Testing the Use of Combination Immunotherapy Treatment (N-803 [ALT-803] Plus Pembrolizumab) Against the Usual Treatment for Advanced Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial)
Advanced Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8
About this trial
This is an interventional treatment trial for Advanced Lung Non-Small Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Participants must have been assigned to S1800D by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1800D is determined by the LUNGMAP or S1400 protocol
- Participants must have measurable or non-measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI). Measurable disease must be assessed within 28 days prior to randomization. Non-measurable disease must be assessed within 42 days prior to randomization. The CT from a combined positron emission tomography (PET)/CT may be used only if it is of diagnostic quality. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1)
- 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 with spinal cord compression or brain metastases must have received local treatment to these metastases and remained clinically controlled and asymptomatic for at least 7 days following stereotactic radiation and/or 14 days following whole brain radiation, and prior to sub-study randomization
- Participants with spinal cord compression or brain metastases must not have residual neurological dysfunction, unless no further recovery is expected, and the participant has been stable on weaning doses of corticosteroids (=< 10 mg daily prednisone or equivalent) prior to sub-study randomization
- Participants must have progressed (in the opinion of the treating investigator) following the most recent line of therapy for non-small cell lung cancer (NSCLC)
- Participants with a known sensitizing mutation for which an FDA-approved targeted therapy for NSCLC exists (e.g. EGFR, ALK gene fusions, ROS1, BRAF, RET, NTRK, and MET sensitizing mutations), must have previously received at least one of the approved therapy(s)
Participants must have received exactly one line of anti-PD-1 or anti-PD-L1 therapy for advanced disease (stage IV or recurrent, or stage III in certain circumstances outlined below) given alone or in combination with platinum-based chemotherapy. Participants must have experienced disease progression during or after this regimen
- Continuing the same agent(s) after progression counts as a single line of therapy. However, a change or addition in agent(s) after progression (e.g. the addition of chemotherapy to anti-PD-1 monotherapy after progression) counts as a subsequent line of therapy and would exclude the participant
For participants who received consolidation anti-PD-1 or anti-PD-L1 therapy following concurrent chemoradiation for Stage III disease as their only line of anti-PD-1 or anti-PD-L1 therapy:
- If they experienced disease progression less than (<) 365 days from the first date of anti-PD-1 or anti-PD-L1 therapy, this counts as the single line of anti-PD-1 or anti-PD-L1 therapy for advanced disease
- If they experienced disease progression more than or equal to (>=) 365 days from the first date of anti-PD-1 or anti-PD-L1 therapy, this is not considered a line of anti-PD-1 or anti-PD-L1 therapy for advanced disease
- Participants must have recovered (=< grade 1) from any side effects of prior therapy, except for alopecia
Participants must be able to safely receive at least one of the investigator's choice of standard of care regimens, per the current FDA-approved package insert
- Note: Pemetrexed is not FDA-approved for squamous cell NSCLC and must not be used to treat participants with squamous cell NSCLC
- Absolute neutrophil count (ANC) >= 1.5 x 10^3/uL (obtained within 28 days prior to sub-study randomization)
- Platelet count >= 100 x 10^3/uL(obtained within 28 days prior to sub-study randomization)
- Hemoglobin >= 9 g/dL (obtained within 28 days prior to sub-study randomization)
- Serum bilirubin =< institutional upper limit of normal (IULN) (within 28 days prior to sub-study randomization). For participants with liver metastases, bilirubin must be =< 5 x IULN
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2 x IULN (within 28 days prior to sub-study randomization). For participants with liver metastases, ALT and AST must be =< 5 x IULN
