KEYMAKER-U01 Substudy 01H: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC)
Summary
Researchers are looking for new ways to treat metastatic nonsquamous non-small cell lung cancer (NSCLC) that has been treated before. Metastatic means the cancer has spread to other parts of the body. Nonsquamous means the cancer did not start in squamous cells, which are flat cells that line the inside of the lungs. Standard treatment (usual treatment) for NSCLC is surgery, then immunotherapy with or without chemotherapy after surgery. Immunotherapy is a treatment that helps the immune system fight cancer. Chemotherapy is a medicine that works to destroy cancer cells or stop them from growing. However, standard treatment may not work or may stop working for some people. Researchers want to know if 2 antibody drug conjugates (ADCs) can help treat metastatic nonsquamous NSCLC that did not respond (get smaller or go away) to treatment. An ADC attaches to specific targets on cancers cells and delivers treatment to destroy those cells. Researchers will compare 2 different ADCs (the study treatments) to chemotherapy in this study. The goals of this study are to learn: * About the safety of the study treatments and if people tolerate them * How many people have the cancer respond to the study treatments
Detailed description
The master screening protocol is MK-3475-U01 (KEYMAKER-U01) - NCT04165798
Arms & interventions
- BiologicalRaludotatug Deruxtecan
IV Infusion
- BiologicalIfinatamab Deruxtecan
IV Infusion
- DrugDocetetaxel
IV Infusion
- Drug5-hydroxytryptamine subtype 3 receptor antagonist
Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion
- DrugNeurokinin-1 receptor antagonist
Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion
- DrugCorticosteroid
Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion, and for 3 days starting 1 day prior to docetaxel administration
Outcome measures
Primary
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Time frame: Up to approximately 81 months
Percentage of Participants with at Least One Adverse Event (AE)
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The percentage of participants who experience an AE will be reported.
Time frame: Up to approximately 81 months
Percentage of Participants Who Discontinued Medication Due to an AE
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The percentage of participants who discontinue study intervention due to an AE will be reported.
Time frame: Up to approximately 24 months
Secondary
Duration of Response (DOR)
Time frame: Up to approximately 81 months
Progression-free Survival (PFS)
Time frame: Up to approximately 81 months
Overall Survival (OS)
Time frame: Up to approximately 81 months
Eligibility criteria
Study locations (2)
University of Kentucky Chandler Medical Center ( Site 0019)
Lexington, Kentucky, 40536-0293
MedStar Franklin Square Medical Center ( Site 0033)
Baltimore, Maryland, 21237