This phase III trial compares standard therapy given after surgery (adjuvant) to standard therapy given before surgery (neoadjuvant) and after surgery in treating patients with stage II-IIIB non-small cell lung cancer (NSCLC) that can be removed by surgery (resectable). The usual approach for patients with resectable NSCLC is chemotherapy and/or immunotherapy before surgery, after surgery, or both before and after surgery. This study is being done to find out which approach is better at treating patients with lung cancer. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Other chemotherapy drugs, such as vinorelbine, 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. Immunotherapy with monoclonal antibodies, such as nivolumab, pembrolizumab, and atezolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with chemotherapy and immunotherapy prior to surgery and continuing treatment after surgery may be a more effective treatment option than adjuvant therapy alone in patients with stage II-IIIB resectable NSCLC.
Additional locations may be listed on ClinicalTrials.gov for NCT06632327 .
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Contact: Site Public Contact
Phone: 315-464-5476
State University of New York Upstate Medical University Status: Active
Contact: Site Public Contact
Phone: 315-464-5476
Verona Upstate Cancer Center at Verona Status: Active
Contact: Site Public Contact
Phone: 315-464-8230
Webster Wilmot Cancer Institute at Webster Status: Active
Contact: Site Public Contact
North Dakota Bismarck Sanford Bismarck Medical Center Status: Active
Contact: Site Public Contact
Phone: 701-323-5760
Fargo Sanford Roger Maris Cancer Center Status: Active
Contact: Site Public Contact
Phone: 701-234-6161
Sanford Broadway Medical Center Status: Active
Contact: Site Public Contact
Phone: 701-323-5760
Southpointe-Sanford Medical Center Fargo Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Sanford South University Medical Center Status: Active
Contact: Site Public Contact
Phone: 701-234-6161
Sanford Medical Center Fargo Status: Active
Contact: Site Public Contact
Phone: 800-437-4010
Ohio Cincinnati TriHealth Cancer Institute-Anderson Status: Active
Contact: Site Public Contact
Phone: 720-874-1881
TriHealth Cancer Institute-Westside Status: Active
Contact: Site Public Contact
Phone: 720-874-1881
Bethesda North Hospital Status: Active
Contact: Site Public Contact
Phone: 720-874-1881
Good Samaritan Hospital - Cincinnati Status: Active
Contact: Site Public Contact
Phone: 720-874-1881
Oklahoma Lawton Cancer Centers of Southwest Oklahoma Research Status: Active
Contact: Site Public Contact
Phone: 877-231-4440
Oklahoma City University of Oklahoma Health Sciences Center Status: Active
Contact: Site Public Contact
Phone: 405-271-8777
Mercy Hospital Oklahoma City Status: Active
Contact: Site Public Contact
Phone: 405-752-3402
Oregon Baker City Saint Alphonsus Cancer Care Center-Baker City Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Gresham Legacy Mount Hood Medical Center Status: Active
Contact: Site Public Contact
Phone: 503-413-2150
Ontario Saint Alphonsus Cancer Care Center-Ontario Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Portland Legacy Good Samaritan Hospital and Medical Center Status: Active
Contact: Site Public Contact
Phone: 800-220-4937
Tualatin Legacy Meridian Park Hospital Status: Active
Contact: Site Public Contact
Phone: 503-413-1742
Pennsylvania Chadds Ford Christiana Care Health System-Concord Health Center Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Danville Geisinger Medical Center Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Dickson City Geisinger Cancer Center Dickson City Status: Active
Contact: Site Public Contact
Phone: 877-204-6081
Hazleton Geisinger Medical Center-Cancer Center Hazleton Status: Active
Contact: Site Public Contact
Phone: 570-459-2901
Lewisburg Geisinger Medical Oncology-Lewisburg Status: Active
Contact: Site Public Contact
Phone: 570-374-8555
Wilkes-Barre Geisinger Wyoming Valley/Henry Cancer Center Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
South Carolina Charleston Medical University of South Carolina Status: Active
Contact: Site Public Contact
Phone: 843-792-9321
