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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05096663
Other study ID # S1800D
Secondary ID NCI-2021-09852S1
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date March 15, 2022
Est. completion date December 1, 2027

Study information

Verified date May 2024
Source SWOG Cancer Research Network
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II/III Lung-MAP trial studies how well immunotherapy treatment with N-803 (ALT-803) and pembrolizumab working in treating patients with non-small cell lung cancer that has spread to other places in the body (advanced). Natural killer cells, part of our immune system, are always on alert and ready to defend our bodies from many kinds of infection or rogue cells, such as those that cause cancer. N-803 (ALT-803) may activate natural killer cells so that they can stimulate an immune response to help fight cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving N-803 (ALT-803) and pembrolizumab may help shrink and stabilize lung cancer or prevent it from returning.


Description:

PRIMARY OBJECTIVES: I. To compare overall survival (OS) between participants randomized to nogapendekin alfa (N-803 [ALT-803]) + pembrolizumab versus standard of care therapy. (Primary Resistance Cohort) II. To compare overall survival (OS) between participants randomized to N-803 (ALT-803) + pembrolizumab versus standard of care therapy. (Acquired Resistance Cohort) SECONDARY OBJECTIVES: I. To compare investigator assessed progression-free survival (IA-PFS) with confirmation of progression by immune response criteria between the treatment arms. II. To compare investigator assessed progression-free survival (IA-PFS) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 between the treatment arms. III. To compare the response rates between the arms. IV. To evaluate duration of response (DoR) among responders. V. To evaluate the frequency and severity of toxicities within each treatment arm. TRANSLATIONAL MEDICINE OBJECTIVE: I. To establish a blood repository to pursue future studies. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive standard of care consisting of docetaxel intravenously (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. ARM B: Patients receive pembrolizumab IV over 30 minutes and nogapendekin alfa subcutaneously (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. After completion of study treatment, patients are followed up for 2 years.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 82
Est. completion date December 1, 2027
Est. primary completion date February 1, 2027
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Intervention

Dietary Supplement:
Cobalamin
Given intramuscularly
Drug:
Dexamethasone
Given orally (PO)
Docetaxel
Given IV
Dietary Supplement:
Folic Acid
Given PO
Drug:
Gemcitabine
Given IV
Nogapendekin Alfa
Given SC
Biological:
Pembrolizumab
Given IV
Drug:
Pemetrexed
Given IV
Biological:
Ramucirumab
Given IV

