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Testing the Effects of MK-3475 (Pembrolizumab) with or without the Usual Chemotherapy Treatment for Patients 70 Years of Age and Older with Advanced Non-small Cell Lung Cancer

Trial Status: Active

This trial studies the side effects of pembrolizumab with or without chemotherapy in treating patients with stage IV non-small cell lung cancer that has come back (recurrent) and has spread to other places in the body (advanced). 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. Drugs used in chemotherapy, such as pemetrexed and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab with or without chemotherapy may shrink the tumor in older patients with non-small cell lung cancer.

Inclusion Criteria

  • Documentation of Disease: Histologic or cytologic diagnosis of non-small cell lung cancer (adenocarcinoma). Stage IV or recurrent metastatic non-small cell lung cancer. No planned initiation of definitive (potentially curative) concurrent chemo-radiation
  • Planning to begin MK-3475 (pembrolizumab) treatment within 14 days of registration, with or without combination chemotherapy. Treating physician considers pembrolizumab as appropriate and plans to proceed with one of the following treatment schedules: * MK-3475 (pembrolizumab) 200 mg IV flat dose every 21 days * MK-3475 (pembrolizumab) 200 mg IV + carboplatin area under the curve (AUC) = 5 + pemetrexed 500 mg/m^2 (20% chemotherapy dose reduction is permitted per the discretion of the treating physician)
  • Patients will be ineligible if they have an autoimmune disorder, are post-organ transplantation, or are receiving ongoing immunosuppression treatment
  • Prior adjuvant therapy is allowed and must have been completed at least 6 months prior to registration
  • No planned radiation or other cancer treatment in the 3 months following registration
  • No untreated brain metastases. Patients must be off corticosteroids and asymptomatic at registration
  • Absolute neutrophil count (ANC) >= 1500/mm^3 (1.5 x 10^9/L)
  • Platelet count: >= 100,000/mm^3 (100 x 10^9/L)
  • Creatinine >= 30 mL/min* for patients enrolled to pembrolizumab alone and > 45 mL/min for patients enrolled to chemotherapy + pembrolizumab * Calculated using the Cockcroft-Gault formula
  • Total serum bilirubin =< 1.5 upper limit of normal (ULN) (< 3 ULN if Gilbert's disease)
  • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =< 3 x ULN (=< 5.0 x ULN if liver metastases present)
  • Alkaline phosphatase =< 2.5 x ULN (=< 5 x ULN if bone or liver metastases present)
  • Language: Patients must be able to speak and comprehend English in order to complete the mandatory patient-completed measures

Alaska

Fairbanks
Fairbanks Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-458-3043

Arizona

Kingman
Kingman Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-9171

Colorado

Aurora
Rocky Mountain Cancer Centers-Aurora
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
The Medical Center of Aurora
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Boulder
Boulder Community Foothills Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Rocky Mountain Cancer Centers-Boulder
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Centennial
Rocky Mountain Cancer Centers - Centennial
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Colorado Springs
Penrose-Saint Francis Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Denver
Colorado Blood Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
National Jewish Health-Main Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-225-5654
Porter Adventist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Presbyterian - Saint Lukes Medical Center - Health One
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Rocky Mountain Cancer Centers-Midtown
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Rocky Mountain Cancer Centers-Rose
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
SCL Health Saint Joseph Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
The Women's Imaging Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Western Surgical Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Englewood
Mountain Blue Cancer Care Center - Swedish
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Swedish Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Golden
National Jewish Health-Western Hematology Oncology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 303-777-2663
Grand Junction
Saint Mary's Hospital and Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Greeley
North Colorado Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Lakewood
Saint Anthony Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Littleton
Littleton Adventist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Rocky Mountain Cancer Centers-Littleton
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Lone Tree
Rocky Mountain Cancer Centers-Sky Ridge
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Sky Ridge Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Longmont
Longmont United Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Loveland
McKee Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Parker
Parker Adventist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Pueblo
Saint Mary Corwin Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Thornton
National Jewish Health-Northern Hematology Oncology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 303-777-2663
Wheat Ridge
SCL Health Lutheran Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663

