Adding the Immunotherapy Drug Cemiplimab to Usual Treatment for People With Advanced Non-Small Cell Lung Cancer Who Had Previous Treatment With Platinum Chemotherapy and Immunotherapy (An Expanded Lung-MAP Treatment Trial)
Purpose
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.
Conditions
- Recurrent Lung Non-Small Cell Carcinoma
- Stage IV Lung Cancer AJCC v8
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Criteria
Inclusion Criteria:
- 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
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Daphne, Alabama 36526
Fairhope, Alabama 36532
Site Public Contact
251-435-4584
Mobile, Alabama 36607
Site Public Contact
251-435-3942
Saraland, Alabama 36571
Anchorage, Alaska 99508
Tucson, Arizona 85719
Tucson, Arizona 85719
Jonesboro, Arkansas 72401
Anaheim, California 92806
Baldwin Park, California 91706
Bellflower, California 90706
Beverly Hills, California 90211
Chico, California 95926
Site Public Contact
530-332-4700
Duarte, California 91010
Fontana, California 92335
Fresno, California 93720
Site Public Contact
833-574-2273
Fresno, California 93720
Harbor City, California 90710
Irvine, California 92618
Site Public Contact
877-467-3411
Irvine, California 92618
La Jolla, California 92093
Lancaster, California 93534
Loma Linda, California 92354
Site Public Contact
909-558-4050
Los Angeles, California 90027
Los Angeles, California 90034
Los Angeles, California 90048
Marysville, California 95901
Site Public Contact
530-749-4400
Mather, California 95655
Oakland, California 94611
Ontario, California 91761
Panorama City, California 91402
Rancho Mirage, California 92270
Site Public Contact
760-834-3798
Riverside, California 92505
Roseville, California 95661
Sacramento, California 95814
Sacramento, California 95817
Site Public Contact
916-734-3089
San Diego, California 92120
San Francisco, California 94115
San Francisco, California 94121
Site Public Contact
415-221-4810
San Jose, California 95119
San Leandro, California 94577
San Marcos, California 92078
San Mateo, California 94401
San Rafael, California 94903
Santa Clara, California 95051
South San Francisco, California 94080
Tarzana, California 91356
Site Public Contact
818-981-3818
Torrance, California 90503
Site Public Contact
877-467-3411
Torrance, California 90505
Truckee, California 96161
Site Public Contact
530-582-6450
Upland, California 91786
Vallejo, California 94589
Walnut Creek, California 94596
Woodland Hills, California 91367
Derby, Connecticut 06418
Fairfield, Connecticut 06824
Greenwich, Connecticut 06830
Guilford, Connecticut 06437
New Haven, Connecticut 06520
North Haven, Connecticut 06473
Stamford, Connecticut 06902
Torrington, Connecticut 06790
Trumbull, Connecticut 06611
Waterbury, Connecticut 06708
Waterford, Connecticut 06385
Millville, Delaware 19967
Newark, Delaware 19713
Newark, Delaware 19713
Rehoboth Beach, Delaware 19971
Washington D.C., District of Columbia 20002
Gainesville, Florida 32610
Tampa, Florida 33612
Atlanta, Georgia 30303
Site Public Contact
404-778-1868
Atlanta, Georgia 30308
Site Public Contact
888-946-7447
Atlanta, Georgia 30322
Site Public Contact
404-778-1868
Atlanta, Georgia 30342
Site Public Contact
404-851-7115
Atlanta, Georgia 30342
Decatur, Georgia 30033
Site Public Contact
404-321-6111
Duluth, Georgia 30096
Gainesville, Georgia 30501
Johns Creek, Georgia 30097
Lawrenceville, Georgia 30046
Savannah, Georgia 31405
Boise, Idaho 83706
Boise, Idaho 83712
Caldwell, Idaho 83605
Coeur d'Alene, Idaho 83814
Fruitland, Idaho 83619
Meridian, Idaho 83642
Meridian, Idaho 83642
Nampa, Idaho 83687
Nampa, Idaho 83687
Post Falls, Idaho 83854
Sandpoint, Idaho 83864
Aurora, Illinois 60506
Barrington, Illinois 60010
Site Public Contact
847-842-4847
Bloomington, Illinois 61704
Canton, Illinois 61520
Carthage, Illinois 62321
Chicago, Illinois 60611
Chicago, Illinois 60657
Site Public Contact
773-296-5360
Crystal Lake, Illinois 60014
Danville, Illinois 61832