Locations

Country Name City State
United States Presbyterian Kaseman Hospital Albuquerque New Mexico
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States UPMC Altoona Altoona Pennsylvania
United States The Don and Sybil Harrington Cancer Center Amarillo Texas
United States Mary Greeley Medical Center Ames Iowa
United States McFarland Clinic PC - Ames Ames Iowa
United States Kaiser Permanente-Anaheim Anaheim California
United States AnMed Health Cancer Center Anderson South Carolina
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States PCR Oncology Arroyo Grande California
United States Randolph Hospital Asheboro North Carolina
United States AdventHealth Infusion Center Asheville Asheville North Carolina
United States Duluth Clinic Ashland Ashland Wisconsin
United States Northside Hospital Atlanta Georgia
United States Sutter Auburn Faith Hospital Auburn California
United States Harold Alfond Center for Cancer Care Augusta Maine
United States Kaiser Permanente-Baldwin Park Baldwin Park California
United States Kaiser Permanente-Woodlawn Medical Center Baltimore Maryland
United States Louisiana Hematology Oncology Associates LLC Baton Rouge Louisiana
United States Bronson Battle Creek Battle Creek Michigan
United States UPMC-Heritage Valley Health System Beaver Beaver Pennsylvania
United States Kaiser Permanente-Bellflower Bellflower California
United States Strecker Cancer Center-Belpre Belpre Ohio
United States Sanford Joe Lueken Cancer Center Bemidji Minnesota
United States Alta Bates Summit Medical Center-Herrick Campus Berkeley California
United States University of Iowa Healthcare Cancer Services Quad Cities Bettendorf Iowa
United States Beverly Hospital Beverly Massachusetts
United States Tower Cancer Research Foundation Beverly Hills California
United States MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford Biddeford Maine
United States Veterans Administration Medical Center - Birmingham Birmingham Alabama
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Saint Luke's Cancer Institute - Boise Boise Idaho
United States McFarland Clinic PC-Boone Boone Iowa
United States Bozeman Deaconess Hospital Bozeman Montana
United States Lafayette Family Cancer Center-EMMC Brewer Maine
United States Saint Joseph Mercy Brighton Brighton Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton Michigan
United States Kaiser Permanente-Burke Medical Center Burke Virginia
United States Cone Health Cancer Center at Alamance Regional Burlington North Carolina
United States Lahey Hospital and Medical Center Burlington Massachusetts
United States UPMC Hillman Cancer Center at Butler Health System Butler Pennsylvania
United States UPMC Camp Hill Camp Hill Pennsylvania
United States Cleveland Clinic Mercy Hospital Canton Ohio
United States Illinois CancerCare-Canton Canton Illinois
United States Saint Joseph Mercy Canton Canton Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Canton Canton Michigan
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Carlisle Regional Cancer Center Carlisle Pennsylvania
United States Illinois CancerCare-Carthage Carthage Illinois
United States Mercy Hospital Cedar Rapids Iowa
United States Oncology Associates at Mercy Medical Center Cedar Rapids Iowa
United States Centralia Oncology Clinic Centralia Illinois
United States WellSpan Medical Oncology and Hematology Chambersburg Pennsylvania
United States Medical University of South Carolina Charleston South Carolina
United States Ralph H Johnson VA Medical Center Charleston South Carolina
United States West Virginia University Charleston Division Charleston West Virginia
United States Saint Joseph Mercy Chelsea Chelsea Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea Michigan
United States Northwestern University Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States Medical Oncology and Hematology Associates-West Des Moines Clive Iowa
United States Mercy Cancer Center-West Lakes Clive Iowa
United States AdventHealth Infusion Center Haywood Clyde North Carolina
United States Columbus Oncology and Hematology Associates Inc Columbus Ohio
United States Doctors Hospital Columbus Ohio
United States Grant Medical Center Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States The Mark H Zangmeister Center Columbus Ohio
United States New Hampshire Oncology Hematology PA-Concord Concord New Hampshire
United States Mary Imogene Bassett Hospital Cooperstown New York
United States UPMC Hillman Cancer Center - Passavant - Cranberry Cranberry Township Pennsylvania
United States Greater Regional Medical Center Creston Iowa
United States Siteman Cancer Center at West County Hospital Creve Coeur Missouri
United States UPMC Western Maryland Cumberland Maryland
United States Parkland Memorial Hospital Dallas Texas
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Carle on Vermilion Danville Illinois
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Essentia Health - Deer River Clinic Deer River Minnesota
United States Delaware Health Center-Grady Cancer Center Delaware Ohio
United States Mission Cancer and Blood - Laurel Des Moines Iowa
United States Ascension Saint John Hospital Detroit Michigan
United States Illinois CancerCare-Dixon Dixon Illinois
United States Bayhealth Hospital Kent Campus Dover Delaware
United States Essentia Health Cancer Center Duluth Minnesota
United States Northside Hospital - Duluth Duluth Georgia
United States Duke University Medical Center Durham North Carolina
United States Durham VA Medical Center Durham North Carolina
United States Prisma Health Cancer Institute - Easley Easley South Carolina
United States Great Lakes Cancer Management Specialists-Doctors Park East China Township Michigan