- Serum creatinine =< the IULN or calculated creatinine clearance >= 50 mL/min using Cockcroft-Gault formula. This specimen must have been drawn and processed 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 history and physical exam must be obtained within 28 days prior to sub-study randomization
- Participants with known human immunodeficiency virus (HIV) infection must be receiving anti-retroviral therapy and have an undetectable viral load at their most recent viral load test within 6 months prior to sub-study randomization
- Participants must also be offered participation in banking and in the correlative studies for collection and future use of specimens
Note: As a part of the 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 written informed consent in accordance with institutional and federal guidelines
Exclusion Criteria:
- Participants must not have leptomeningeal disease that requires CNS-specific treatment prior to registration and must not be planning to receive the CNS-specific treatment through the first cycle of the protocol therapy
Participants must not have experienced the following:
- Any grade 3 or worse immune-related adverse event (irAE). Exception: asymptomatic nonbullous/nonexfoliative rash
- Any unresolved grade 2 irAE
- 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 history of (non-infectious) pneumonitis that required steroids or current pneumonitis/interstitial lung disease
- Participants must not have any known allergy or reaction to any component of the investigational formulations. If there is a known allergy or reaction to standard of care formulations, participants must be able to safely receive at least one of the standard of care options
- 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 sub-study 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 sub-study randomization
- Participants must not have an active or uncontrolled infection in the opinion of the treating investigator
- 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 any of following:
- Cirrhosis at a level of Child-Pugh B (or worse)
- Cirrhosis (any degree) and a history of hepatic encephalopathy
- Or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis
- Participants must not have received anti-CTLA4 therapy (e.g. ipilimumab, tremelimumab), or other immune-modulatory therapy (e.g. anti-TIM-3, anti-LAG-3, anti-GITR, IL-2, IL-15)
- 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 any radiation therapy within 14 days prior to sub-study randomization
- Participants must not have received nitrosoureas or mitomycin-c within 42 days prior to sub-study randomization
- Participants must not have received systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 7 days prior to sub-study randomization. Inhaled or topical steroids, and adrenal replacement doses =< 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease
- Participants must not have received a live attenuated vaccination within 28 days prior to sub-study randomization. All COVID-19 vaccines that have received Food and Drug Administration (FDA) approval or FDA emergency use authorization are acceptable
- 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. Participant must have fully recovered from the effects of prior surgery in the opinion of the treating investigator
- Participants must not have an active autoimmune disease that has required systemic treatment within two years prior to sub-study 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 not be pregnant or nursing. Women/men of reproductive potential must have agreed to use an effective contraceptive method during the study and 4 months after completion of study treatment. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures during the study and 4 months after study completion
Sites / Locations
- Veterans Administration Medical Center - Birmingham
- CTCA at Western Regional Medical Center
- University of Arkansas for Medical Sciences
- Kaiser Permanente-Anaheim
- PCR Oncology
- Sutter Auburn Faith Hospital
- Kaiser Permanente-Baldwin Park
- Kaiser Permanente-Bellflower
- Alta Bates Summit Medical Center-Herrick Campus
- Tower Cancer Research Foundation
- Kaiser Permanente-Fontana
- Palo Alto Medical Foundation-Fremont
- Kaiser Permanente - Harbor City
- Kaiser Permanente-Irvine
- Kaiser Permanente Los Angeles Medical Center
