramucirumab With or Without Cemiplimab for Participants Previously Treated With Platinum-Based Chemotherapy and Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study)

Status: Recruiting
Location: See all (239) locations...
Intervention Type: Procedure, Biological, Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

This phase II/III Expanded Lung-MAP treatment trial compares the effect of adding cemiplimab to docetaxel and ramucirumab versus docetaxel and ramucirumab alone in treating patients with non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Cemiplimab is a monoclonal antibody that stimulates the immune system by blocking the PD-1 pathway. Tumors use the PD-1 pathway to escape attacks from the immune system. By blocking the PD-1 pathway, cemiplimab may help the immune system recognize and attack tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Adding cemiplimab to usual treatment, docetaxel and ramucirumab, may kill more tumor cells compared to docetaxel and ramucirumab alone in treating patients with stage IV or recurrent non-small cell lung cancer.

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

• Participants must have been assigned to S1800E by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1800E is determined by the LUNGMAP protocol

• Participants must have measurable or non-measurable disease documented by CT or MRI. The CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality. Measurable disease must be assessed within 28 days prior to 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 randomization. All 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 registration

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

• Participants must have received exactly one anti-PD-1 or anti-PD-L1 therapy for advanced disease (stage IV or recurrent disease, or stage I-III disease in certain circumstances outlined below). Anti-PD-1 or anti-PD-L1 therapy may have been given alone or in combination with other therapy. For participants who received neoadjuvant, adjuvant, and/or consolidation anti-PD-1 or anti-PD-L1 therapy for stage I-III disease:

‣ If they experienced disease progression within (≤) 365 days from initiation (cycle 1 day 1) or anti-PD-1 or anti-PD-L1 therapy, this counts as the single allowed anti-PD-1 or anti-PD-L1 therapy for advanced disease

⁃ If they experienced disease progression more than (\>) 365 days from initiation (cycle 1 day 1) or anti-PD-1 or anti-PD-L1 therapy, this is not considered anti-PD-1 or anti-PD-L1 therapy for advance disease. These participants must have received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease

• Participants must have experienced disease progression (in the opinion of the treating investigator) more than (\>) 84 days following initiation (cycle 1 day 1) of their most recent anti-PD-1 or anti-PD-L1 therapy

• Participants who received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease must have had a best response of stable disease, partial response or complete response (in the opinion of the treating investigator) on the anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease

• Participants must have received platinum-based chemotherapy and experienced disease progression (in the opinion of the treating investigator) during or after this regimen

• Participants with a known sensitizing molecular alteration for which a Food and Drug Administration (FDA)-approved targeted therapy for NSCLC exists (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, KRAS, HER2, and MET sensitizing mutations), must have previously received at least one of the approved therapy(s). Prior targeted therapy for participants with targetable alterations is allowed if all other eligibility criteria are also met

• Participants must have recovered (≤ grade 1) from any side effects from the most recent anti-cancer treatment prior to randomization

• Participants must not have received prior therapy with docetaxel for this disease

• Participants must not have received any palliative radiation therapy within 14 days (or palliative bone radiation therapy within 7 days) prior to randomization

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

• Participants must not have undergone major surgery within 28 days prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization. Participants must not have postoperative bleeding complications or wound complications from a surgical procedure performed within 2 months prior to randomization. The participant must not have elective or planned major surgery to be performed during the course of this study

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

• Hemoglobin ≥ 9.0 g/dL (within 28 days prior to randomization)

• Platelets ≥ 100 x 10\^3/uL (within 28 days prior to randomization)

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

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

• Participants must have a creatinine ≤ the institutional (I)ULN or calculated creatinine clearance ≥ 50 mL/min using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 28 days prior to randomization

• Participants must have a urinary protein test performed within 28 days prior to randomization

• Participants' most recent Zubrod/Eastern Cooperative Oncology Group (ECOG) performance status must be 0-1 and be documented within 28 days prior to randomization

• Participants must have a completed medical history and physical exam within 28 days prior to 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 randomization, if indicated by the treating investigator

• 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 randomization, if indicated by the treating investigator

• Participants with known human immunodeficiency virus (HIV) infection are eligible, provided they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 6 months prior to randomization