Decatur, Illinois 62526
Decatur, Illinois 62526
DeKalb, Illinois 60115
Dixon, Illinois 61021
Site Public Contact
815-285-7800
Downers Grove, Illinois 60515
Effingham, Illinois 62401
Effingham, Illinois 62401
Elgin, Illinois 60123
Site Public Contact
847-429-2907
Eureka, Illinois 61530
Galesburg, Illinois 61401
Geneva, Illinois 60134
Glenview, Illinois 60026
Site Public Contact
312-695-1102
Grayslake, Illinois 60030
Site Public Contact
312-695-1102
Hazel Crest, Illinois 60429
Site Public Contact
708-799-9995
Kewanee, Illinois 61443
Lake Forest, Illinois 60045
Libertyville, Illinois 60048
Libertyville, Illinois 60048
Macomb, Illinois 61455
Mattoon, Illinois 61938
Maywood, Illinois 60153
Site Public Contact
708-226-4357
Normal, Illinois 61761
Normal, Illinois 61761
O'Fallon, Illinois 62269
O'Fallon, Illinois 62269
Oak Brook, Illinois 60523
Oak Lawn, Illinois 60453-2699
Site Public Contact
800-323-8622
Oak Lawn, Illinois 60453
Orland Park, Illinois 60462
Ottawa, Illinois 61350
Palos Heights, Illinois 60463
Park Ridge, Illinois 60068
Site Public Contact
847-384-3621
Pekin, Illinois 61554
Peoria, Illinois 61615
Peru, Illinois 61354
Princeton, Illinois 61356
Shiloh, Illinois 62269
Springfield, Illinois 62702
Site Public Contact
217-545-7929
Springfield, Illinois 62702
Site Public Contact
800-444-7541
Springfield, Illinois 62781
Urbana, Illinois 61801
Warrenville, Illinois 60555
Washington, Illinois 61571
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
Fairway, Kansas 66205
Hays, Kansas 67601
Site Public Contact
785-623-5774
Kansas City, Kansas 66160
Lawrence, Kansas 66044
Leavenworth, Kansas 66048
Olathe, Kansas 66061
Overland Park, Kansas 66210
Overland Park, Kansas 66211
Salina, Kansas 67401
Topeka, Kansas 66606
Site Public Contact
785-295-8000
Westwood, Kansas 66205
Lexington, Kentucky 40536
Site Public Contact
859-257-3379
Augusta, Maine 04330
Site Public Contact
207-626-4855
Belfast, Maine 04915
Brewer, Maine 04412
Site Public Contact
800-987-3005
Brunswick, Maine 04011
Damariscotta, Maine 04543
Rockport, Maine 04856
Sanford, Maine 04073
Site Public Contact
207-459-1600
South Portland, Maine 04106
Baltimore, Maryland 21229
Site Public Contact
410-368-2910
Baltimore, Maryland 21244
Cumberland, Maryland 21502
Site Public Contact
240-964-1400
Gaithersburg, Maryland 20879
Largo, Maryland 20774
Lutherville, Maryland 21093
Beverly, Massachusetts 01915
Site Public Contact
978-922-3000
Burlington, Massachusetts 01805
Gloucester, Massachusetts 01930
Site Public Contact
978-283-4000
Peabody, Massachusetts 01960
Springfield, Massachusetts 01199
Worcester, Massachusetts 01655
Brighton, Michigan 48114
Canton, Michigan 48188
Chelsea, Michigan 48118
Escanaba, Michigan 49829
Flint, Michigan 48503
Flint, Michigan 48503
Lansing, Michigan 48912
Livonia, Michigan 48154
Pontiac, Michigan 48341
Ypsilanti, Michigan 48197
Bemidji, Minnesota 56601
Brainerd, Minnesota 56401
Coon Rapids, Minnesota 55433
Deer River, Minnesota 56636
Duluth, Minnesota 55805
Edina, Minnesota 55435
Hibbing, Minnesota 55746
Site Public Contact
218-786-3308
Minneapolis, Minnesota 55407
Robbinsdale, Minnesota 55422
Saint Louis Park, Minnesota 55416
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55102
Sandstone, Minnesota 55072
Virginia, Minnesota 55792
Woodbury, Minnesota 55125
Worthington, Minnesota 56187
Site Public Contact
605-312-3320
Columbus, Mississippi 39705
Grenada, Mississippi 38901
Gulfport, Mississippi 39502
New Albany, Mississippi 38652
Oxford, Mississippi 38655
Southhaven, Mississippi 38671
Cape Girardeau, Missouri 63703
City of Saint Peters, Missouri 63376
Creve Coeur, Missouri 63141
Farmington, Missouri 63640
Site Public Contact
314-996-5569
Kansas City, Missouri 64108
Site Public Contact
816-404-4375
Kansas City, Missouri 64116
Site Public Contact
913-588-3671
Kansas City, Missouri 64128
Site Public Contact
800-525-1483
Kansas City, Missouri 64154
Lee's Summit, Missouri 64064
Osage Beach, Missouri 65065
Sainte Genevieve, Missouri 63670
