Clinical Trials

Study Overview

This study is looking at the benefits of combining two cancer treatments—chemotherapy and a specific immunotherapy called pembrolizumab—for older people with advanced lung cancer (stages IIIB to IV).

Immunotherapy like pembrolizumab works by boosting your body's immune system to help it fight the cancer. It can also block cancer cells from growing and spreading.

Chemotherapy uses different drugs to target and kill cancer cells, or stop them from dividing and spreading. However, chemotherapy is usually not targeted and often leads to many unwanted side effects associated with cancer treatment.

The goal is to evaluate the value of combining chemotherapy with immunotherapy in controlling lung cancer and if it leads to longer overall survival.

Trial identification number

NCT06096844

The medicine(s) being studied.

Chemotherapy + Pembrolizumab vs Pembrolizumab alone

How does the new medicine work (Mechanism of Action)?

All drugs are established and used widely. The goal is to find merit in adding the two in older adults.

What will be evaluated (Key endpoints)?

This study aims to find out if older adults with cancer live longer when treated with both chemotherapy and pembrolizumab, compared to just pembrolizumab alone.

Who may participate (Inclusion criteria)?

Age: You must be 70 years old or older.
Type of Cancer: You have non-small cell lung cancer.
Cancer Stage: Your cancer is at an advanced stage (IIIB, IIIC, or IV) and not suitable for combined chemo-radiation therapy. If you have had chemo-radiation before and the cancer came back, you can still join.
Cancer Markers: Your cancer must not have certain genetic markers (EGFR mutation/ALK translocations).
Health Status: Your overall health should allow only limited activity (ECOG Performance Status of 2).
Family Planning: If you can father children, you must agree not to during the study and for 6 months afterward.
Consent: You need to be able to understand and sign the consent form yourself, or have a legal representative who can consent for you if you are not able to make decisions yourself.
Blood Tests: Results from recent blood tests must meet specific criteria (details about blood cell counts, liver and kidney function).
Infections: If you have HIV or hepatitis, it must be well-controlled.
Other Cancers: If you have had another type of cancer, it must not affect this study.
Language: You must speak English or Spanish (for quality of life study part).

Additional Requirements Before Starting the Study

You must not have new or worsening symptoms from cancer spread to the brain.
You must not have received certain types of chemotherapy or immunotherapy for metastatic disease before.
- Investigator must declare their intended chemotherapy regimen should their patient be randomized to Arm B (doublet vs singlet)
Certain autoimmune conditions and the use of immunosuppressive medications are also considerations.

What Happens Next?

After you register and meet all these requirements, you will need to complete a baseline assessment before you can be randomly assigned to a treatment group in the study.

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Who may not participate (Exclusion criteria)?

List of participating clinical trials sites

Idaho Locations

Boise, Idaho, United States, 83706

Recruiting: Saint Alphonsus Cancer Care Center-Boise
Contact: Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Principal Investigator: John M. Schallenkamp

Caldwell, Idaho, United States, 83605

Recruiting: Saint Alphonsus Cancer Care Center-Caldwell
Contact: Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Principal Investigator: John M. Schallenkamp

Coeur d'Alene, Idaho, United States, 83814

Recruiting: Kootenai Health - Coeur d'Alene
Contact: Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
Principal Investigator: John M. Schallenkamp

Nampa, Idaho, United States, 83687

Recruiting: Saint Alphonsus Cancer Care Center-Nampa
Contact: Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
Principal Investigator: John M. Schallenkamp

Post Falls, Idaho, United States, 83854

Recruiting: Kootenai Clinic Cancer Services - Post Falls
Contact: Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
Principal Investigator: John M. Schallenkamp

Sandpoint, Idaho, United States, 83864

Recruiting: Kootenai Cancer Clinic
Contact: Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
Principal Investigator: John M. Schallenkamp

Illinois Locations

Chicago, Illinois, United States, 60612

Recruiting: University of Illinois
Contact: Site Public Contact, 312-355-3046
Principal Investigator: Frank Weinberg

Danville, Illinois, United States, 61832

Recruiting: Carle at The Riverfront
Contact: Site Public Contact, 800-446-5532, Research@Carle.com
Principal Investigator: Tanmay Sahai

