Researchers are looking for other ways to treat metastatic squamous non-small cell lung cancer (NSCLC). Squamous NSCLC is cancer that starts in squamous cells, which are flat cells that line the inside of the airways in the lungs. Metastatic means the cancer has spread to other parts of the body. Standard treatment (usual treatment) for metastatic squamous NSCLC is immunotherapy with or without chemotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. Chemotherapy is medicine that destroys cancer cells or stops them from growing. However, standard treatment may not work or may stop working to treat metastatic squamous NSCLC. Researchers want to learn if study treatments that are antibody drug conjugates (ADCs) can treat metastatic squamous NSCLC that did not respond (get smaller or go away) to standard treatment. An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The main goals of this study are to learn about: * The cancer response to the study treatments compared to chemotherapy * The safety of the study treatments and if people tolerate them This study is one of the substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).
The master screening protocol is MK-3475-U01 (KEYMAKER-U01) - NCT04165798
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
144
University of Kentucky Chandler Medical Center ( Site 0019)
Lexington, Kentucky, United States
RECRUITINGMedStar Franklin Square Medical Center ( Site 0033)
Baltimore, Maryland, United States
RECRUITINGCentro de Estudios Clínicos SAGA ( Site 0161)
Santiago, Region M. de Santiago, Chile
RECRUITINGFALP ( Site 0160)
Santiago, Region M. de Santiago, Chile
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) as assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). ORR will be assessed by Blinded Independent Central Review (BICR). The percentage of participants who experience CR or PR as assessed by the investigator will be presented.
Time frame: Up to approximately 81 months
Number of participants who experience one or more adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Time frame: Up to approximately 81 months
Number of participants who discontinue study intervention due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Time frame: Up to approximately 81 months
Duration of Response (DOR)
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Time frame: Up to approximately 81 months
Progression-free Survival (PFS)
PFS is defined as the time from randomization to the first documented PD or death due to any cause, whichever occurs first as assessed by (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.
Time frame: Up to approximately 81 months
Overall Survival (OS)
OS is defined as time from randomization to death due to any cause.
Time frame: Up to approximately 81 months
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Bradfordhill ( Site 0162)
Santiago, Region M. de Santiago, Chile
RECRUITINGChongqing University Cancer Hospital ( Site 0304)
Chongqing, Chongqing Municipality, China
RECRUITINGFujian Provincial Cancer Hospital ( Site 0310)
Fuzhou, Fujian, China
RECRUITINGGuangxi Medical University Cancer Hospital ( Site 0303)
Nanning, Guangxi, China
RECRUITINGHenan Cancer Hospital ( Site 0311)
Zhengzhou, Henan, China
RECRUITINGNanjing Drum Tower Hospital JiangBei International Branch Hospital ( Site 0309)
Nanjing, Jiangsu, China
RECRUITING...and 27 more locations