Site Public Contact
314-996-5569
St Louis, Missouri 63110
St Louis, Missouri 63128
St Louis, Missouri 63129
St Louis, Missouri 63131
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314-996-5569
St Louis, Missouri 63136
Sullivan, Missouri 63080
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314-996-5569
Sunset Hills, Missouri 63127
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314-996-5569
Anaconda, Montana 59711
Billings, Montana 59101
Bozeman, Montana 59715
Great Falls, Montana 59405
Kalispell, Montana 59901
Missoula, Montana 59804
Concord, New Hampshire 03301
Site Public Contact
603-224-2556
Lebanon, New Hampshire 03756
Manchester, New Hampshire 03103
Site Public Contact
800-339-6484
Moorestown, New Jersey 08057
Voorhees Township, New Jersey 08043
Albuquerque, New Mexico 87106
Rochester, New York 14642
Site Public Contact
585-275-5830
The Bronx, New York 10461
The Bronx, New York 10468
Webster, New York 14580
Durham, North Carolina 27705
Pinehurst, North Carolina 28374
Bismarck, North Dakota 58501
Fargo, North Dakota 58103
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Athens, Ohio 45701
Canton, Ohio 44710
Centerville, Ohio 45459
Columbus, Ohio 43214
Columbus, Ohio 43214
Columbus, Ohio 43215
Columbus, Ohio 43228
Dayton, Ohio 45409
Dayton, Ohio 45409
Site Public Contact
937-276-8320
Dayton, Ohio 45415
Delaware, Ohio 43015
Delaware, Ohio 43015
Dublin, Ohio 43016
Dublin, Ohio 43016
Franklin, Ohio 45005-1066
Greenville, Ohio 45331
Site Public Contact
937-569-7515
Mansfield, Ohio 44903
Marion, Ohio 43302
Pickerington, Ohio 43147
Sylvania, Ohio 43560
Troy, Ohio 45373
Westerville, Ohio 43082
Lawton, Oklahoma 73505
Site Public Contact
877-231-4440
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73109
Oklahoma City, Oklahoma 73120
Site Public Contact
405-752-3402
Baker City, Oregon 97814
Newberg, Oregon 97132
Ontario, Oregon 97914
Oregon City, Oregon 97045
Portland, Oregon 97213
Portland, Oregon 97225
Portland, Oregon 97239
Salem, Oregon 97301
Site Public Contact
503-561-2618
Beaver, Pennsylvania 15009
Butler, Pennsylvania 16001
Chambersburg, Pennsylvania 17201
Site Public Contact
717-217-6020
Cranberry Township, Pennsylvania 16066
Ephrata, Pennsylvania 17522
Site Public Contact
717-721-4840
Erie, Pennsylvania 16505
Farrell, Pennsylvania 16121
Gettysburg, Pennsylvania 17325
Site Public Contact
877-441-7957
Greensburg, Pennsylvania 15601
Site Public Contact
724-838-1900
Harrisburg, Pennsylvania 17109
Indiana, Pennsylvania 15701
Johnstown, Pennsylvania 15901
Site Public Contact
814-534-4724
Lebanon, Pennsylvania 17042
McKeesport, Pennsylvania 15132
Site Public Contact
412-647-8073
Mechanicsburg, Pennsylvania 17050
Monroeville, Pennsylvania 15146
Moon Township, Pennsylvania 15108
Mount Pleasant, Pennsylvania 15666
N. Huntingdon, Pennsylvania 15642
Natrona Heights, Pennsylvania 15065
Site Public Contact
724-230-3030
New Castle, Pennsylvania 16105
Philadelphia, Pennsylvania 19111
Site Public Contact
215-728-4790
Philadelphia, Pennsylvania 19140
Site Public Contact
215-728-2983
Pittsburgh, Pennsylvania 15215
Site Public Contact
412-784-4900
Pittsburgh, Pennsylvania 15232
Site Public Contact
412-647-8073
Pittsburgh, Pennsylvania 15237
Site Public Contact
412-367-6454
Pittsburgh, Pennsylvania 15243
Site Public Contact
412-502-3920
Seneca, Pennsylvania 16346
Site Public Contact
814-676-7900
Uniontown, Pennsylvania 15401
Washington, Pennsylvania 15301
Williamsport, Pennsylvania 17701
Site Public Contact
800-598-4282
Williamsport, Pennsylvania 17754
York, Pennsylvania 17403
Site Public Contact
717-741-9229
Anderson, South Carolina 29621
Bluffton, South Carolina 29910
Charleston, South Carolina 29425
Gaffney, South Carolina 29341
Greer, South Carolina 29651
Hilton Head Island, South Carolina 29926-3827
Spartanburg, South Carolina 29303
Union, South Carolina 29379
Rapid City, South Dakota 57701
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57117-5134