Decatur, Illinois, United States, 62526

Recruiting: Cancer Care Specialists of Illinois - Decatur
Contact: Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Principal Investigator: Bryan A. Faller

Decatur, Illinois, United States, 62526

Recruiting: Decatur Memorial Hospital
Contact: Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Principal Investigator: Bryan A. Faller

Effingham, Illinois, United States, 62401

Recruiting: Carle Physician Group-Effingham
Contact: Site Public Contact, 800-446-5532, Research@carle.com
Principal Investigator: Tanmay Sahai

Effingham, Illinois, United States, 62401

Recruiting: Crossroads Cancer Center
Contact: Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Principal Investigator: Bryan A. Faller

Mattoon, Illinois, United States, 61938

Recruiting: Carle Physician Group-Mattoon/Charleston
Contact: Site Public Contact, 800-446-5532, Research@carle.com
Principal Investigator: Tanmay Sahai

Springfield, Illinois, United States, 62702

Recruiting: Southern Illinois University School of Medicine
Contact: Site Public Contact, 217-545-7929
Principal Investigator: Bryan A. Faller

Springfield, Illinois, United States, 62702

Recruiting: Springfield Clinic
Contact: Site Public Contact, 800-444-7541
Principal Investigator: Bryan A. Faller

Springfield, Illinois, United States, 62781

Recruiting: Memorial Medical Center
Contact: Site Public Contact, 217-528-7541, pallante.beth@mhsil.com
Principal Investigator: Bryan A. Faller

Urbana, Illinois, United States, 61801

Recruiting: Carle Cancer Center
Contact: Site Public Contact, 800-446-5532, Research@carle.com
Principal Investigator: Tanmay Sahai

Iowa Locations

Ankeny, Iowa, United States, 50023

Recruiting: Mission Cancer and Blood - Ankeny
Contact: Site Public Contact, 515-282-2921
Principal Investigator: Joshua Lukenbill

Cedar Rapids, Iowa, United States, 52403

Recruiting: Mercy Hospital
Contact: Site Public Contact, 319-365-4673
Principal Investigator: Deborah W. Wilbur

Cedar Rapids, Iowa, United States, 52403

Recruiting: Oncology Associates at Mercy Medical Center
Contact: Site Public Contact, 319-363-2690
Principal Investigator: Deborah W. Wilbur

Clive, Iowa, United States, 50325

Recruiting: Medical Oncology and Hematology Associates-West Des Moines
Contact: Site Public Contact, 515-241-3305
Principal Investigator: Richard L. Deming

Clive, Iowa, United States, 50325

Recruiting: Mercy Cancer Center-West Lakes
Contact: Site Public Contact, 515-358-6613, cancerresearch@mercydesmoines.org
Principal Investigator: Richard L. Deming

Des Moines, Iowa, United States, 50309

Recruiting: Medical Oncology and Hematology Associates-Des Moines
Contact: Site Public Contact, 515-241-3305
Principal Investigator: Joshua Lukenbill

Des Moines, Iowa, United States, 50314

Recruiting: Mercy Medical Center - Des Moines
Contact: Site Public Contact, 515-358-6613, cancerresearch@mercydesmoines.org
Principal Investigator: Richard L. Deming

Des Moines, Iowa, United States, 50314

Recruiting: Mission Cancer and Blood - Laurel
Contact: Site Public Contact, 515-241-3305
Principal Investigator: Richard L. Deming

Maryland Locations

Baltimore, Maryland, United States, 21215

Recruiting: Sinai Hospital of Baltimore
Contact: Site Public Contact, 410-601-6120, pridgely@lifebridgehealth.org
Principal Investigator: Vishal Jindal

Westminster, Maryland, United States, 21157

Recruiting: William E Kahlert Regional Cancer Center/Sinai Hospital
Contact: Site Public Contact, 410-871-6400
Principal Investigator: Vishal Jindal

Michigan Locations

Brighton, Michigan, United States, 48114

Recruiting: Trinity Health IHA Medical Group Hematology Oncology - Brighton
Contact: Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Principal Investigator: Christopher M. Reynolds