- Kaiser Permanente West Los Angeles
- Cedars Sinai Medical Center
- Memorial Medical Center
- Kaiser Permanente-Oakland
- Kaiser Permanente-Ontario
- Palo Alto Medical Foundation Health Care
- Kaiser Permanente - Panorama City
- Eisenhower Medical Center
- Kaiser Permanente-Riverside
- Kaiser Permanente-Roseville
- Sutter Roseville Medical Center
- Kaiser Permanente Downtown Commons
- Sutter Medical Center Sacramento
- University of California Davis Comprehensive Cancer Center
- Kaiser Permanente-San Diego Zion
- California Pacific Medical Center-Pacific Campus
- Kaiser Permanente-San Francisco
- Veterans Affairs Medical Center - San Francisco
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente San Leandro
- Kaiser Permanente-San Marcos
- Kaiser Permanente Medical Center - Santa Clara
- Palo Alto Medical Foundation-Santa Cruz
- Kaiser Permanente-South San Francisco
- Palo Alto Medical Foundation-Sunnyvale
- Torrance Memorial Physician Network - Cancer Care
- Kaiser Permanente-Vallejo
- Sutter Solano Medical Center/Cancer Center
- Kaiser Permanente-Walnut Creek
- Presbyterian Intercommunity Hospital
- Kaiser Permanente-Woodland Hills
- Veterans Affairs Connecticut Healthcare System-West Haven Campus
- Bayhealth Hospital Kent Campus
- Beebe South Coastal Health Campus
- Bayhealth Hospital Sussex Campus
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Beebe Health Campus
- Kaiser Permanente-Capitol Hill Medical Center
- Mount Sinai Medical Center
- Northside Hospital
- Northside Hospital - Duluth
- Northeast Georgia Medical Center-Gainesville
- Northside Hospital - Gwinnett
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Saint Alphonsus Cancer Care Center-Boise
- Saint Luke's Cancer Institute - Boise
- Saint Luke's Cancer Institute - Fruitland
- Saint Luke's Cancer Institute - Meridian
- Saint Luke's Cancer Institute - Nampa
- Saint Luke's Cancer Institute - Twin Falls
- Illinois CancerCare-Bloomington
- Illinois CancerCare-Canton
- Illinois CancerCare-Carthage
- Centralia Oncology Clinic
- Northwestern University
- Carle on Vermilion
- Cancer Care Specialists of Illinois - Decatur
- Illinois CancerCare-Dixon
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Illinois CancerCare-Eureka
- Illinois CancerCare-Galesburg
- Edward Hines Jr VA Hospital
- Illinois CancerCare-Kewanee Clinic
- Northwestern Medicine Lake Forest Hospital
- Illinois CancerCare-Macomb
- Carle Physician Group-Mattoon/Charleston
- Cancer Care Center of O'Fallon
- Illinois CancerCare-Ottawa Clinic
- Illinois CancerCare-Pekin
- Illinois CancerCare-Peoria
- Illinois CancerCare-Peru
- Illinois CancerCare-Princeton
- Mercyhealth Javon Bea Hospital - Rockton
- Southern Illinois University School of Medicine
- Springfield Clinic
- Memorial Medical Center
- Carle Cancer Center
- The Carle Foundation Hospital
- Illinois CancerCare - Washington
- Indiana University/Melvin and Bren Simon Cancer Center
- Memorial Hospital of South Bend
- Mary Greeley Medical Center
- McFarland Clinic PC - Ames
- University of Iowa Healthcare Cancer Services Quad Cities
- McFarland Clinic PC-Boone
- Mercy Hospital
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Greater Regional Medical Center
- Mission Cancer and Blood - Laurel
- McFarland Clinic PC-Trinity Cancer Center
- McFarland Clinic PC-Jefferson
- McFarland Clinic PC-Marshalltown
- Mercy Medical Center-West Lakes
- HaysMed University of Kansas Health System
- Lawrence Memorial Hospital
- Olathe Health Cancer Center
- University of Kansas Cancer Center-Overland Park
- University of Kansas Hospital-Indian Creek Campus
- Salina Regional Health Center
- University of Kansas Health System Saint Francis Campus
- University of Kansas Hospital-Westwood Cancer Center
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Ascension Via Christi Hospitals Wichita
- Cancer Center of Kansas - Wichita
- University of Kentucky/Markey Cancer Center
- Owensboro Health Mitchell Memorial Cancer Center
- Louisiana Hematology Oncology Associates LLC
- Harold Alfond Center for Cancer Care
- MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
- Lafayette Family Cancer Center-EMMC
- MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
- Kaiser Permanente-Woodlawn Medical Center
- UPMC Western Maryland
- Kaiser Permanente-Gaithersburg Medical Center
- Kaiser Permanente - Kensington Medical Center
- Kaiser Permanente - Largo Medical Center
- William E Kahlert Regional Cancer Center/Sinai Hospital
- Beverly Hospital
- Lahey Hospital and Medical Center
- Addison Gilbert Hospital
- Lahey Medical Center-Peabody
- UMass Memorial Medical Center - University Campus
- Saint Joseph Mercy Hospital
- University of Michigan Comprehensive Cancer Center
- Bronson Battle Creek
- Saint Joseph Mercy Brighton
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
- Saint Joseph Mercy Canton
- Trinity Health IHA Medical Group Hematology Oncology - Canton
- Saint Joseph Mercy Chelsea
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
- Ascension Saint John Hospital
- Great Lakes Cancer Management Specialists-Doctors Park
- Genesee Cancer and Blood Disease Treatment Center
- Genesee Hematology Oncology PC
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Academic Hematology Oncology Specialists
- Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Ascension Borgess Cancer Center
- Sparrow Hospital
- Trinity Health Saint Mary Mercy Livonia Hospital
- Great Lakes Cancer Management Specialists-Macomb Medical Campus
- Ascension Providence Hospitals - Novi
- Ascension Saint Mary's Hospital
- Oncology Hematology Associates of Saginaw Valley PC
- Marie Yeager Cancer Center
- Ascension Providence Hospitals - Southfield
- Bhadresh Nayak MD PC-Sterling Heights
- Ascension Saint Joseph Hospital
- Great Lakes Cancer Management Specialists-Macomb Professional Building
- Saint John Macomb-Oakland Hospital
- Huron Gastroenterology PC
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
- Sanford Joe Lueken Cancer Center
- Essentia Health - Deer River Clinic
- Essentia Health Cancer Center
- Unity Hospital
- Essentia Health Hibbing Clinic
- Abbott-Northwestern Hospital
- Minneapolis VA Medical Center
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- Essentia Health Sandstone
- Essentia Health Virginia Clinic
- University of Mississippi Medical Center
- Saint Francis Medical Center
- Siteman Cancer Center at West County Hospital
- Parkland Health Center - Farmington
- Truman Medical Centers
- University of Kansas Cancer Center - North
- University of Kansas Cancer Center - Lee's Summit
- University of Kansas Cancer Center at North Kansas City Hospital
- Washington University School of Medicine
- Siteman Cancer Center-South County
- Missouri Baptist Medical Center
- Siteman Cancer Center at Christian Hospital
- Siteman Cancer Center at Saint Peters Hospital
- Sainte Genevieve County Memorial Hospital
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- Bozeman Deaconess Hospital
- OptumCare Cancer Care at Charleston
- OptumCare Cancer Care at Fort Apache
- Renown Regional Medical Center
- New Hampshire Oncology Hematology PA-Concord
- Dartmouth Hitchcock Medical Center
- Solinsky Center for Cancer Care
- Virtua Samson Cancer Center
- Virtua Voorhees
- University of New Mexico Cancer Center
- Presbyterian Kaseman Hospital
- Memorial Medical Center - Las Cruces
- Presbyterian Rust Medical Center/Jorgensen Cancer Center
- Mary Imogene Bassett Hospital
- Cancer Institute at Saint Francis Hospital
- Arnot Ogden Medical Center/Falck Cancer Center
- University of Rochester
- Good Samaritan Hospital Medical Center
- Randolph Hospital
- AdventHealth Infusion Center Asheville
- Cone Health Cancer Center at Alamance Regional
- AdventHealth Infusion Center Haywood
- Durham VA Medical Center
- Duke University Medical Center
- Cone Health Cancer Center
- AdventHealth Hendersonville
- Cone Heath Cancer Center at Mebane
- FirstHealth of the Carolinas-Moore Regional Hospital
- Duke Women's Cancer Care Raleigh
- Duke Raleigh Hospital
- Annie Penn Memorial Hospital
- AdventHealth Infusion Center Weaverville
- Sanford Bismarck Medical Center
- Sanford Broadway Medical Center
- Sanford Roger Maris Cancer Center
- Strecker Cancer Center-Belpre
- Cleveland Clinic Mercy Hospital
- Adena Regional Medical Center
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Grant Medical Center
- The Mark H Zangmeister Center
- Doctors Hospital
- Delaware Health Center-Grady Cancer Center
- Cleveland Clinic Cancer Center Mansfield
- OhioHealth Marion General Hospital
- Hillcrest Hospital Cancer Center
- Knox Community Hospital
- Licking Memorial Hospital
- Southern Ohio Medical Center
