Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial
Launched by NATIONAL CANCER INSTITUTE (NCI) · Oct 21, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
The ACHIEVE Trial is a clinical study designed to find out if combining chemotherapy with an immunotherapy drug called pembrolizumab is more effective than using immunotherapy alone for older adults with advanced lung cancer (specifically, stage IIIB to IV non-small cell lung cancer). Immunotherapy helps the body's immune system fight cancer, while chemotherapy aims to kill cancer cells or stop them from growing. This trial is looking for patients aged 70 and older who have been diagnosed with this type of lung cancer and meet specific health criteria to see if the combination treatment can help stabilize their condition better than immunotherapy by itself.
To participate in the trial, patients need to have confirmed lung cancer that is not caused by certain genetic mutations and must not have had prior chemotherapy or immunotherapy for metastatic disease. They should also be in generally good health with specific blood test results. Those who enter the trial can expect to receive either the combination treatment or immunotherapy alone and will be closely monitored throughout the study. This trial is an important step in understanding the best treatment options for older adults facing advanced lung cancer.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • STEP 1 REGISTRATION
- • Patient must be ≥ 70 years of age
- • Patient must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with PD-L1 Tumor Proportion Score (TPS) range of 1-49%
- • Patient must have Stage IIIB, IIIC or IV disease and not be candidates for combined chemo-radiation. NOTE: Prior chemo-radiation therapy (RT) for stage III with recurrence is allowed
- • Patient must have a tumor that is negative for EGFR mutation/ALK translocations or other actionable first line mutations in which patients would receive first-line oral tyrosine kinase inhibitors
- • Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 2
- • Patient must agree not to father children while on study and for 6 months after the last dose of protocol treatment
- • Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
- • Absolute neutrophil count (ANC) ≥ 1,500/uL (obtained within 14 days prior to Step 1 registration)
- • Platelets ≥ 75,000/uL (obtained within 14 days prior to Step 1 registration)
- • Hemoglobin (Hgb) ≥ 8.0 g/dL (obtained within 14 days prior to Step 1 registration)
- • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (obtained within 14 days prior to Step 1 registration)
- • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 3.0 × institutional ULN (obtained within 14 days prior to Step 1 registration)
- • Creatinine clearance (CrCL) ≥ 45 mL/min (estimated using Cockcroft-Gault method with actual body weight or measured) (obtained within 14 days prior to Step 1 registration)
- • Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months of Step 1 registration are eligible for this trial
- • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have undetectable HCV viral
- • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- • Patient must be English or Spanish speaking to be eligible for the QOL component of the study
- • NOTE: Sites cannot translate the associated GA or QOL forms
- • Patient must not have symptomatic central nervous system disease (CNS) metastases. Patients with a clinical history of CNS metastases or cord compression are eligible if they have been definitively treated and are clinically stable for at least 14 days prior to Step 1 registration and off all steroids for at least 24 hours prior to Step 1 registration. Patients with asymptomatic CNS metastases are eligible
- • Patient must not have had any prior cytotoxic chemotherapy regimen for metastatic disease. Chemotherapy given in the setting of adjuvant therapy or locally advanced disease is allowed as long as treatment was completed, and they have fully recovered from treatment related adverse events prior to Step 1 registration
- • Patient must not have had any prior immunotherapy for metastatic disease. Immunotherapy given in the setting of adjuvant therapy or locally advanced disease is allowed as long as treatment was completed greater than 6 months prior to Step 1 registration
- • Patient must not have a history of uncontrolled autoimmune conditions with the following exceptions, which are allowed: alopecia, vitiligo, rheumatoid arthritis, psoriasis/psoriatic arthritis, Hashimoto's thyroiditis, lupus, inflammatory bowel disease
- • Patient must not be on immunosuppressive medication, including steroids (if doses exceed the equivalent of prednisone 10 mg daily). Short courses of steroids which are discontinued prior to randomization are acceptable. Patients on inhaled, intranasal and/or topical steroids are eligible
- • Patient must have baseline imaging done assessing all measurable or non-measurable sites of disease within 45 days prior to Step 1 registration
- • Investigator must declare their intended chemotherapy regimen should their patient be randomized to Arm B (doublet versus\[vs\] singlet)
- • STEP 2 RANDOMIZATION
- • Patient must have completed the baseline Geriatric Assessment (GA) after Step 1 registration and prior to Step 2 randomization
About National Cancer Institute (Nci)
The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cleveland, Ohio, United States
