AzTrials
AzTrials

Metastatic Lung AdenocarcinomaPhase 2NCT04533451

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

A Phase 2 study testing Pembrolizumab, Pemetrexed and Carboplatin in people with Metastatic Lung Adenocarcinoma and Metastatic Lung Non-Small Cell Carcinoma, run by Alliance for Clinical Trials in Oncology at 505 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study evaluates the side effects of pembrolizumab with or without chemotherapy in treating patients with stage IV non-small cell lung cancer that has come back after a period of improvement (recurrent) and may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body… Read more about this study

Who is it for?
Ages 70 years and older
What is being tested?
Pembrolizumab, Pemetrexed and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
505 sitesUnited States
Study dates
16 Nov 2020to 31 May 2027
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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 or 400 mg IV flat dose every 42 days.
  • MK-3475 (pembrolizumab) 200 mg IV/ 400 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 are post-organ transplantation, or are receiving ongoing immunosuppression treatment. Patients will be ineligible if they have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
  • Note: Replacement therapy (i.e., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Patients who require inhaled corticosteroids would not be excluded from the study. Patients with vitiligo or resolved childhood asthma/atopy would not be excluded from the study. Patients who require local steroid injections (for example, a steroid injection to a joint) would not be excluded from the study.
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  • 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 oral and IV corticosteroids for this condition and asymptomatic at registration
  • Age >= 70 years of age
  • Absolute neutrophil count (ANC) >= 1500/mm^3 (1.5 x 10^9/L)
  • Platelet count: >= 100,000/mm^3 (100 x 10^9/L)
  • Calculated creatinine clearance >= 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 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

Who cannot join

None listed.

Trial locations and contacts

505 sites in 1 country.

300 sites in 1 country

United States300 sites

  • Hickman Cancer Center

    Adrian, Michigan, 49221

  • Riverwood Healthcare Center

    Aitkin, Minnesota, 56431

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

  • Anchorage Associates in Radiation Medicine

    Anchorage, Alaska, 98508

  • Anchorage Radiation Therapy Center

    Anchorage, Alaska, 99504

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Mission Hope Medical Oncology - Arroyo Grande

    Arroyo Grande, California, 93420

  • PCR Oncology

    Arroyo Grande, California, 93420

  • AdventHealth Infusion Center Asheville

    Asheville, North Carolina, 28803

  • Duluth Clinic Ashland

    Ashland, Wisconsin, 54806

  • Northwest Wisconsin Cancer Center

    Ashland, Wisconsin, 54806

  • Hematology Oncology Associates of Central New York-Auburn

    Auburn, New York, 13021

  • Harold Alfond Center for Cancer Care

    Augusta, Maine, 04330

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • Saint Alphonsus Medical Center-Baker City

    Baker City, Oregon, 97814

  • Saint Louis Cancer and Breast Institute-Ballwin

    Ballwin, Missouri, 63011

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • Saint Agnes Hospital

    Baltimore, Maryland, 21229

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • Essentia Health - Baxter Clinic

    Baxter, Minnesota, 56425

  • Indu and Raj Soin Medical Center

    Beavercreek, Ohio, 45431

  • Nebraska Medicine-Bellevue

    Bellevue, Nebraska, 68123

  • Overlake Medical Center

    Bellevue, Washington, 98004

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889-5600

  • MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford

    Biddeford, Maine, 04005

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Saint Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • Saint Joseph's/Candler - Bluffton Campus

    Bluffton, South Carolina, 29910

  • Saint Elizabeth Boardman Hospital

    Boardman, Ohio, 44512

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

  • McFarland Clinic - Boone

    Boone, Iowa, 50036

  • Boulder Community Foothills Hospital

    Boulder, Colorado, 80303

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

  • United Hospital Center

    Bridgeport, West Virginia, 26330

  • Saint Joseph Mercy Brighton

    Brighton, Michigan, 48114

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

  • Saint Joseph Regional Cancer Center

    Bryan, Texas, 77802

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • Cambridge Medical Center

    Cambridge, Minnesota, 55008

  • Saint Joseph Mercy Canton

    Canton, Michigan, 48188

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • Saint Anthony Regional Hospital

    Carroll, Iowa, 51401

  • Carson Tahoe Regional Medical Center

    Carson City, Nevada, 89703

  • Physicians' Clinic of Iowa PC

    Cedar Rapids, Iowa, 52402

  • Rocky Mountain Cancer Centers - Centennial

    Centennial, Colorado, 80112

  • Dayton Physicians LLC-Miami Valley South

    Centerville, Ohio, 45459

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Saint Mary's Hospital

    Centralia, Illinois, 62801

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

  • Chambersburg Hospital

    Chambersburg, Pennsylvania, 17201

  • WellSpan Medical Oncology and Hematology

    Chambersburg, Pennsylvania, 17201

  • Saint Joseph Mercy Chelsea

    Chelsea, Michigan, 48118

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

  • Cancer Specialists of Tidewater Limited

    Chesapeake, Virginia, 23320

  • Cheyenne Regional Medical Center-West

    Cheyenne, Wyoming, 82001

  • Jesse Brown Veterans Affairs Medical Center

    Chicago, Illinois, 60612

  • University of Illinois

    Chicago, Illinois, 60612

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Marshfield Clinic-Chippewa Center

    Chippewa Falls, Wisconsin, 54729

  • Oncology Hematology Care Inc-Kenwood

    Cincinnati, Ohio, 45236

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

  • Hematology Oncology Consultants-Clarkston

    Clarkston, Michigan, 48346

  • Newland Medical Associates-Clarkston

    Clarkston, Michigan, 48346

  • Johnston Health Clayton

    Clayton, North Carolina, 27520

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Southeastern Medical Oncology Center-Clinton

    Clinton, North Carolina, 28328

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • AdventHealth Infusion Center Haywood

    Clyde, North Carolina, 28721

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

  • Main Line Health Center-Collegeville

    Collegeville, Pennsylvania, 19426

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Mount Carmel East Hospital

    Columbus, Ohio, 43213

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Grant Medical Center

    Columbus, Ohio, 43215

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Doctors Hospital

    Columbus, Ohio, 43228

  • New Hampshire Oncology Hematology PA-Concord

    Concord, New Hampshire, 03301

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Good Samaritan Hospital

    Corvallis, Oregon, 97330

  • Jennie Edmundson Memorial Hospital

    Council Bluffs, Iowa, 51502

  • Heartland Oncology and Hematology LLP

    Council Bluffs, Iowa, 51503

  • Greater Regional Medical Center

    Creston, Iowa, 50801

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

  • Dallas VA Medical Center

    Dallas, Texas, 75216

  • Carle at The Riverfront

    Danville, Illinois, 61832

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Dayton Physician LLC-Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Essentia Health - Deer River Clinic

    Deer River, Minnesota, 56636

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • National Jewish Health-Main Campus

    Denver, Colorado, 80206

  • The Women's Imaging Center

    Denver, Colorado, 80209

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Midtown

    Denver, Colorado, 80218

  • SCL Health Saint Joseph Hospital

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Rose

    Denver, Colorado, 80220

  • Rose Medical Center

    Denver, Colorado, 80220

  • Western Surgical Care

    Denver, Colorado, 80220

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Broadlawns Medical Center

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Mission Cancer and Blood - Laurel

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Ascension Saint John Hospital

    Detroit, Michigan, 48236

  • Essentia Health Saint Mary's - Detroit Lakes Clinic

    Detroit Lakes, Minnesota, 56501

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Great Lakes Cancer Management Specialists-Doctors Park

    East China, Michigan, 48054

  • Hematology Oncology Associates of Central New York-East Syracuse

    East Syracuse, New York, 13057

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • Mayo Clinic Health System-Eau Claire Clinic

    Eau Claire, Wisconsin, 54701

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Essentia Health - Ely Clinic

    Ely, Minnesota, 55731

  • Walter Knox Memorial Hospital

    Emmett, Idaho, 83617

  • Mountain Blue Cancer Care Center - Swedish

    Englewood, Colorado, 80113

  • Rocky Mountain Cancer Centers - Swedish

    Englewood, Colorado, 80113

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • The Melanoma and Skin Cancer Institute

    Englewood, Colorado, 80113

  • Ephrata Cancer Center

    Ephrata, Pennsylvania, 17522

  • Ephrata Community Hospital

    Ephrata, Pennsylvania, 17522

  • Main Line Health Center-Exton

    Exton, Pennsylvania, 19341

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

  • Essentia Health Cancer Center-South University Clinic

    Fargo, North Dakota, 58103

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

  • Lake Region Healthcare Corporation-Cancer Care

    Fergus Falls, Minnesota, 56537

  • Armes Family Cancer Center

    Findlay, Ohio, 45840

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Orion Cancer Care

    Findlay, Ohio, 45840

  • Genesee Cancer and Blood Disease Treatment Center

    Flint, Michigan, 48503

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • McFarland Clinic - Trinity Cancer Center

    Fort Dodge, Iowa, 50501

  • Trinity Regional Medical Center

    Fort Dodge, Iowa, 50501

  • Essentia Health - Fosston

    Fosston, Minnesota, 56542

  • Beebe South Coastal Health Campus

    Frankford, Delaware, 19945

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Dayton Physicians LLC-Atrium

    Franklin, Ohio, 45005

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

  • Tidelands Georgetown Memorial Hospital

    Georgetown, South Carolina, 29440

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Glens Falls Hospital

    Glens Falls, New York, 12801

  • Peninsula Cancer Institute-Gloucester

    Gloucester, Virginia, 23061

  • National Jewish Health-Western Hematology Oncology

    Golden, Colorado, 80401

  • Southeastern Medical Oncology Center-Goldsboro

    Goldsboro, North Carolina, 27534

  • CHI Health Saint Francis

    Grand Island, Nebraska, 68803

  • Saint Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado, 81501

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Dayton Physicians LLC-Wayne

    Greenville, Ohio, 45331

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Academic Hematology Oncology Specialists

    Grosse Pointe Woods, Michigan, 48236

  • Great Lakes Cancer Management Specialists-Van Elslander Cancer Center

    Grosse Pointe Woods, Michigan, 48236

  • Michigan Breast Specialists-Grosse Pointe Woods

    Grosse Pointe Woods, Michigan, 48236

  • Mount Carmel Grove City Hospital

    Grove City, Ohio, 43123

  • Zangmeister Center Grove City

    Grove City, Ohio, 43123

  • Cherry Tree Cancer Center

    Hanover, Pennsylvania, 17331

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Essentia Health-Hayward Clinic

    Hayward, Wisconsin, 54843

  • Cancer and Blood Specialists-Henderson

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada - Henderson

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada-Horizon Ridge

    Henderson, Nevada, 89052

  • Las Vegas Cancer Center-Henderson

    Henderson, Nevada, 89052

  • OptumCare Cancer Care at Seven Hills

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada-Southeast Henderson

    Henderson, Nevada, 89074

  • GenesisCare USA - Henderson

    Henderson, Nevada, 89074

  • Las Vegas Urology - Green Valley

    Henderson, Nevada, 89074

  • Las Vegas Urology - Pebble

    Henderson, Nevada, 89074

  • Urology Specialists of Nevada - Green Valley

    Henderson, Nevada, 89074

  • Maria Parham Hospital

    Henderson, North Carolina, 27536

  • AdventHealth Hendersonville

    Hendersonville, North Carolina, 28792

  • Essentia Health Hibbing Clinic

    Hibbing, Minnesota, 55746

  • South Carolina Cancer Specialists PC

    Hilton Head Island, South Carolina, 29926-3827

  • Essentia Health - International Falls Clinic

    International Falls, Minnesota, 56649

  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington, 98029

  • Southeastern Medical Oncology Center-Jacksonville

    Jacksonville, North Carolina, 28546

  • Essentia Health - Jamestown Clinic

    Jamestown, North Dakota, 58401

  • McFarland Clinic - Jefferson

    Jefferson, Iowa, 50129

  • Duly Health and Care Joliet

    Joliet, Illinois, 60435

  • Freeman Health System

    Joplin, Missouri, 64804

  • Mercy Hospital Joplin

    Joplin, Missouri, 64804

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Ascension Borgess Cancer Center

    Kalamazoo, Michigan, 49009

  • Borgess Medical Center

    Kalamazoo, Michigan, 49048

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Vidant Oncology-Kenansville

    Kenansville, North Carolina, 28349

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

  • Greater Dayton Cancer Center

    Kettering, Ohio, 45409

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Kingman Regional Medical Center

    Kingman, Arizona, 86401

  • Vidant Oncology-Kinston

    Kinston, North Carolina, 28501

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Mayo Clinic Health System-Franciscan Healthcare

    La Crosse, Wisconsin, 54601

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Marshfield Clinic - Ladysmith Center