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

• Participants must not have an active autoimmune disease that has required systemic treatment within 730 days prior to randomization (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed

• Participants must not have any history of primary immunodeficiency

• Participants must be able to safely receive study therapy and must not have experienced the following:

‣ Any grade 3 or worse immune-mediated adverse event. Exception: asymptomatic nonbullous/nonexfoliative rash

⁃ Any unresolved grade 2 immune-mediated adverse event

⁃ Any toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy

⁃ Exception to the above: Toxicities of any grade that requires replacement therapy and has stabilized on therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are allowed

• Participants must not have any history of organ transplant that requires use of immunosuppressives

• Participants must not have received a live or live attenuated vaccine within 28 days prior to randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever rabies, Bacillus Calmette-Guerin (BCG) and typhoid vaccine. Seasonal influenza vaccines and COVID-19 vaccines are allowed, however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated and are not allowed

• Participants must not have clinical signs or symptoms of active tuberculosis infection

• Participants must not have a history of (non-infectious) pneumonitis that required steroids or current pneumonitis/interstitial lung disease

• Participants must not have had a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization

• Participants must not have a history of gastrointestinal perforation or fistula within 6 months prior to randomization

• Participants must not have grade 3-4 gastrointestinal bleeding (defined by National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\]5) within 3 months prior to randomization. No history of gastrointestinal (GI) bleed within 3 months prior to randomization

• Participants must not have any grade III/IV cardiac disease as defined by the New York Heart Association criteria (i.e., participants with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months prior to randomization, or serious uncontrolled cardiac arrhythmia

• Participants must not have experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to randomization

• Participants must not have gross hemoptysis within two months prior to randomization (defined as bright red blood or ≥ 1/2 teaspoon) or with radiographic evidence of intratumor cavitation or has radiologically documented evidence of major blood vessel invasion or encasement by cancer

• Participants must not have been diagnosed with venous thrombosis within 3 months prior to randomization. Participants with venous thrombosis diagnosed more than 3 months prior to randomization must be on stable doses of anticoagulants

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

• 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 be offered participation in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG specimen tracking system

• NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the 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
Alaska
Katmai Oncology Group
RECRUITING
Anchorage
Arkansas
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
RECRUITING
Jonesboro
California
Kaiser Permanente-Anaheim
RECRUITING
Anaheim
Kaiser Permanente-Baldwin Park
RECRUITING
Baldwin Park
Kaiser Permanente-Bellflower
RECRUITING
Bellflower
Tower Cancer Research Foundation
RECRUITING
Beverly Hills
Kaiser Permanente-Fontana
RECRUITING
Fontana
Kaiser Permanente-Fresno
RECRUITING
Fresno
Kaiser Permanente South Bay
RECRUITING
Harbor City
Kaiser Permanente-Irvine
RECRUITING
Irvine
UC San Diego Moores Cancer Center
RECRUITING
La Jolla
Loma Linda University Medical Center
RECRUITING
Loma Linda
Cedars Sinai Medical Center
RECRUITING
Los Angeles
Kaiser Permanente Los Angeles Medical Center
RECRUITING
Los Angeles
Kaiser Permanente West Los Angeles
RECRUITING
Los Angeles
Fremont - Rideout Cancer Center
RECRUITING
Marysville
Mather Veteran Affairs Medical Center
RECRUITING
Mather
Kaiser Permanente-Oakland
RECRUITING
Oakland
Kaiser Permanente-Ontario
RECRUITING
Ontario
Kaiser Permanente - Panorama City
RECRUITING
Panorama City
Eisenhower Medical Center
RECRUITING
Rancho Mirage
Kaiser Permanente-Riverside
RECRUITING
Riverside
Kaiser Permanente-Roseville
RECRUITING
Roseville
Kaiser Permanente Downtown Commons
RECRUITING
Sacramento
University of California Davis Comprehensive Cancer Center
RECRUITING
Sacramento
Kaiser Permanente-San Diego Zion
RECRUITING
San Diego
Kaiser Permanente-San Francisco
RECRUITING
San Francisco
Kaiser Permanente-Santa Teresa-San Jose
RECRUITING
San Jose
Kaiser Permanente San Leandro
RECRUITING
San Leandro
Kaiser Permanente-San Marcos
RECRUITING
San Marcos
Mills Health Center
RECRUITING
San Mateo
Kaiser San Rafael-Gallinas
RECRUITING
San Rafael
Kaiser Permanente Medical Center - Santa Clara
RECRUITING
Santa Clara
Kaiser Permanente-South San Francisco
RECRUITING
South San Francisco
Cedars-Sinai Cancer - Tarzana
RECRUITING
Tarzana
Torrance Memorial Physician Network - Cancer Care
RECRUITING
Torrance
Gene Upshaw Memorial Tahoe Forest Cancer Center
RECRUITING
Truckee
Kaiser Permanente-Vallejo
RECRUITING
Vallejo
Kaiser Permanente-Walnut Creek
RECRUITING
Walnut Creek
Kaiser Permanente-Woodland Hills
RECRUITING
Woodland Hills
Connecticut
Yale University
RECRUITING
New Haven
Yale-New Haven Hospital North Haven Medical Center
RECRUITING
North Haven
Smilow Cancer Hospital-Waterbury Care Center
RECRUITING
Waterbury
Washington, D.c.
Kaiser Permanente-Capitol Hill Medical Center
RECRUITING
Washington D.c.
Florida
Malcom Randall Veterans Administration Medical Center
RECRUITING
Gainesville
Moffitt Cancer Center
RECRUITING
Tampa
Georgia
Emory Saint Joseph's Hospital
RECRUITING
Atlanta
Emory University Hospital Midtown
RECRUITING
Atlanta
Emory University Hospital/Winship Cancer Institute
RECRUITING
Atlanta
Emory Johns Creek Hospital
RECRUITING
Johns Creek
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
RECRUITING
Savannah
Idaho
Kootenai Health - Coeur d'Alene
RECRUITING
Coeur D'alene
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
Northwestern University
RECRUITING
Chicago
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
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
Illinois CancerCare-Kewanee Clinic
RECRUITING
Kewanee
Northwestern Medicine Lake Forest Hospital
RECRUITING
Lake Forest
Illinois CancerCare-Macomb
RECRUITING
Macomb
Loyola University Medical Center
RECRUITING
Maywood
Cancer Care Center of O'Fallon
RECRUITING
O'fallon
HSHS Saint Elizabeth's Hospital
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
Northwestern Medicine Cancer Center Warrenville
RECRUITING
Warrenville
Illinois CancerCare - Washington
RECRUITING
Washington
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
Lahey Hospital and Medical Center
RECRUITING
Burlington
Lahey Medical Center-Peabody
RECRUITING
Peabody
Maryland
Kaiser Permanente-Woodlawn Medical Center
RECRUITING
Baltimore
Saint Agnes Hospital
RECRUITING
Baltimore