Charleston, South Carolina, United States
Saint Louis, Missouri, United States
Flint, Michigan, United States
Flint, Michigan, United States
Kalamazoo, Michigan, United States
Edina, Minnesota, United States
Maywood, Illinois, United States
La Crosse, Wisconsin, United States
Cleveland, Ohio, United States
Baltimore, Maryland, United States
Saint Paul, Minnesota, United States
Kalamazoo, Michigan, United States
Traverse City, Michigan, United States
Bozeman, Montana, United States
Kalispell, Montana, United States
Charlottesville, Virginia, United States
Dallas, Texas, United States
Mount Vernon, Illinois, United States
Salina, Kansas, United States
Chillicothe, Ohio, United States
Bryn Mawr, Pennsylvania, United States
Coon Rapids, Minnesota, United States
Urbana, Illinois, United States
Minneapolis, Minnesota, United States
Saint Paul, Minnesota, United States
Shakopee, Minnesota, United States
Dayton, Ohio, United States
Rapid City, South Dakota, United States
Effingham, Illinois, United States
Lawrence, Kansas, United States
Mount Vernon, Ohio, United States
Fayetteville, Arkansas, United States
Springfield, Illinois, United States
Downers Grove, Illinois, United States
Hazel Crest, Illinois, United States
Springfield, Illinois, United States
Media, Pennsylvania, United States
Tampa, Florida, United States
Rochester, New York, United States
Philadelphia, Pennsylvania, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Duluth, Minnesota, United States
Syracuse, New York, United States
Syracuse, New York, United States
Bismarck, North Dakota, United States
Fargo, North Dakota, United States
Columbus, Ohio, United States
Wynnewood, Pennsylvania, United States
Aurora, Illinois, United States
Bronx, New York, United States
Canton, Ohio, United States
Cape Girardeau, Missouri, United States
Saint Louis Park, Minnesota, United States
Louisville, Kentucky, United States
Milwaukee, Wisconsin, United States
Fort Lauderdale, Florida, United States
Oak Lawn, Illinois, United States
Oakland, California, United States
Miami, Florida, United States
Park Ridge, Illinois, United States
Stony Brook, New York, United States
Sioux Falls, South Dakota, United States
Dallas, Texas, United States
Richmond, Virginia, United States
Bronx, New York, United States
Marshfield, Wisconsin, United States
Palo Alto, California, United States
Durham, North Carolina, United States
Decatur, Illinois, United States
Cedar Rapids, Iowa, United States
Cedar Rapids, Iowa, United States
Clive, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Lansing, Michigan, United States
Pontiac, Michigan, United States
Great Falls, Montana, United States
Sayre, Pennsylvania, United States
Paoli, Pennsylvania, United States
Phoenixville, Pennsylvania, United States
Fremont, California, United States
Roseville, California, United States
Sacramento, California, United States
San Francisco, California, United States
San Jose, California, United States
San Leandro, California, United States
Santa Clara, California, United States
Santa Rosa, California, United States
South San Francisco, California, United States
Vallejo, California, United States
Walnut Creek, California, United States
Kansas City, Kansas, United States
Topeka, Kansas, United States
Worcester, Massachusetts, United States
Battle Creek, Michigan, United States
Bemidji, Minnesota, United States
Billings, Montana, United States
Missoula, Montana, United States
Mullica Hill, New Jersey, United States
Dayton, Ohio, United States
Franklin, Ohio, United States
Mentor, Ohio, United States
Toledo, Ohio, United States
Troy, Ohio, United States
Philadelphia, Pennsylvania, United States
West Reading, Pennsylvania, United States
Sioux Falls, South Dakota, United States
Oconomowoc, Wisconsin, United States
Rhinelander, Wisconsin, United States
Rice Lake, Wisconsin, United States
Sheboygan, Wisconsin, United States
Stevens Point, Wisconsin, United States
Waukesha, Wisconsin, United States
West Allis, Wisconsin, United States
Weston, Wisconsin, United States
Stamford, Connecticut, United States
Newark, Ohio, United States
Zanesville, Ohio, United States
Huntington, West Virginia, United States
Antigo, Wisconsin, United States
Wausau, Wisconsin, United States
Libertyville, Illinois, United States
Livonia, Michigan, United States
Oshkosh, Wisconsin, United States
Munster, Indiana, United States
Pensacola, Florida, United States
Kansas City, Missouri, United States
Elgin, Illinois, United States
Honolulu, Hawaii, United States
Boise, Idaho, United States
Appleton, Wisconsin, United States
Philadelphia, Pennsylvania, United States
Grafton, Wisconsin, United States
Fort Smith, Arkansas, United States
Post Falls, Idaho, United States
Chicago, Illinois, United States
Methuen, Massachusetts, United States
Mankato, Minnesota, United States
Saint Louis, Missouri, United States
Burlington, Wisconsin, United States
Germantown, Wisconsin, United States
Green Bay, Wisconsin, United States
Kenosha, Wisconsin, United States
Marinette, Wisconsin, United States
Milwaukee, Wisconsin, United States
Racine, Wisconsin, United States
Summit, Wisconsin, United States
Two Rivers, Wisconsin, United States
Wauwatosa, Wisconsin, United States
Wisconsin Rapids, Wisconsin, United States
Olathe, Kansas, United States
Saint Louis, Missouri, United States
Plainsboro, New Jersey, United States
Oklahoma City, Oklahoma, United States