    Ladysmith, Wisconsin, 54848

  • Rocky Mountain Cancer Centers-Lakewood

    Lakewood, Colorado, 80228

  • Saint Anthony Hospital

    Lakewood, Colorado, 80228

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • Las Vegas Urology - Pecos

    Las Vegas, Nevada, 89074

  • Desert West Surgery

    Las Vegas, Nevada, 89102

  • OptumCare Cancer Care at Charleston

    Las Vegas, Nevada, 89102

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Hope Cancer Care of Nevada

    Las Vegas, Nevada, 89103

  • Radiation Oncology Centers of Nevada Central

    Las Vegas, Nevada, 89106

  • Urology Specialists of Nevada - Central

    Las Vegas, Nevada, 89106

  • GenesisCare USA - Las Vegas

    Las Vegas, Nevada, 89109

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada, 89109

  • Las Vegas Prostate Cancer Center

    Las Vegas, Nevada, 89113

  • Las Vegas Urology - Sunset

    Las Vegas, Nevada, 89113

  • Urology Specialists of Nevada - Southwest

    Las Vegas, Nevada, 89113

  • Radiation Oncology Centers of Nevada Southeast

    Las Vegas, Nevada, 89119

  • Ann M Wierman MD LTD

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Centers of Nevada - Northwest

    Las Vegas, Nevada, 89128

  • GenesisCare USA - Vegas Tenaya

    Las Vegas, Nevada, 89128

  • Las Vegas Urology - Cathedral Rock

    Las Vegas, Nevada, 89128

  • Las Vegas Urology - Smoke Ranch

    Las Vegas, Nevada, 89128

  • OptumCare Cancer Care at MountainView

    Las Vegas, Nevada, 89128

  • Urology Specialists of Nevada - Northwest

    Las Vegas, Nevada, 89128

  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation

    Las Vegas, Nevada, 89135

  • Comprehensive Cancer Centers of Nevada - Town Center

    Las Vegas, Nevada, 89144

  • Comprehensive Cancer Centers of Nevada-Summerlin

    Las Vegas, Nevada, 89144

  • Summerlin Hospital Medical Center

    Las Vegas, Nevada, 89144

  • Las Vegas Cancer Center-Medical Center

    Las Vegas, Nevada, 89148-2405

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

  • GenesisCare USA - Fort Apache

    Las Vegas, Nevada, 89148

  • OptumCare Cancer Care at Fort Apache

    Las Vegas, Nevada, 89148

  • Comprehensive Cancer Centers of Nevada - Central Valley

    Las Vegas, Nevada, 89169

  • University Cancer Center

    Las Vegas, Nevada, 89169

  • Scotland Memorial Hospital-Laurinburg Cancer Center

    Laurinburg, North Carolina, 28352

  • Sechler Family Cancer Center

    Lebanon, Pennsylvania, 17042

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Rocky Mountain Cancer Centers-Littleton

    Littleton, Colorado, 80120

  • Littleton Adventist Hospital

    Littleton, Colorado, 80122

  • Hope Cancer Clinic

    Livonia, Michigan, 48154

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • Rocky Mountain Cancer Centers-Sky Ridge

    Lone Tree, Colorado, 80124

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Longmont United Hospital

    Longmont, Colorado, 80501

  • McKee Medical Center

    Loveland, Colorado, 80539

  • Southeastern Regional Medical Center

    Lumberton, North Carolina, 28358

  • Centra Lynchburg Hematology-Oncology Clinic Inc

    Lynchburg, Virginia, 24501

  • Great Lakes Cancer Management Specialists-Macomb Medical Campus

    Macomb, Michigan, 48044

  • Michigan Breast Specialists-Macomb Township

    Macomb, Michigan, 48044

  • Solinsky Center for Cancer Care

    Manchester, New Hampshire, 03103

  • Fairview Clinics and Surgery Center Maple Grove

    Maple Grove, Minnesota, 55369

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • McFarland Clinic - Marshalltown

    Marshalltown, Iowa, 50158

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • WVUH-Berkely Medical Center

    Martinsburg, West Virginia, 25401

  • Toledo Clinic Cancer Centers-Maumee

    Maumee, Ohio, 43537

Other trials in United States

About this study

Official title: Older Non-Small Cell Lung Cancer Patients (>/= 70 Years of Age) Treated With First-Line MK-3475 (Pembrolizumab)+/- Chemotherapy (Oncologist's/Patient's Choice)

This study evaluates the side effects of pembrolizumab with or without chemotherapy in treating patients with stage IV non-small cell lung cancer that has come back after a period of improvement (recurrent) and may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of 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.

Read the detailed description

The primary and secondary objectives of the study:

PRIMARY OBJECTIVE:

  1. 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:

  1. To estimate overall survival. II. To describe patient quality of life during the treatment using the Linear Analogue Self-Assessment (LASA) questionnaire.

III. 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.

OUTLINE: This is an observational study. 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. Additionally, patients complete questionnaires as well as undergo computed tomography (CT) scan, diagnostic imaging, and blood sample collection throughout the study. Patients also complete a geriatric assessment on study.

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. Additionally, patients complete questionnaires as well as undergo CT scan, diagnostic imaging, and blood sample collection throughout the study. Patients also complete a geriatric assessment on study.

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

Being tested
Pembrolizumab, Pemetrexed, Carboplatin, Comprehensive Geriatric Assessment, Questionnaire Administration
Medical subject headings
Adenocarcinoma of Lung, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabDrug

    Given IV

  • PemetrexedDrug

    Given IV

  • CarboplatinDrug

    Given IV

  • Comprehensive Geriatric AssessmentOther

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • Quality-of-Life AssessmentOther

    Ancillary studies

Study groups in NCT04533451
Study groupRoleWhat they receive
Group A (pembrolizumab)ExperimentalPatients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 or 42 days in the absence of disease progression or unacceptable toxicity. Additionally, patients complete questionnaires as well as undergo CT scan, diagnostic imaging, and blood sample collection throughout the study. Patients also complete a geriatric assessment on study.
Receives: Drug: Pembrolizumab; Other: Comprehensive Geriatric Assessment; Other: Questionnaire Administration; Other: Quality-of-Life Assessment
Group B (pembrolizumab, pemetrexed, carboplatin)ExperimentalPatients 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. Additionally, patients complete questionnaires as well as undergo CT scan, diagnostic imaging, and blood sample collection throughout the study. Patients also complete a geriatric assessment on study.
Receives: Drug: Pembrolizumab; Drug: Pemetrexed; Drug: Carboplatin; Other: Comprehensive Geriatric Assessment; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Grade 3 or Worse Adverse Events Post Registration

    Assessed by National Cancer Institute Common Terminology Criteria in Adverse Events version 5.0. The proportion of patients experience grade 3 or worse adverse events (AEs) will be summarized by frequency and percentage along with a 95% confidence interval (CI) separately by type of therapy (monotherapy or combination therapy) as well as combining the two cohorts. All other individual AEs will be analyzed in an exploratory and hypothesis generating manner; including and not limited to multi-variate logistic regression models considering the baseline demographics and the presence/absence of the AE.

    Measured: Up to 7 days of last day of treatment, up to 6 months

Secondary outcomes (3)

  1. Overall Survival (OS)

    Will be summarized using the Kaplan-Meier estimator, separately by monotherapy or combination therapy as well as by the combined cohort.

    Measured: From study registration to death or the last follow-up whichever occurs first, assessed up to 3 years

  2. Quality of Life (QOL): Linear Analogue Self-Assessment [LASA] Questionnaire

    The overall quality of life score (the first question of the Linear Analogue Self-Assessment [LASA] questionnaire) at each time point as well as change from baseline will be summarized by mean (standard deviation), median (range) along with a longitudinal plot. The median quality of life (QOL) change from baseline along with a 95% confidence interval (CI) will be estimated using the Hodges-Lehmann method. The overall quality of life score will be measured on a scale from 0-10, with higher being better.

    Measured: Up to 9 weeks

  3. Comprehensive Geriatric Assessment Risk Score

    The geriatric risk score, measured as low, medium, or high, will be summarized in a 3X2 frequency table with adverse events.

    Measured: At baseline. Per the protocol section 13.5,Comprehensive geriatric assessment would be examined combined by arm.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2020
  2. Study start16 Nov 2020
  3. Primary completion31 Oct 2023
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04533451
Sponsor's protocol ID
A171901
Other IDs
NCI-2020-00544, UG1CA189823
Status last verified
Sep 2026
First submitted
19 Aug 2020
Last updated
8 Oct 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Wong ML, Lee MK, Kour O, Satele D, Presley CJ, Le-Rademacher J, Ojelabi M, Chow S, Stinchcombe TE, Homan S, Finnes HD, Waqar S, Jatoi A. Pembrolizumab with or without chemotherapy among older adults with advanced lung adenocarcinoma: a national, nonrandomized open-label phase II trial (Alliance A171901). J Natl Cancer Inst. 2026 May 20:djag157. doi: 10.1093/jnci/djag157. Online ahead of print.

    PubMed 42161344

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab, Pemetrexed and Carboplatin in people with Metastatic Lung Adenocarcinoma and Metastatic Lung Non-Small Cell Carcinoma, run by Alliance for Clinical Trials in Oncology at 505 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 505 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Grade 3 or Worse Adverse Events Post Registration (time frame: Up to 7 days of last day of treatment, up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04533451, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.

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