Florence McLeod Regional Medical Center Status: Active
Contact: Site Public Contact
Phone: 843-777-0770
Gaffney Gibbs Cancer Center-Gaffney Status: Active
Contact: Site Public Contact
Phone: 864-560-6104
Greenwood Self Regional Healthcare Status: Active
Contact: Site Public Contact
Phone: 864-725-4771
Greer Gibbs Cancer Center-Pelham Status: Active
Contact: Site Public Contact
Phone: 864-560-6104
Spartanburg Spartanburg Medical Center Status: Active
Contact: Site Public Contact
Phone: 864-560-6104
North Grove Medical Park Status: Active
Contact: Site Public Contact
Phone: 864-560-6812
Spartanburg Medical Center - Mary Black Campus Status: Active
Contact: Site Public Contact
Phone: 864-560-6812
Union SMC Center for Hematology Oncology Union Status: Active
Contact: Site Public Contact
Phone: 864-560-6104
South Dakota Sioux Falls Sanford USD Medical Center - Sioux Falls Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Sanford Cancer Center Oncology Clinic Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Tennessee Collierville Baptist Memorial Hospital and Cancer Center-Collierville Status: Active
Contact: Site Public Contact
Phone: 901-226-1366
Memphis Baptist Memorial Hospital and Cancer Center-Memphis Status: Active
Contact: Site Public Contact
Phone: 901-226-1366
Texas Houston Lyndon Baines Johnson General Hospital Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 713-566-5000
Virginia Charlottesville University of Virginia Cancer Center Status: Active
Contact: Site Public Contact
Phone: 434-243-6303
Washington Silverdale Saint Michael Cancer Center Status: Active
Contact: Site Public Contact
Phone: 720-874-1881
Vancouver Legacy Cancer Institute Medical Oncology and Day Treatment Status: Active
Contact: Site Public Contact
Legacy Salmon Creek Hospital Status: Active
Contact: Site Public Contact
Phone: 503-413-2150
Wisconsin Antigo Langlade Hospital and Cancer Center Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 715-623-9869
Appleton ThedaCare Regional Cancer Center Status: Active
Contact: Site Public Contact
Phone: 920-364-3604
Berlin ThedaCare Cancer Care - Berlin Status: Active
Contact: Site Public Contact
Phone: 920-364-3605
Chippewa Falls Marshfield Clinic-Chippewa Center Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Eau Claire Marshfield Medical Center-EC Cancer Center Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Green Bay Saint Vincent Hospital Cancer Center at Saint Mary's Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Saint Vincent Hospital Cancer Center Green Bay Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
La Crosse Gundersen Lutheran Medical Center Status: Active
Contact: Site Public Contact
Phone: 608-775-2385
Ladysmith Marshfield Medical Center - Ladysmith Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Marshfield Marshfield Medical Center-Marshfield Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Medford Aspirus Medford Hospital Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 715-847-2353
Milwaukee Medical College of Wisconsin Status: Active
Contact: Site Public Contact
Phone: 414-805-3666
Zablocki Veterans Administration Medical Center Status: Active
Contact: Site Public Contact
Phone: 888-469-6614
Minocqua Marshfield Medical Center - Minocqua Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Mukwonago ProHealth D N Greenwald Center Status: Active
Contact: Site Public Contact
Neenah ThedaCare Regional Medical Center - Neenah Status: Active
Contact: Site Public Contact
Phone: 920-364-3605
Neillsville Marshfield Medical Center - Neillsville Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
New London ThedaCare Cancer Care - New London Status: Active
Contact: Site Public Contact
Phone: 920-364-3605
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
Oconto Falls Saint Vincent Hospital Cancer Center at Oconto Falls Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Oshkosh ThedaCare Cancer Care - Oshkosh Status: Active
Contact: Site Public Contact
Phone: 920-364-3605
Rhinelander Aspirus Cancer Care - James Beck Cancer Center Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 715-847-2353
Rice Lake Marshfield Medical Center-Rice Lake Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Shawano ThedaCare Cancer Care - Shawano Status: Active
Contact: Site Public Contact
Phone: 920-364-3605
Sheboygan Saint Vincent Hospital Cancer Center at Sheboygan Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Sheboygan Physicians Group Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Stevens Point Aspirus Cancer Care - Stevens Point Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 715-847-2353
Marshfield Medical Center-River Region at Stevens Point Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Sturgeon Bay Saint Vincent Hospital Cancer Center at Sturgeon Bay Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Waukesha UW Cancer Center at ProHealth Care Status: Active
Contact: Site Public Contact
Phone: 262-928-5539
ProHealth Waukesha Memorial Hospital Status: Active
Contact: Site Public Contact
Phone: 262-928-7632
Waupaca ThedaCare Cancer Care - Waupaca Status: Active
Contact: Site Public Contact
Phone: 920-364-3605
Wausau Marshfield Clinic-Wausau Center Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Aspirus Regional Cancer Center Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 877-405-6866
Weston Marshfield Medical Center - Weston Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Wisconsin Rapids Marshfield Clinic - Wisconsin Rapids Center Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Aspirus Cancer Care - Wisconsin Rapids Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 715-422-7718
Wyoming Cody Billings Clinic-Cody Status: Active
Contact: Site Public Contact
Phone: 800-996-2663
PRIMARY OBJECTIVE:
I. To compare the 3-year real-world event-free survival (rwEFS) rate and overall survival (OS) between perioperative and adjuvant immunotherapy-based treatment for patients with resectable non-small cell lung cancer (dual endpoints).
SECONDARY OBJECTIVES:
I. To compare the rates of surgical resection between the two arms.
II. To compare the rates of complete resection (R0) between the two arms.
III. To summarize and compare rates of adverse events (AEs) resulting in permanent treatment discontinuation, hospitalization, or death between the two arms.
IV. To evaluate the association between locally defined pathological complete response (pCR) and rwEFS in patients randomized to the perioperative arm (arm 2).
V. To compare the rwEFS post 3-years from randomization between the two arms among patients who do not experience an event by 3 years.
EXPLORATORY OBJECTIVES:
I. To compare rwEFS and OS between the patients who are randomized to the adjuvant arm (arm 1) and perioperative arm (arm 2), who were compliant with the recommended treatment per arm defined as at least 3 cycles of systemic therapy.
II. To compare the sites of relapse between the two treatment arms.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1:
SURGERY: Patients undergo surgery within 28 days of registration.
ADJUVANT THERAPY: Patients receive platinum-based doublet chemotherapy (cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, and/or vinorelbine) for up to 4 cycles and immune checkpoint inhibitor therapy (nivolumab, pembrolizumab, and/or atezolizumab) for up to 1 year in the absence of disease progression or unacceptable toxicity according to current approved guidelines.
ARM 2:
NEOADJUVANT THERAPY: Within 28 days of registration, patients receive platinum-based doublet chemotherapy (cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, and/or vinorelbine) for up to 4 cycles in combination with immune checkpoint inhibitor (nivolumab, pembrolizumab, and/or atezolizumab) according to current approved guidelines.
SURGERY: Patients undergo surgery.
ADJUVANT THERAPY: Patients receive immune checkpoint inhibitor therapy (nivolumab, pembrolizumab, and/or atezolizumab) for up to 1 year in the absence of disease progression or unacceptable toxicity according to current approved guidelines.
Patients also undergo computed tomography (CT) throughout the study and may undergo magnetic resonance imaging (MRI) and/or positron emission tomography (PET)/CT at screening.
After completion of study treatment, patients are followed up every 6 months for 3 years, then annually for years 4-10.
Lead Organization Alliance for Clinical Trials in Oncology
Principal Investigator Daniel Morgensztern