Collierville, Tennessee 38017
Memphis, Tennessee 38120
Amarillo, Texas 79106
Salt Lake City, Utah 84112
Saint Johnsbury, Vermont 05819
White River Junction, Vermont 05009
Site Public Contact
866-687-8387
Charlottesville, Virginia 22908
Lynchburg, Virginia 24501
McLean, Virginia 22102
Richmond, Virginia 23229
Richmond, Virginia 23235
Richmond, Virginia 23298
South Hill, Virginia 23970
Woodbridge, Virginia 22192
Bridgeport, West Virginia 26330
Huntington, West Virginia 25701
Martinsburg, West Virginia 25401
Morgantown, West Virginia 26506
Parkersburg, West Virginia 26101
Wheeling, West Virginia 26003
Site Public Contact
304-243-6442
Ashland, Wisconsin 54806
Burlington, Wisconsin 53105
Cudahy, Wisconsin 53110
Germantown, Wisconsin 53022
Grafton, Wisconsin 53024
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54303
Green Bay, Wisconsin 54311
Kenosha, Wisconsin 53142
La Crosse, Wisconsin 54601
Madison, Wisconsin 53718
Madison, Wisconsin 53792
Marinette, Wisconsin 54143
Milwaukee, Wisconsin 53209
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53233
Oconto Falls, Wisconsin 54154
Oshkosh, Wisconsin 54904
Racine, Wisconsin 53406
Sheboygan, Wisconsin 53081
Sheboygan, Wisconsin 53081
Sheboygan, Wisconsin 53081
Stevens Point, Wisconsin 54482
Sturgeon Bay, Wisconsin 54235-1495
Summit, Wisconsin 53066
Two Rivers, Wisconsin 54241
Wauwatosa, Wisconsin 53226
West Allis, Wisconsin 53227
Weston, Wisconsin 54476
More Details
- NCT ID
- NCT06616584
- Status
- Recruiting
- Sponsor
- SWOG Cancer Research Network
Detailed Description
PRIMARY OBJECTIVE: I. To compare overall survival (OS) between participants randomized to docetaxel and ramucirumab with or without cemiplimab (REGN2810) who have acquired resistance to platinum-based chemotherapy and immunotherapy for stage IV or recurrent non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVES: I. To compare investigator-assessed progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 between the arms. II. To compare investigator-assessed response rates (confirmed or unconfirmed, complete response [CR] or partial response [PR]) per RECIST 1.1 between the arms among participants with measurable disease. III. To compare the investigator-assessed disease control rate (confirmed or unconfirmed, complete response [CR], or partial response [PR], and stable disease) between the arms. IV. To evaluate the duration of response (DoR) among responders within each arm. V. To evaluate the frequency and severity of toxicities within each arm. VI. To compare investigator-assessed PFS between the arms within the subgroups defined by the stratification factors (histology and performance status) and by PD-L1 subgroups defined as PD-L1 negative (< 1% tumor proportion score [TPS]), intermediate PD-L1 (1-49% TPS), and PD-L1 high (>= 50% TPS). VII. To compare OS between the arms within the subgroups defined by the stratification factors (histology and performance status) and by PD-L1 subgroups defined as PD-L1 negative (< 1% TPS), intermediate PD-L1 (1-49% TPS), and PD-L1 high (>= 50% TPS). TRANSLATIONAL MEDICINE OBJECTIVES: I. To collect, process, and bank cell-free deoxyribonucleic acid (cfDNA) at baseline, cycle 3 day 1, and progression for future development of a proposal to evaluate comprehensive next-generation sequencing of circulating tumor DNA (ctDNA). II. To establish a tissue/blood repository to pursue future studies. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive dexamethasone orally (PO) twice daily (BID) on days 0-2, ramucirumab intravenously (IV) over 30-60 minutes on day 1 and docetaxel IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, and computed tomography (CT) or magnetic resonance imaging (MRI) throughout the study. ARM II: 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. 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. After completion of study treatment, patients are followed up every 3-6 months for up to 3 years after randomization.