Canton, Michigan, United States, 48188

Recruiting: Trinity Health IHA Medical Group Hematology Oncology - Canton
Contact: Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Principal Investigator: Christopher M. Reynolds

Chelsea, Michigan, United States, 48118

Recruiting: Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Contact: Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Principal Investigator: Christopher M. Reynolds

Flint, Michigan, United States, 48503

Recruiting: Genesee Cancer and Blood Disease Treatment Center
Contact: Site Public Contact, 810-762-8038, wstrong@ghci.org
Principal Investigator: Christopher M. Reynolds

Flint, Michigan, United States, 48503

Recruiting: Genesee Hematology Oncology PC
Contact: Site Public Contact, 810-762-8038, wstrong@ghci.org
Principal Investigator: Christopher M. Reynolds

Flint, Michigan, United States, 48503

Recruiting: Genesys Hurley Cancer Institute
Contact: Site Public Contact, 810-762-8038, wstrong@ghci.org
Principal Investigator: Christopher M. Reynolds

Flint, Michigan, United States, 48503

Recruiting: Hurley Medical Center
Contact: Site Public Contact, 810-762-8038, wstrong@ghci.org
Principal Investigator: Christopher M. Reynolds

Lansing, Michigan, United States, 48912

Recruiting: University of Michigan Health - Sparrow Lansing
Contact: Site Public Contact, 517-364-3712, harsha.trivedi@umhsparrow.org
Principal Investigator: Christopher M. Reynolds

Livonia, Michigan, United States, 48154

Recruiting: Trinity Health Saint Mary Mercy Livonia Hospital
Contact: Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Principal Investigator: Christopher M. Reynolds

Pontiac, Michigan, United States, 48341

Recruiting: 21st Century Oncology-Pontiac
Contact: Site Public Contact, 248-858-6215, Emily.Crofts@trinity-health.org
Principal Investigator: Christopher M. Reynolds

Pontiac, Michigan, United States, 48341

Recruiting: Saint Joseph Mercy Oakland
Contact: Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Principal Investigator: Christopher M. Reynolds

Ypsilanti, Michigan, United States, 48197

Recruiting: Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Contact: Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Principal Investigator: Christopher M. Reynolds

Missouri Locations

Cape Girardeau, Missouri, United States, 63703

Recruiting: Saint Francis Medical Center
Contact: Site Public Contact, 573-334-2230, sfmc@sfmc.net
Principal Investigator: Bryan A. Faller

Osage Beach, Missouri, United States, 65065

Recruiting: Lake Regional Hospital
Contact: Site Public Contact, 573-302-2768, clinicaltrials@lakeregional.com
Principal Investigator: Jay W. Carlson

Montana Locations

Anaconda, Montana, United States, 59711

Recruiting: Community Hospital of Anaconda
Contact: Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
Principal Investigator: John M. Schallenkamp

Bozeman, Montana, United States, 59715

Recruiting: Bozeman Deaconess Hospital
Contact: Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
Principal Investigator: John M. Schallenkamp

Great Falls, Montana, United States, 59405

Recruiting: Benefis Healthcare- Sletten Cancer Institute
Contact: Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
Principal Investigator: John M. Schallenkamp

Missoula, Montana, United States, 59804

Recruiting: Community Medical Hospital
Contact: Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
Principal Investigator: John M. Schallenkamp

New York Locations

Bronx, New York, United States, 10461

Recruiting: Montefiore Medical Center-Einstein Campus
Contact: Site Public Contact, 718-379-6866, eskwak@montefiore.org
Principal Investigator: Balazs Halmos

Bronx, New York, United States, 10467

Recruiting: Montefiore Medical Center - Moses Campus
Contact: Site Public Contact, 718-379-6866, eskwak@montefiore.org
Principal Investigator: Balazs Halmos

Stony Brook, New York, United States, 11794

Recruiting: Stony Brook University Medical Center
Contact: Site Public Contact, 800-862-2215
Principal Investigator: Amna Sher

Ohio Locations

Belpre, Ohio, United States, 45714

Recruiting: Strecker Cancer Center-Belpre
Contact: Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Principal Investigator: Timothy D. Moore