UPMC Western Maryland
RECRUITING
Cumberland
Kaiser Permanente-Gaithersburg Medical Center
RECRUITING
Gaithersburg
Kaiser Permanente - Largo Medical Center
RECRUITING
Largo
Kaiser Permanente Lutherville - Timonium Medical Center
RECRUITING
Lutherville
Maine
Harold Alfond Center for Cancer Care
RECRUITING
Augusta
MaineHealth Waldo Hospital
RECRUITING
Belfast
Lafayette Family Cancer Center-EMMC
RECRUITING
Brewer
MaineHealth Cancer Care and IV Therapy - Brunswick
RECRUITING
Brunswick
Penobscot Bay Medical Center
RECRUITING
Rockport
MaineHealth Cancer Care Center of York County
RECRUITING
Sanford
MaineHealth Cancer Care and IV Therapy - South Portland
RECRUITING
South Portland
Michigan
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
University of Michigan Health - Sparrow Lansing
RECRUITING
Lansing
Trinity Health Saint Mary Mercy Livonia Hospital
RECRUITING
Livonia
Trinity Health Saint Joseph Mercy Oakland Hospital
RECRUITING
Pontiac
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
RECRUITING
Ypsilanti
Minnesota
Sanford Joe Lueken Cancer Center
RECRUITING
Bemidji
Essentia Health Saint Joseph's Medical Center
RECRUITING
Brainerd
Mercy Hospital
RECRUITING
Coon Rapids
Essentia Health - Deer River Clinic
RECRUITING
Deer River
Essentia Health Cancer Center
RECRUITING
Duluth
Fairview Southdale Hospital
RECRUITING
Edina
Essentia Health Hibbing Clinic
RECRUITING
Hibbing
Abbott-Northwestern Hospital
RECRUITING
Minneapolis
Park Nicollet Clinic - Saint Louis Park
RECRUITING
Saint Louis Park
Regions Hospital
RECRUITING
Saint Paul
United Hospital
RECRUITING
Saint Paul
Essentia Health Sandstone
RECRUITING
Sandstone
Essentia Health Virginia Clinic
RECRUITING
Virginia
Minnesota Oncology Hematology PA-Woodbury
RECRUITING
Woodbury
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
Parkland Health Center - Farmington
RECRUITING
Farmington
University Health Truman Medical Center
RECRUITING
Kansas City
University of Kansas Cancer Center - North
RECRUITING
Kansas City
University of Kansas Cancer Center - Lee's Summit
RECRUITING
Lee's Summit
Sainte Genevieve County Memorial Hospital
RECRUITING
Sainte Genevieve
Missouri Baptist Medical Center
RECRUITING
St Louis
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
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
Gulfport Memorial Hospital
RECRUITING
Gulfport
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
Benefis Sletten Cancer Institute
RECRUITING
Great Falls
Logan Health Medical Center
RECRUITING
Kalispell
Community Medical Center
RECRUITING
Missoula
North Carolina
Durham VA Medical Center
RECRUITING
Durham
FirstHealth of the Carolinas-Moore Regional Hospital
RECRUITING
Pinehurst
North Dakota
Sanford Bismarck Medical Center
RECRUITING
Bismarck
Essentia Health Cancer Center-South University Clinic
RECRUITING
Fargo
Sanford Broadway Medical Center
RECRUITING
Fargo
Sanford Roger Maris Cancer Center
RECRUITING
Fargo
New Hampshire
New Hampshire Oncology Hematology PA-Concord
RECRUITING
Concord
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
RECRUITING
Lebanon
Solinsky Center for Cancer Care
RECRUITING
Manchester
New Jersey
Virtua Samson Cancer Center
RECRUITING
Moorestown
Virtua Voorhees
RECRUITING
Voorhees Township
New Mexico
University of New Mexico Cancer Center
RECRUITING
Albuquerque
New York
University of Rochester
RECRUITING
Rochester
Wilmot Cancer Institute at Webster
RECRUITING
Webster
Ohio
Aultman Health Foundation
RECRUITING
Canton
ProMedica Flower Hospital
RECRUITING
Sylvania
Oklahoma
Cancer Centers of Southwest Oklahoma Research
RECRUITING
Lawton
Integris Southwest Medical Center
RECRUITING
Oklahoma City
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Oregon
Providence Newberg Medical Center
RECRUITING
Newberg
Providence Portland Medical Center
RECRUITING
Portland
Providence Saint Vincent Medical Center
RECRUITING
Portland
Salem Hospital
RECRUITING
Salem
Pennsylvania
UPMC-Heritage Valley Health System Beaver
RECRUITING
Beaver
UPMC Hillman Cancer Center at Butler Health System
RECRUITING
Butler
WellSpan Medical Oncology and Hematology
RECRUITING
Chambersburg
UPMC Hillman Cancer Center - Passavant - Cranberry
RECRUITING
Cranberry Township
Ephrata Cancer Center
RECRUITING
Ephrata
UPMC Hillman Cancer Center Erie
RECRUITING
Erie
UPMC Cancer Center at UPMC Horizon
RECRUITING
Farrell
Adams Cancer Center
RECRUITING
Gettysburg
UPMC Cancer Centers - Arnold Palmer Pavilion
RECRUITING
Greensburg
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
RECRUITING
Harrisburg
IRMC Cancer Center
RECRUITING
Indiana
UPMC-Johnstown/John P. Murtha Regional Cancer Center
RECRUITING
Johnstown
Sechler Family Cancer Center
RECRUITING
Lebanon
UPMC Cancer Center at UPMC McKeesport
RECRUITING
Mckeesport
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
RECRUITING
Mechanicsburg
UPMC Hillman Cancer Center - Monroeville
RECRUITING
Monroeville
UPMC Hillman Cancer Center in Coraopolis
RECRUITING
Moon Township
UPMC Hillman Cancer Center - Part of Frick Hospital
RECRUITING
Mount Pleasant
Arnold Palmer Cancer Center Medical Oncology Norwin
RECRUITING
N. Huntingdon
UPMC Cancer Center-Natrona Heights
RECRUITING
Natrona Heights
UPMC Hillman Cancer Center - New Castle
RECRUITING
New Castle
University of Pittsburgh Cancer Institute (UPCI)
RECRUITING
Pittsburgh
UPMC-Passavant Hospital
RECRUITING
Pittsburgh
UPMC-Saint Clair Hospital Cancer Center
RECRUITING
Pittsburgh
UPMC-Saint Margaret
RECRUITING
Pittsburgh
UPMC Cancer Center at UPMC Northwest
RECRUITING
Seneca
UPMC Cancer Center-Washington
RECRUITING
Washington
Divine Providence Hospital
RECRUITING
Williamsport
UPMC Susquehanna
RECRUITING
Williamsport
Cancer Care Associates of York
RECRUITING
York
South Carolina
Saint Joseph's/Candler - Bluffton Campus
RECRUITING
Bluffton
South Carolina Cancer Specialists PC
RECRUITING
Hilton Head Island
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
University of Virginia Cancer Center
RECRUITING
Charlottesville
Kaiser Permanente Tysons Corner Medical Center
RECRUITING
Mclean
Kaiser Permanente-Caton Hill Medical Center
RECRUITING
Woodbridge
Vermont
Dartmouth Cancer Center - North
RECRUITING
Saint Johnsbury
White River Junction Veteran Administration Medical Center
RECRUITING
White River Junction
Wisconsin
Duluth Clinic Ashland
RECRUITING
Ashland
Saint Vincent Hospital Cancer Center at Saint Mary's
RECRUITING
Green Bay
Saint Vincent Hospital Cancer Center Green Bay
RECRUITING
Green Bay
Gundersen Lutheran Medical Center
RECRUITING
La Crosse
Saint Vincent Hospital Cancer Center at Oconto Falls
RECRUITING
Oconto Falls
Saint Vincent Hospital Cancer Center at Sheboygan
RECRUITING
Sheboygan
Sheboygan Physicians Group
RECRUITING
Sheboygan
Saint Vincent Hospital Cancer Center at Sturgeon Bay
RECRUITING
Sturgeon Bay
West Virginia
United Hospital Center
SUSPENDED
Bridgeport
Edwards Comprehensive Cancer Center
RECRUITING
Huntington
West Virginia University Healthcare
RECRUITING
Morgantown
Camden Clark Medical Center
SUSPENDED
Parkersburg
Wheeling Hospital/Schiffler Cancer Center
SUSPENDED
Wheeling
Contact Information
Primary
Jennifer Beeler
jbeeler@swog.org
210-614-8808
Backup
SWOG Network Operations Center
protocols@swog.org
Time Frame
Start Date: 2025-05-22
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 378
Treatments
Active_comparator: Arm I (ramucirumab, docetaxel)
Patients receive dexamethasone PO BID on days 0-2, ramucirumab IV over 30-60 minutes on day 1 and docetaxel IV over 60 minutes on day 1 of each cycle (each cycle is 21 days). Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, and CT or MRI throughout the study.
Experimental: Arm II (cemiplimab, ramucirumab, docetaxel)
Patients receive dexamethasone PO BID on days 0-2, ramucirumab IV over 30-60 minutes on day 1, docetaxel IV over 60 minutes on day 1, and cemiplimab IV over 30 minutes on day 1 of each cycle (each cycle is 21 days). Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, and CT or MRI throughout the study.
Sponsors
Collaborators: Regeneron Pharmaceuticals, National Cancer Institute (NCI)
Leads: SWOG Cancer Research Network

This content was sourced from clinicaltrials.gov