- North Coast Cancer Care
- Springfield Regional Cancer Center
- Springfield Regional Medical Center
- Trinity's Tony Teramana Cancer Center
- Cleveland Clinic Cancer Center Strongsville
- ProMedica Flower Hospital
- South Pointe Hospital
- Saint Ann's Hospital
- Cleveland Clinic Wooster Family Health and Surgery Center
- Genesis Healthcare System Cancer Care Center
- Cancer Centers of Southwest Oklahoma Research
- University of Oklahoma Health Sciences Center
- Mercy Hospital Oklahoma City
- Kaiser Permanente Northwest
- Oregon Health and Science University
- UPMC Altoona
- UPMC-Heritage Valley Health System Beaver
- UPMC Hillman Cancer Center at Butler Health System
- UPMC Camp Hill
- Carlisle Regional Cancer Center
- WellSpan Medical Oncology and Hematology
- UPMC Hillman Cancer Center - Passavant - Cranberry
- Ephrata Cancer Center
- UPMC Hillman Cancer Center Erie
- UPMC Cancer Center at UPMC Horizon
- Adams Cancer Center
- UPMC Cancer Centers - Arnold Palmer Pavilion
- Oncology Hematology Associates
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
- IRMC Cancer Center
- UPMC-Johnstown/John P. Murtha Regional Cancer Center
- Sechler Family Cancer Center
- UPMC Cancer Center at UPMC McKeesport
- UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
- UPMC Hillman Cancer Center - Monroeville
- UPMC-Coraopolis/Heritage Valley Radiation Oncology
- UPMC Hillman Cancer Center - Part of Frick Hospital
- Arnold Palmer Cancer Center Medical Oncology Norwin
- UPMC Cancer Center-Natrona Heights
- UPMC Hillman Cancer Center - New Castle
- Fox Chase Cancer Center
- Temple University Hospital
- UPMC-Mercy Hospital
- University of Pittsburgh Cancer Institute (UPCI)
- UPMC-Passavant Hospital
- UPMC-Saint Clair Hospital Cancer Center
- Pottstown Hospital
- UPMC Cancer Center at UPMC Northwest
- UPMC Cancer Center-Uniontown
- UPMC Cancer Center-Washington
- UPMC West Mifflin-Cancer Center Jefferson
- Divine Providence Hospital
- Cancer Care Associates of York
- WellSpan Health-York Cancer Center
- WellSpan Health-York Hospital
- UPMC Memorial
- AnMed Health Cancer Center
- Prisma Health Cancer Institute - Spartanburg
- Ralph H Johnson VA Medical Center
- Medical University of South Carolina
- Prisma Health Cancer Institute - Easley
- Prisma Health Cancer Institute - Butternut
- Prisma Health Cancer Institute - Faris
- Prisma Health Greenville Memorial Hospital
- Prisma Health Cancer Institute - Eastside
- Prisma Health Cancer Institute - Greer
- Prisma Health Cancer Institute - Seneca
- Sanford Cancer Center Oncology Clinic
- Sanford USD Medical Center - Sioux Falls
- The Don and Sybil Harrington Cancer Center
- Parkland Memorial Hospital
- UT Southwestern/Simmons Cancer Center-Dallas
- UT Southwestern/Simmons Cancer Center-Fort Worth
- UT Southwestern Clinical Center at Richardson/Plano
- Kaiser Permanente-Burke Medical Center
- Kaiser Permanente Tysons Corner Medical Center
- West Virginia University Charleston Division
- Edwards Comprehensive Cancer Center
- West Virginia University Healthcare
- Duluth Clinic Ashland
- Aurora Cancer Care-Grafton
- Saint Vincent Hospital Cancer Center Green Bay
- Saint Vincent Hospital Cancer Center at Saint Mary's
- Mercyhealth Hospital and Cancer Center - Janesville
- Gundersen Lutheran Medical Center
- University of Wisconsin Carbone Cancer Center
- Froedtert Menomonee Falls Hospital
- Aurora Saint Luke's Medical Center
- Medical College of Wisconsin
- Aurora Sinai Medical Center
- Saint Vincent Hospital Cancer Center at Oconto Falls
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
- Aurora Medical Center in Summit
- Aurora Cancer Care-Milwaukee West
- Aurora West Allis Medical Center
- Froedtert West Bend Hospital/Kraemer Cancer Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm A (standard of care)
Arm B (pembrolizumab, nogapendekin alfa)
Patients receive standard of care consisting of docetaxel IV over 30-60 minutes on day 1; gemcitabine IV over 30 minutes on days 1 and 8; pemetrexed IV over 10 minutes on day 1; or ramucirumab IV over 30-60 minutes and docetaxel IV over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive pembrolizumab IV over 30 minutes and nogapendekin alfa SC on day 1. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients then receive nogapendekin alfa SC on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.