Florida

Clearwater
Morton Plant Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-314-8646
Plant City
South Florida Baptist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 813-707-2155
Saint Petersburg
Saint Anthony's Hospital Cancer Care Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 727-825-1139
Tampa
Saint Joseph's Hospital / Children's Hospital-Tampa
Status: ACTIVE
Contact: Site Public Contact
Phone: 813-357-0849
Winter Haven
Winter Haven Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-229-2273

Georgia

Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: ACTIVE
Contact: Site Public Contact
Phone: 912-819-5704

Illinois

Aurora
Rush - Copley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-978-6212
Centralia
Centralia Oncology Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Danville
Carle on Vermilion
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Decatur Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Effingham
Carle Physician Group-Effingham
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Crossroads Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Mount Vernon
Good Samaritan Regional Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 618-242-4600
O'Fallon
Cancer Care Center of O'Fallon
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Springfield
Memorial Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-788-3528
Southern Illinois University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-545-7929
Springfield Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-444-7541
Urbana
Carle Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
The Carle Foundation Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Yorkville
Rush-Copley Healthcare Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-978-6212

Iowa

Ames
Mary Greeley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
McFarland Clinic PC - Ames
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-239-4734
Boone
McFarland Clinic PC-Boone
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
Clive
Medical Oncology and Hematology Associates-West Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Mercy Cancer Center-West Lakes
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Creston
Greater Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Des Moines
Broadlawns Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-282-2200
Iowa Lutheran Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-241-8704
Iowa Methodist Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-241-6727
Medical Oncology and Hematology Associates-Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-282-2921
Medical Oncology and Hematology Associates-Laurel
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Mercy Medical Center - Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Fort Dodge
McFarland Clinic PC-Trinity Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
Trinity Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-574-8302
Jefferson
McFarland Clinic PC-Jefferson
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
Marshalltown
McFarland Clinic PC-Marshalltown
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
West Des Moines
Mercy Medical Center-West Lakes
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Methodist West Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-343-1000

Louisiana

New Orleans
Louisiana State University Health Science Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 504-210-3539
University Medical Center New Orleans
Status: ACTIVE
Contact: Site Public Contact
Phone: 504-210-3539

Maryland

Baltimore
Sinai Hospital of Baltimore
Status: ACTIVE
Contact: Site Public Contact
Phone: 410-601-6120
Randallstown
Northwest Hospital Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 410-601-4673
Westminster
William E Kahlert Regional Cancer Center / Sinai Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 410-871-6400

Michigan

Adrian
Hickman Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 517-265-0116
Grand Rapids
Mercy Health Saint Mary's
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Spectrum Health at Butterworth Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Muskegon
Mercy Health Mercy Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Norton Shores
Cancer and Hematology Centers of Western Michigan - Norton Shores
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Novi
Ascension Providence Hospitals - Novi
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-849-5332
Reed City
Spectrum Health Reed City Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Saint Joseph
Lakeland Medical Center Saint Joseph
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Marie Yeager Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Southfield
Ascension Providence Hospitals - Southfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-849-5332

Minnesota

Burnsville
Fairview Ridges Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Minnesota Oncology - Burnsville
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Cambridge
Cambridge Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Coon Rapids
Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Edina
Fairview Southdale Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Fridley
Unity Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Maple Grove
Fairview Clinics and Surgery Center Maple Grove
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Saint John's Hospital - Healtheast
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Minneapolis
Abbott-Northwestern Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Health Partners Inc
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Hennepin County Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Monticello
Monticello Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
New Ulm
New Ulm Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Princeton
Fairview Northland Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Robbinsdale
North Memorial Medical Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Saint Paul
Regions Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
United Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Shakopee
Saint Francis Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Stillwater
Lakeview Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Waconia
Ridgeview Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Willmar
Rice Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Woodbury
Minnesota Oncology Hematology PA-Woodbury
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Wyoming
Fairview Lakes Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517