United States Cancer Institute at Saint Francis Hospital East Hills New York
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States Arnot Ogden Medical Center/Falck Cancer Center Elmira New York
United States Ephrata Cancer Center Ephrata Pennsylvania
United States UPMC Hillman Cancer Center Erie Erie Pennsylvania
United States Illinois CancerCare-Eureka Eureka Illinois
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Roger Maris Cancer Center Fargo North Dakota
United States Parkland Health Center - Farmington Farmington Missouri
United States UPMC Cancer Center at UPMC Horizon Farrell Pennsylvania
United States Genesee Cancer and Blood Disease Treatment Center Flint Michigan
United States Genesee Hematology Oncology PC Flint Michigan
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Kaiser Permanente-Fontana Fontana California
United States McFarland Clinic PC-Trinity Cancer Center Fort Dodge Iowa
United States UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth Texas
United States Beebe South Coastal Health Campus Frankford Delaware
United States Palo Alto Medical Foundation-Fremont Fremont California
United States Unity Hospital Fridley Minnesota
United States Saint Luke's Cancer Institute - Fruitland Fruitland Idaho
United States Northeast Georgia Medical Center-Gainesville Gainesville Georgia
United States Kaiser Permanente-Gaithersburg Medical Center Gaithersburg Maryland
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Adams Cancer Center Gettysburg Pennsylvania
United States Addison Gilbert Hospital Gloucester Massachusetts
United States CTCA at Western Regional Medical Center Goodyear Arizona
United States Aurora Cancer Care-Grafton Grafton Wisconsin
United States Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin
United States Cone Health Cancer Center Greensboro North Carolina
United States UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg Pennsylvania
United States Oncology Hematology Associates Greenville Pennsylvania
United States Prisma Health Cancer Institute - Butternut Greenville South Carolina
United States Prisma Health Cancer Institute - Eastside Greenville South Carolina
United States Prisma Health Cancer Institute - Faris Greenville South Carolina
United States Prisma Health Greenville Memorial Hospital Greenville South Carolina
United States Prisma Health Cancer Institute - Greer Greer South Carolina
United States Academic Hematology Oncology Specialists Grosse Pointe Woods Michigan
United States Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods Michigan
United States Kaiser Permanente - Harbor City Harbor City California
United States UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg Pennsylvania
United States HaysMed University of Kansas Health System Hays Kansas
United States AdventHealth Hendersonville Hendersonville North Carolina
United States Essentia Health Hibbing Clinic Hibbing Minnesota
United States Edward Hines Jr VA Hospital Hines Illinois
United States Edwards Comprehensive Cancer Center Huntington West Virginia
United States IRMC Cancer Center Indiana Pennsylvania
United States Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana
United States Kaiser Permanente-Irvine Irvine California
United States University of Mississippi Medical Center Jackson Mississippi
United States Mercyhealth Hospital and Cancer Center - Janesville Janesville Wisconsin
United States McFarland Clinic PC-Jefferson Jefferson Iowa
United States UPMC-Johnstown/John P. Murtha Regional Cancer Center Johnstown Pennsylvania
United States Ascension Borgess Cancer Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Truman Medical Centers Kansas City Missouri
United States University of Kansas Cancer Center - North Kansas City Missouri
United States Kaiser Permanente - Kensington Medical Center Kensington Maryland
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States Northwestern Medicine Lake Forest Hospital Lake Forest Illinois
United States Sparrow Hospital Lansing Michigan
United States Kaiser Permanente - Largo Medical Center Largo Maryland
United States Memorial Medical Center - Las Cruces Las Cruces New Mexico
United States OptumCare Cancer Care at Charleston Las Vegas Nevada
United States OptumCare Cancer Care at Fort Apache Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Northside Hospital - Gwinnett Lawrenceville Georgia
United States Cancer Centers of Southwest Oklahoma Research Lawton Oklahoma
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States Sechler Family Cancer Center Lebanon Pennsylvania
United States University of Kansas Cancer Center - Lee's Summit Lee's Summit Missouri
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
United States Cedars Sinai Medical Center Los Angeles California
United States Kaiser Permanente Los Angeles Medical Center Los Angeles California
United States Kaiser Permanente West Los Angeles Los Angeles California
United States Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan
United States Illinois CancerCare-Macomb Macomb Illinois
United States University of Wisconsin Carbone Cancer Center Madison Wisconsin
United States Solinsky Center for Cancer Care Manchester New Hampshire
United States Cleveland Clinic Cancer Center Mansfield Mansfield Ohio
United States OhioHealth Marion General Hospital Marion Ohio
United States McFarland Clinic PC-Marshalltown Marshalltown Iowa
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Hillcrest Hospital Cancer Center Mayfield Heights Ohio
United States UPMC Cancer Center at UPMC McKeesport McKeesport Pennsylvania
United States Kaiser Permanente Tysons Corner Medical Center McLean Virginia
United States Cone Heath Cancer Center at Mebane Mebane North Carolina
United States UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg Pennsylvania
United States Froedtert Menomonee Falls Hospital Menomonee Falls Wisconsin
United States Saint Luke's Cancer Institute - Meridian Meridian Idaho
United States Mount Sinai Medical Center Miami Beach Florida
United States Bayhealth Hospital Sussex Campus Milford Delaware
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Aurora Sinai Medical Center Milwaukee Wisconsin
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Minneapolis VA Medical Center Minneapolis Minnesota
United States Memorial Medical Center Modesto California
United States UPMC Hillman Cancer Center - Monroeville Monroeville Pennsylvania
United States UPMC-Coraopolis/Heritage Valley Radiation Oncology Moon Pennsylvania
United States Virtua Samson Cancer Center Moorestown New Jersey
United States West Virginia University Healthcare Morgantown West Virginia
United States UPMC Hillman Cancer Center - Part of Frick Hospital Mount Pleasant Pennsylvania
United States Knox Community Hospital Mount Vernon Ohio
United States Arnold Palmer Cancer Center Medical Oncology Norwin N. Huntingdon Pennsylvania
United States Saint Luke's Cancer Institute - Nampa Nampa Idaho
United States UPMC Cancer Center-Natrona Heights Natrona Heights Pennsylvania
United States UPMC Hillman Cancer Center - New Castle New Castle Pennsylvania
United States Helen F Graham Cancer Center Newark Delaware
United States Licking Memorial Hospital Newark Ohio
United States Medical Oncology Hematology Consultants PA Newark Delaware
United States University of Kansas Cancer Center at North Kansas City Hospital North Kansas City Missouri
United States Ascension Providence Hospitals - Novi Novi Michigan
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States Kaiser Permanente-Oakland Oakland California
United States Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls Wisconsin
United States Mercy Hospital Oklahoma City Oklahoma City Oklahoma
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Olathe Health Cancer Center Olathe Kansas
United States Kaiser Permanente-Ontario Ontario California
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States University of Kansas Cancer Center-Overland Park Overland Park Kansas
United States University of Kansas Hospital-Indian Creek Campus Overland Park Kansas
United States Owensboro Health Mitchell Memorial Cancer Center Owensboro Kentucky
United States Palo Alto Medical Foundation Health Care Palo Alto California
United States Kaiser Permanente - Panorama City Panorama City California
United States Lahey Medical Center-Peabody Peabody Massachusetts
United States Illinois CancerCare-Pekin Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Temple University Hospital Philadelphia Pennsylvania
United States FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst North Carolina
United States University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania
United States UPMC-Mercy Hospital Pittsburgh Pennsylvania
United States UPMC-Passavant Hospital Pittsburgh Pennsylvania
United States UPMC-Saint Clair Hospital Cancer Center Pittsburgh Pennsylvania
United States Kaiser Permanente Northwest Portland Oregon
United States Oregon Health and Science University Portland Oregon
United States Southern Ohio Medical Center Portsmouth Ohio
United States Pottstown Hospital Pottstown Pennsylvania
United States Illinois CancerCare-Princeton Princeton Illinois
United States Duke Raleigh Hospital Raleigh North Carolina
United States Duke Women's Cancer Care Raleigh Raleigh North Carolina
United States Eisenhower Medical Center Rancho Mirage California
United States Beebe Health Campus Rehoboth Beach Delaware
United States Annie Penn Memorial Hospital Reidsville North Carolina
United States Renown Regional Medical Center Reno Nevada
United States UT Southwestern Clinical Center at Richardson/Plano Richardson Texas
United States Presbyterian Rust Medical Center/Jorgensen Cancer Center Rio Rancho New Mexico
United States Kaiser Permanente-Riverside Riverside California
United States University of Rochester Rochester New York
United States Mercyhealth Javon Bea Hospital - Rockton Rockford Illinois
United States Kaiser Permanente-Roseville Roseville California
United States Sutter Roseville Medical Center Roseville California
United States Kaiser Permanente Downtown Commons Sacramento California
United States Sutter Medical Center Sacramento Sacramento California
United States University of California Davis Comprehensive Cancer Center Sacramento California
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan
United States Marie Yeager Cancer Center Saint Joseph Michigan
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Siteman Cancer Center at Christian Hospital Saint Louis Missouri
United States Siteman Cancer Center-South County Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States Regions Hospital Saint Paul Minnesota
United States Siteman Cancer Center at Saint Peters Hospital Saint Peters Missouri
United States Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Salina Regional Health Center Salina Kansas
United States Kaiser Permanente-San Diego Zion San Diego California
United States California Pacific Medical Center-Pacific Campus San Francisco California
United States Kaiser Permanente-San Francisco San Francisco California
United States Veterans Affairs Medical Center - San Francisco San Francisco California
United States Kaiser Permanente-Santa Teresa-San Jose San Jose California
United States Kaiser Permanente San Leandro San Leandro California
United States Kaiser Permanente-San Marcos San Marcos California
United States Essentia Health Sandstone Sandstone Minnesota
United States North Coast Cancer Care Sandusky Ohio
United States MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford Sanford Maine
United States Kaiser Permanente Medical Center - Santa Clara Santa Clara California
United States Palo Alto Medical Foundation-Santa Cruz Santa Cruz California
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Prisma Health Cancer Institute - Seneca Seneca South Carolina
United States UPMC Cancer Center at UPMC Northwest Seneca Pennsylvania
United States Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Memorial Hospital of South Bend South Bend Indiana
United States Kaiser Permanente-South San Francisco South San Francisco California
United States Ascension Providence Hospitals - Southfield Southfield Michigan
United States Memorial Medical Center Springfield Illinois
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Springfield Regional Cancer Center Springfield Ohio
United States Springfield Regional Medical Center Springfield Ohio
United States Bhadresh Nayak MD PC-Sterling Heights Sterling Heights Michigan
United States Trinity's Tony Teramana Cancer Center Steubenville Ohio
United States Cleveland Clinic Cancer Center Strongsville Strongsville Ohio
United States Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay Wisconsin
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States Aurora Medical Center in Summit Summit Wisconsin
United States Palo Alto Medical Foundation-Sunnyvale Sunnyvale California
United States Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri
United States ProMedica Flower Hospital Sylvania Ohio
United States Ascension Saint Joseph Hospital Tawas City Michigan
United States University of Kansas Health System Saint Francis Campus Topeka Kansas
United States Torrance Memorial Physician Network - Cancer Care Torrance California
United States Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho
United States UPMC Cancer Center-Uniontown Uniontown Pennsylvania
United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States Kaiser Permanente-Vallejo Vallejo California
United States Sutter Solano Medical Center/Cancer Center Vallejo California
United States Essentia Health Virginia Clinic Virginia Minnesota
United States Virtua Voorhees Voorhees New Jersey
United States Kaiser Permanente-Walnut Creek Walnut Creek California
United States Great Lakes Cancer Management Specialists-Macomb Professional Building Warren Michigan
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States South Pointe Hospital Warrensville Heights Ohio
United States Illinois CancerCare - Washington Washington Illinois
United States Kaiser Permanente-Capitol Hill Medical Center Washington District of Columbia
United States UPMC Cancer Center-Washington Washington Pennsylvania
United States Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin
United States AdventHealth Infusion Center Weaverville Weaverville North Carolina
United States Aurora West Allis Medical Center West Allis Wisconsin
United States Froedtert West Bend Hospital/Kraemer Cancer Center West Bend Wisconsin
United States Mercy Medical Center-West Lakes West Des Moines Iowa
United States Veterans Affairs Connecticut Healthcare System-West Haven Campus West Haven Connecticut
United States Good Samaritan Hospital Medical Center West Islip New York
United States UPMC West Mifflin-Cancer Center Jefferson West Mifflin Pennsylvania
United States Saint Ann's Hospital Westerville Ohio
United States William E Kahlert Regional Cancer Center/Sinai Hospital Westminster Maryland
United States University of Kansas Hospital-Westwood Cancer Center Westwood Kansas
United States Presbyterian Intercommunity Hospital Whittier California
United States Ascension Via Christi Hospitals Wichita Wichita Kansas
United States Cancer Center of Kansas - Wichita Wichita Kansas
United States Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas
United States Divine Providence Hospital Williamsport Pennsylvania
United States Kaiser Permanente-Woodland Hills Woodland Hills California
United States Cleveland Clinic Wooster Family Health and Surgery Center Wooster Ohio
United States UMass Memorial Medical Center - University Campus Worcester Massachusetts
United States Cancer Care Associates of York York Pennsylvania
United States UPMC Memorial York Pennsylvania
United States WellSpan Health-York Cancer Center York Pennsylvania
United States WellSpan Health-York Hospital York Pennsylvania
United States Huron Gastroenterology PC Ypsilanti Michigan
United States Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti Michigan
United States Genesis Healthcare System Cancer Care Center Zanesville Ohio

Sponsors (2)

Lead Sponsor Collaborator
SWOG Cancer Research Network National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival Will be compared between the arms using the combination weighted/unweighted log-rank test statistic (as utilized in S1800A) with statistical significance at the 1-sided 10% level. Up to 2 years
Secondary Investigator-assessed progression-free survival (IA-PFS) Will be compared between the arms using the combination weighted/unweighted log-rank test statistic (as utilized in S1800A) with statistical significance at the 1-sided 10% level. From date of sub-study randomization to date of first documentation of potential immune-response confirmed progression, or death due to any cause, assessed up to 2 years
Secondary Duration of response (DoR) From date of first documentation of response (complete response or partial response) to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause, assessed up to 2 years
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