Canton, Ohio, United States, 44710

Recruiting: Aultman Health Foundation
Contact: Site Public Contact, 330-363-7274, ClinicalReserachDept@aultman.com
Principal Investigator: Raza A. Khan

Centerville, Ohio, United States, 45459

Recruiting: Miami Valley Hospital South
Contact: Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Principal Investigator: Tarek M. Sabagh

Chillicothe, Ohio, United States, 45601

Recruiting: Adena Regional Medical Center
Contact: Site Public Contact, 877-779-7585, Jeffh@columbusccop.org
Principal Investigator: Timothy D. Moore

Cleveland, Ohio, United States, 44109

Recruiting: MetroHealth Medical Center
Contact: Site Public Contact, 216-778-7559, ababal@metrohealth.org
Principal Investigator: Peter Xie

Columbus, Ohio, United States, 43210

Recruiting: Ohio State University Comprehensive Cancer Center
Contact: Site Public Contact, 800-293-5066, Jamesline@osumc.edu
Principal Investigator: Carolyn J. Presley

Columbus, Ohio, United States, 43219

Recruiting: The Mark H Zangmeister Center
Contact: Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Principal Investigator: Timothy D. Moore

Dayton, Ohio, United States, 45409

Recruiting: Dayton Blood and Cancer Center
Contact: Site Public Contact, 937-276-8320
Principal Investigator: Tarek M. Sabagh

Dayton, Ohio, United States, 45409

Recruiting: Miami Valley Hospital
Contact: Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Principal Investigator: Tarek M. Sabagh

Dayton, Ohio, United States, 45415

Recruiting: Miami Valley Hospital North
Contact: Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Principal Investigator: Tarek M. Sabagh

Oregon Locations

Ontario, Oregon, United States, 97914

Recruiting: Saint Alphonsus Medical Center-Ontario
Contact: Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
Principal Investigator: John M. Schallenkamp

Pennsylvania Locations

Bryn Mawr, Pennsylvania, United States, 19010

Recruiting: Bryn Mawr Hospital
Contact: Site Public Contact, 484-476-2649, turzoe@mlhs.org
Principal Investigator: Deric C. Savior

Media, Pennsylvania, United States, 19063

Recruiting: Riddle Memorial Hospital
Contact: Site Public Contact, 484-476-2649, turzoe@mlhs.org
Principal Investigator: Deric C. Savior

Paoli, Pennsylvania, United States, 19301

Recruiting: Paoli Memorial Hospital
Contact: Site Public Contact, 484-476-2649, turzoe@mlhs.org
Principal Investigator: Deric C. Savior

Philadelphia, Pennsylvania, United States, 19103

Recruiting: ECOG-ACRIN Cancer Research Group
Contact: Megan A. Baumgart, megan_baumgart@urmc.rochester.edu
Principal Investigator: Megan A. Baumgart

West Reading, Pennsylvania, United States, 19611

Recruiting: Reading Hospital
Contact: Site Public Contact, 610-988-9323
Principal Investigator: Terrence P. Cescon

Wynnewood, Pennsylvania, United States, 19096

Recruiting: Lankenau Medical Center
Contact: Site Public Contact, 484-476-2649, turzoe@mlhs.org
Principal Investigator: Deric C. Savior

Virginia Locations

Richmond, Virginia, United States, 23235

Recruiting: VCU Massey Cancer Center at Stony Point
Contact: Site Public Contact, ctoclinops@vcu.edu
Principal Investigator: Jonathan D. Berkman

Richmond, Virginia, United States, 23298

Recruiting: Virginia Commonwealth University/Massey Cancer Center
Contact: Site Public Contact, CTOclinops@vcu.edu
Principal Investigator: Jonathan D. Berkman

Wisconsin Locations

Antigo, Wisconsin, United States, 54409

Recruiting: Langlade Hospital and Cancer Center
Contact: Site Public Contact, 715-623-9869, Juli.Alford@aspirus.org
Principal Investigator: Andrew J. Huang