Fresno, California, United States
Modesto, California, United States
Overland Park, Kansas, United States
Kansas City, Missouri, United States
Lee's Summit, Missouri, United States
Fargo, North Dakota, United States
Beachwood, Ohio, United States
Columbus, Ohio, United States
Edmonds, Washington, United States
Issaquah, Washington, United States
Eau Claire, Wisconsin, United States
Rogers, Arkansas, United States
Springfield, Illinois, United States
Belpre, Ohio, United States
Springfield, Ohio, United States
Saint Peters, Missouri, United States
Great Falls, Montana, United States
Caldwell, Idaho, United States
Coeur D'alene, Idaho, United States
Sandpoint, Idaho, United States
Clive, Iowa, United States
Flint, Michigan, United States
Flint, Michigan, United States
Pontiac, Michigan, United States
Saginaw, Michigan, United States
West Branch, Michigan, United States
Anaconda, Montana, United States
Centerville, Ohio, United States
Grove City, Ohio, United States
Ontario, Oregon, United States
Decatur, Illinois, United States
Effingham, Illinois, United States
Mattoon, Illinois, United States
O'fallon, Illinois, United States
Louisville, Kentucky, United States
Brighton, Michigan, United States
Canton, Michigan, United States
Chelsea, Michigan, United States
Ypsilanti, Michigan, United States
Milford, Massachusetts, United States
Richmond, Virginia, United States
Dublin, California, United States
Sacramento, California, United States
San Rafael, California, United States
Westminster, Maryland, United States
South Weymouth, Massachusetts, United States
Norton Shores, Michigan, United States
Creve Coeur, Missouri, United States
Saint Louis, Missouri, United States
Eau Claire, Wisconsin, United States
Milwaukee, Wisconsin, United States
Londonderry, New Hampshire, United States
Sewell, New Jersey, United States
Mukwonago, Wisconsin, United States
Waukesha, Wisconsin, United States
Overland Park, Kansas, United States
Westwood, Kansas, United States
Fairway, Kansas, United States
Coral Gables, Florida, United States
Deerfield Beach, Florida, United States
Perrysburg, Ohio, United States
Willow Grove, Pennsylvania, United States
Brewer, Maine, United States
Seattle, Washington, United States
Fort Worth, Texas, United States
Miami, Florida, United States
Stevens Point, Wisconsin, United States
Springdale, Arkansas, United States
Deer River, Minnesota, United States
Hibbing, Minnesota, United States
Sandstone, Minnesota, United States
Virginia, Minnesota, United States
Ashland, Wisconsin, United States
Medford, Wisconsin, United States
Plantation, Florida, United States
Tampa, Florida, United States
Libertyville, Illinois, United States
Tampa, Florida, United States
Burnsville, Minnesota, United States
Aventura, Florida, United States
Bozeman, Montana, United States
Barrington, Illinois, United States
Crystal Lake, Illinois, United States
Crown Point, Indiana, United States
Dyer, Indiana, United States
Hobart, Indiana, United States
Hobart, Indiana, United States
Indianapolis, Indiana, United States
Munster, Indiana, United States
Valparaiso, Indiana, United States
Oswego, New York, United States
Richardson, Texas, United States
Cudahy, Wisconsin, United States
Newnan, Georgia, United States
Neenah, Wisconsin, United States
New London, Wisconsin, United States
Shawano, Wisconsin, United States
Waupaca, Wisconsin, United States
Lancaster, Pennsylvania, United States
Missoula, Montana, United States
Charleston, South Carolina, United States
Oshkosh, Wisconsin, United States
Springfield, Illinois, United States
Perrysburg, Ohio, United States
Wesley Chapel, Florida, United States
Shiloh, Illinois, United States
Berlin, Wisconsin, United States
Kansas City, Missouri, United States
Avon, Ohio, United States
Des Moines, Iowa, United States
Kalispell, Montana, United States
Dallas, Texas, United States
Lebanon, New Hampshire, United States
Wyoming, Michigan, United States
Grand Rapids, Michigan, United States
Muskegon, Michigan, United States
Nampa, Idaho, United States
Pontiac, Michigan, United States
Foxboro, Massachusetts, United States
Dayton, Ohio, United States
Webster, New York, United States
Danville, Illinois, United States
Greenville, Ohio, United States
Rhinelander, Wisconsin, United States
Stevens Point, Wisconsin, United States
Minocqua, Wisconsin, United States
Osage Beach, Missouri, United States
Verona, New York, United States
Ankeny, Iowa, United States
Marysville, Ohio, United States
Niles, Michigan, United States
Reed City, Michigan, United States
Saint Joseph, Michigan, United States
Des Moines, Iowa, United States
Clive, Iowa, United States
Lansing, Michigan, United States
Grand Rapids, Michigan, United States
Rockford, Illinois, United States
Hays, Kansas, United States
Saint Joseph, Michigan, United States
Pontiac, Michigan, United States
Saint Johnsbury, Vermont, United States
Dayton, Ohio, United States
Sandpoint, Idaho, United States
Ontario, Oregon, United States
Saginaw, Michigan, United States
Tawas City, Michigan, United States
Flint, Michigan, United States
Olathe, Kansas, United States
Mount Vernon, Illinois, United States
Ankeny, Iowa, United States
Clive, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Waukee, Iowa, United States
Cherry Hill, New Jersey, United States
Patients applied
Trial Officials
Megan A Baumgart
Principal Investigator
ECOG-ACRIN Cancer Research Group
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported