Treatment for Advanced Non-small Cell Lung Cancer With Actionable Genomic Alterations After Targeted Treatment and Chemotherapy (An Expanded Lung-MAP Treatment Trial)
Start Date
9/22/2026
Completion Date
11/1/2029
Summary
This phase II Expanded Lung-MAP treatment trial compares how well sacituzumab govitecan alone, ivonescimab alone, or sacituzumab govitecan in combination with ivonescimab works in treating patients with non-small cell lung cancer (NSCLC) that has come back after a period of improvement (recurrent) or is stage IV and has a change in at least 1 of these genes: ALK, EGFR, HER2 (ERBB2), MET, NTRK, RET, and ROS1. This type of gene change is called an actionable genomic alteration (AGA), which means certain treatments can target the change to fight the cancer. Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a toxic drug called SN-38. Sacituzumab govitecan is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as TROP2 receptors, and delivers SN-38 to kill them. Ivonescimab is a bispecific antibody that can bind to two different antigens at the same time. It binds to programmed cell death protein 1 (PD1), a protein found on the surface of T cells (a type of white blood cell) and vascular endothelial growth factor (VEGF), a protein found on the surface of tumor cells. Ivonescimab may strengthen the immune system and interfere with the ability of tumor cells to grow and spread. Giving a combination of sacituzumab govitecan and ivonescimab work better than either drug alone, and sacituzumab govitecan alone, ivonescimab alone, or sacituzumab govitecan and ivonescimab together may work better than standard treatments at shrinking NSCLC with an AGA.
Detailed Description
PRIMARY OBJECTIVES: I. To compare progression-free survival (PFS) between participants randomized to the combination of sacituzumab govitecan plus ivonescimab (SG-I) and sacituzumab govitecan (SG) alone. (Comparison between arms) II. To compare progression-free survival (PFS) between participants randomized to SG-I and ivonescimab (I) alone. (Comparison between arms) III. To evaluate the response (confirmed and unconfirmed, complete and partial) rate of SG against historical response rates. (Single Arm evaluation) IV. To evaluate the response (confirmed and unconfirmed, complete and partial) rate of I against historical response rates. (Single Arm evaluation) V. To evaluate the response (confirmed and unconfirmed, complete and partial) rate of SG-I against historical response rates. (Single Arm evaluation) SECONDARY OBJECTIVES: I. To evaluate the rate of dose-limiting toxicities among participants treated with SG-I in the safety run-in analysis population. II. To compare response rates between ivonescimab with or without sacituzumab govitecan. III. To compare response rates of sacituzumab govitecan with or without ivonescimab. IV. To compare overall survival between the SG-I and SG arms. V. To compare overall survival between the SG-I and I arms. VI. To summarize disease control rates within each treatment arm. VII. To summarize the duration of response (DoR) among responders within each treatment arm. VIII. To evaluate the central nervous system (CNS) progression-free survival per local investigator assessment in participants with baseline CNS metastasis within each treatment arm. VIII. To evaluate the frequency and severity of toxicities within each treatment arm. IX. To evaluate if clinical outcomes (response, progression-free survival \[PFS\], overall survival \[OS\]) within each treatment arm differs between the subgroup of participants with EGFR mutations to those without EGFR mutations. X. To evaluate if clinical outcomes (response, PFS, OS) within each treatment arm differs between the subgroup of participants by the presence or absence of PD-L1 expression (\< 1% vs 1% or greater). TRANSLATIONAL MEDICINE OBJECTIVES: I. To perform comprehensive next-generation sequencing of circulating tumor deoxyribonucleic acid (DNA) (ctDNA) at baseline in all participants to assess its clinical utility in comparison to tumor tissue biomarker profiles. II. To process and bank cell free DNA (cfDNA) at cycle 3 day 1 and progression for future development of a proposal to evaluate comprehensive next-generation sequencing of circulating tumor DNA (ctDNA). III. To establish a tissue/blood repository to pursue future studies. OUTLINE: Patients are randomized to 1 of 3 arms. ARM 1: Patients receive ivonescimab intravenously (IV) over 1-2 hours on day 1 of each cycle and sacituzumab govitecan IV over 1-3 hours on day 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) and blood sample collection throughout the study. ARM 2: Patients receive sacituzumab govitecan IV over 1-3 hours on day 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and blood sample collection throughout the study. ARM 3: Patients receive ivonescimab IV over 1-2 hours on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and blood sample collection throughout the study. After completion of study treatment, patients without disease progression are followed every 12 weeks or more often as clinically indicated until progression, then every 6 months for 2 years and then at end of 3 years from date of randomization. Patients with disease progression are followed every 6 months for 2 years and then at end of 3 years from date of randomization.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Biospecimen Collection
Computed Tomography
Ivonescimab
Magnetic Resonance Imaging
Sacituzumab Govitecan
Conditions
Locations
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California 94704
United States
Palo Alto Medical Foundation Health Care
Palo Alto, California 94301
United States
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia 30501
United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho 83864
United States
Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
United States
Illinois CancerCare-Canton
Canton, Illinois 61520
United States
Illinois CancerCare-Carthage
Carthage, Illinois 62321
United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
United States
Decatur Memorial Hospital
Decatur, Illinois 62526
United States
Illinois CancerCare-Eureka
Eureka, Illinois 61530
United States
Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
United States
Illinois CancerCare-Macomb
Macomb, Illinois 61455
United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
United States
Illinois CancerCare-Pekin
Pekin, Illinois 61554
United States
Illinois CancerCare-Peoria
Peoria, Illinois 61615
United States
Illinois CancerCare-Peru
Peru, Illinois 61354
United States
Illinois CancerCare-Princeton
Princeton, Illinois 61356
United States
Southern Illinois University School of Medicine
Springfield, Illinois 62702
United States
Springfield Clinic
Springfield, Illinois 62702
United States
Springfield Memorial Hospital
Springfield, Illinois 62781
United States
Illinois CancerCare - Washington
Washington, Illinois 61571
United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan 48912
United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan 48341
United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
United States
Saint Francis Medical Center
Cape Girardeau, Missouri 63703
United States
Billings Clinic Cancer Center
Billings, Montana 59101
United States
Community Medical Center
Missoula, Montana 59804
United States
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire 03301
United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire 03756
United States
Solinsky Center for Cancer Care
Manchester, New Hampshire 03103
United States
ProMedica Flower Hospital
Sylvania, Ohio 43560
United States
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont 05819
United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin 54601
United States