Appleton, Wisconsin, United States, 54911

Recruiting: ThedaCare Regional Cancer Center
Contact: Site Public Contact, 920-364-3604, ResearchDept@thedacare.org
Principal Investigator: Matthias Weiss

Berlin, Wisconsin, United States, 54923

Recruiting: ThedaCare Cancer Care - Berlin
Contact: Site Public Contact, 920-364-3605, ResearchDept@thedacare.org
Principal Investigator: Matthias Weiss

La Crosse, Wisconsin, United States, 54601

Recruiting: Gundersen Lutheran Medical Center
Contact: Site Public Contact, 608-775-2385, cancerctr@gundersenhealth.org
Principal Investigator: Kurt Oettel

Medford, Wisconsin, United States, 54451

Recruiting: Aspirus Medford Hospital
Contact: Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org
Principal Investigator: Andrew J. Huang

Mukwonago, Wisconsin, United States, 53149

Recruiting: ProHealth D N Greenwald Center
Contact: Site Public Contact, research.institute@phci.org
Principal Investigator: Timothy R. Wassenaar

Neenah, Wisconsin, United States, 54956

Recruiting: ThedaCare Regional Medical Center - Neenah
Contact: Site Public Contact, 920-364-3605, ResearchDept@thedacare.org
Principal Investigator: Matthias Weiss

New London, Wisconsin, United States, 54961

Recruiting: ThedaCare Cancer Care - New London
Contact: Site Public Contact, 920-364-3605, ResearchDept@thedacare.org
Principal Investigator: Matthias Weiss

Oconomowoc, Wisconsin, United States, 53066

Recruiting: ProHealth Oconomowoc Memorial Hospital
Contact: Site Public Contact, 262-928-7878
Principal Investigator: Timothy R. Wassenaar

Oshkosh, Wisconsin, United States, 54904

Recruiting: ThedaCare Cancer Care - Oshkosh
Contact: Site Public Contact, 920-364-3605, ResearchDept@thedacare.org
Principal Investigator: Matthias Weiss

Rhinelander, Wisconsin, United States, 54501

Recruiting: Ascension Saint Mary's Hospital
Contact: Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org
Principal Investigator: Andrew J. Huang

Shawano, Wisconsin, United States, 54166

Recruiting: ThedaCare Cancer Care - Shawano
Contact: Site Public Contact, 920-364-3605, ResearchDept@thedacare.org
Principal Investigator: Matthias Weiss

Stevens Point, Wisconsin, United States, 54481

Recruiting: Ascension Saint Michael's Hospital
Contact: Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org
Principal Investigator: Andrew J. Huang

Waukesha, Wisconsin, United States, 53188

Recruiting: ProHealth Waukesha Memorial Hospital
Contact: Site Public Contact, 262-928-7632
Principal Investigator: Timothy R. Wassenaar

Waukesha, Wisconsin, United States, 53188

Recruiting: UW Cancer Center at ProHealth Care
Contact: Site Public Contact, 262-928-5539, Chanda.miller@phci.org
Principal Investigator: Timothy R. Wassenaar

Waupaca, Wisconsin, United States, 54981

Recruiting: ThedaCare Cancer Care - Waupaca
Contact: Site Public Contact, 920-364-3605, ResearchDept@thedacare.org
Principal Investigator: Matthias Weiss

Wausau, Wisconsin, United States, 54401

Recruiting: Aspirus Regional Cancer Center
Contact: Site Public Contact, 877-405-6866
Principal Investigator: Andrew J. Huang

Wisconsin Rapids, Wisconsin, United States, 54494

Recruiting: Aspirus Cancer Care - Wisconsin Rapids
Contact: Site Public Contact, 715-422-7718
Principal Investigator: Andrew J. Huang

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Any other information

This clinical trial is sponsored by the National Cancer Institute (NCI)

Link to clinicaltrials.gov

Chemotherapy + Immunotherapy vs Immunotherapy Alone for Older (>70yo) Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial

Idaho Locations

Illinois Locations

Iowa Locations

Maryland Locations

Michigan Locations

Missouri Locations

Montana Locations

New York Locations

Ohio Locations

Oregon Locations

Pennsylvania Locations

Virginia Locations

Wisconsin Locations