Missouri

Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-251-7058
Cape Girardeau
Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Farmington
Parkland Health Center - Farmington
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Joplin
Freeman Health System
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-347-4030
Mercy Hospital Joplin
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-556-3074
Rolla
Mercy Clinic-Rolla-Cancer and Hematology
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-458-6379
Saint Joseph
Heartland Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 816-271-7937
Saint Louis
Mercy Hospital Saint Louis
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-251-7066
Missouri Baptist Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Saint Louis Cancer and Breast Institute-South City
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-353-1870
Siteman Cancer Center-South County
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Veteran's Affairs Medical Center - Saint Louis
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-9171
Washington University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Sullivan
Missouri Baptist Sullivan Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Washington
Mercy Hospital Washington
Status: ACTIVE
Contact: Site Public Contact
Phone: 636-390-1600

Montana

Billings
Billings Clinic Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-996-2663
Saint Vincent Frontier Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-648-6274
Saint Vincent Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Bozeman
Bozeman Deaconess Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Butte
Saint James Community Hospital and Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-723-2621
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Great Falls Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Kalispell
Kalispell Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Missoula
Saint Patrick Hospital - Community Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-327-3118

Nebraska

Omaha
Nebraska Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-354-5144

New Jersey

Mullica Hill
Inspira Medical Center Mullica Hill
Status: ACTIVE
Contact: Site Public Contact
Phone: 856-508-3500

New York

Auburn
Hematology Oncology Associates of Central New York-Auburn
Status: ACTIVE
Contact: Site Public Contact
Phone: 315-472-7504
East Syracuse
Hematology Oncology Associates of Central New York-East Syracuse
Status: ACTIVE
Contact: Site Public Contact
Phone: 315-472-7504
Glens Falls
Glens Falls Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 518-926-6700
Syracuse
Hematology Oncology Associates of Central New York-Onondaga Hill
Status: ACTIVE
Contact: Site Public Contact
Phone: 315-472-7504

North Carolina

Clinton
Southeastern Medical Oncology Center-Clinton
Status: ACTIVE
Contact: Site Public Contact
Phone: 919-587-9084
Goldsboro
Southeastern Medical Oncology Center-Goldsboro
Status: ACTIVE
Contact: Site Public Contact
Phone: 919-587-9084
Jacksonville
Southeastern Medical Oncology Center-Jacksonville
Status: ACTIVE
Contact: Site Public Contact
Phone: 910-587-9084
Kenansville
Vidant Oncology-Kenansville
Status: ACTIVE
Contact: Site Public Contact
Phone: 252-559-2201
Kinston
Vidant Oncology-Kinston
Status: ACTIVE
Contact: Site Public Contact
Phone: 252-559-2201
Richlands
Vidant Oncology-Richlands
Status: ACTIVE
Contact: Site Public Contact
Phone: 252-559-2201

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-293-5066
Toledo
Toledo Clinic Cancer Centers-Toledo
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-444-3561

Oklahoma

Oklahoma City
Mercy Hospital Oklahoma City
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-752-3402

Oregon

Corvallis
Good Samaritan Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 541-768-4352

Pennsylvania

Bryn Mawr
Bryn Mawr Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 484-476-2649
Collegeville
Main Line Health Center-Collegeville
Status: ACTIVE
Contact: Site Public Contact
Phone: 484-476-2649
Exton
Main Line Health Center-Exton
Status: ACTIVE
Contact: Site Public Contact
Phone: 484-476-2649
Media
Riddle Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 484-476-2649
Paoli
Paoli Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 484-476-2649
Wynnewood
Lankenau Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 484-476-2649

Rhode Island

Warwick
Kent Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 401-737-7010

South Carolina

Bluffton
Saint Joseph's / Candler - Bluffton Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 912-819-5704
Boiling Springs
Prisma Health Cancer Institute - Spartanburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Easley
Prisma Health Cancer Institute - Easley
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Greenville
Prisma Health Cancer Institute - Butternut
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Prisma Health Cancer Institute - Eastside
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Prisma Health Cancer Institute - Faris
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Greer
Prisma Health Cancer Institute - Greer
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Seneca
Prisma Health Cancer Institute - Seneca
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066

Texas

Bryan
Saint Joseph Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518

Virginia

Mechanicsville
Bon Secours Memorial Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 804-893-8663
Midlothian
Bon Secours Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 804-893-8663
Norfolk
Bon Secours DePaul Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 804-893-8663
Portsmouth
Bon Secours Maryview Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 804-893-8663
Richmond
Bon Secours Cancer Institute at Reynolds Crossing
Status: ACTIVE
Contact: Site Public Contact
Phone: 804-893-8663
Bon Secours Saint Mary's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 804-893-8663
Suffolk
Bon Secours Health Center at Harbour View
Status: ACTIVE
Contact: Site Public Contact
Phone: 804-893-8663

Washington

Port Townsend
Jefferson Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-344-3091
Walla Walla
Providence Saint Mary Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 509-897-5993

Wisconsin

La Crosse
Gundersen Lutheran Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 608-775-2385
Milwaukee
Medical College of Wisconsin
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-805-3666
Mukwonago
ProHealth D N Greenwald Center
Status: ACTIVE
Contact: Site Public Contact
New Richmond
Cancer Center of Western Wisconsin
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Oconomowoc
ProHealth Oconomowoc Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 262-928-7878
Waukesha
ProHealth Waukesha Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 262-928-7632
UW Cancer Center at ProHealth Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 262-928-5539

Wyoming

Cheyenne
Cheyenne Regional Medical Center-West
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Sheridan
Welch Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060

PRIMARY OBJECTIVE:

I. To estimate the adverse event profile of MK-3475 (pembrolizumab) over the first six months of treatment, in non-small cell lung cancer patients who are 70 years of age or older and who are treated with MK-3475 (pembrolizumab) +/- chemotherapy in a first-line setting.

SECONDARY OBJECTIVES:

I. To disaggregate the adverse events and identify potential causes of individual adverse events.

II. To estimate overall survival.

III. To describe patient quality of life during the treatment using the Linear Analogue Self-Assessment (LASA) questionnaire.

IV. To explore whether Comprehensive Geriatric Assessment (CGA) -derived risk score is able to predict rates of severe adverse events in older cancer patients who receive MK-3475 (pembrolizumab) or MK-3475 (pembrolizumab) + chemotherapy.

EXPLORATORY OBJECTIVES:

I. To describe patient fatigue level as measured with the Multidimensional Fatigue Symptom Inventory – Short Form (MFSI-SF); exercise level using the Godin Leisure Time Exercise Questionnaire (GLTE); and other symptoms and concerns using the LASA questionnaires.

II. To estimate time-to-treatment failure for single-agent MK-3475 (pembrolizumab) and MK-3475 (pembrolizumab) + chemotherapy in older patients.

CORRELATIVE SCIENCE OBJECTIVES:

I. To evaluate whether older patients who experience fatigue or other adverse effects would be correlated with a change of PD-L1 therapy-responsive T cell subset (i.e. CX3CR1+CD11ahighCD8+ T-cells) in their peripheral blood from baseline (prior to therapy) to post therapy.

II. To determine the extent to which MK-3475 (pembrolizumab) demonstrates time dependent decrease in clearance in older adult patients (aged >= 70 years) with non-small cell lung cancer being treated with pembrolizumab monotherapy or in combination with cytotoxic chemotherapy.

III. To determine the intrapatient and interpatient variability in clearance in older adult (>= 70 years) patients with non-small cell lung cancer receiving pembrolizumab monotherapy and when combined with cytotoxic chemotherapy.

IV. To preliminarily explore the correlation between pembrolizumab exposure (AUC) with observed immune related toxicities in this older adult (aged >= 70 years) patient population receiving pembrolizumab monotherapy and when combined with cytotoxic chemotherapy.

OUTLINE: Patients are assigned to 1 of 2 groups.

GROUP A: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 or 42 days in the absence of disease progression or unacceptable toxicity.

GROUP B: Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 or 42 days in the absence of disease progression or unacceptable toxicity. Patients also receive pemetrexed IV over 10 minutes, and carboplatin IV per institutional guidelines on day 1. Cycles with pemetrexed and carboplatin repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up annually for up to 5 years after registration.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Alliance for Clinical Trials in Oncology

Principal Investigator
Aminah Jatoi

  • Primary ID A171901
  • Secondary IDs NCI-2020-00544
  • Clinicaltrials.gov ID NCT04533451