The purpose of this study is to evaluate the use of investigational agents (MK-4830, boserolimab (MK-5890) and lenvatinib (MK-7902)) in combination with pembrolizumab (MK-3475) and etoposide/platinum chemotherapy for the first-line treatment of participants with extensive-stage small cell Lung Cancer (ES-SCLC). No formal hypothesis testing will be performed for this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
122
IV infusion
IV infusion
IV infusion
Oral capsule
IV infusion
IV infusion
IV infusion
Banner MD Anderson Cancer Center ( Site 0102)
Gilbert, Arizona, United States
University of Colorado Anschutz Medical Campus ( Site 0104)
Aurora, Colorado, United States
Georgia Cancer Specialists ( Site 0106)
Atlanta, Georgia, United States
Parkview Research Center at Parkview Regional Medical Center ( Site 0130)
Fort Wayne, Indiana, United States
Baptist Health Lexington-Research ( Site 0108)
Lexington, Kentucky, United States
Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
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) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR is presented.
Time frame: Up to approximately 43 months
Six-Month Progression-Free Survival (PFS) Rate as Assessed by BICR Per RECIST 1.1
Six-month PFS rate is defined as the percentage of participants who have survival without documented progressive disease (PD) per RECIST 1.1 by BICR or death due to any cause, whichever occurs first at 6 months after randomization. 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 rate at 6 months as assessed by BICR is presented.
Time frame: At 6 months
Duration of Response (DOR) as Assessed by BICR Per RECIST 1.1
For participants who demonstrated a confirmed 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) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on blinded central imaging review with confirmation. The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR is presented.
Time frame: Up to approximately 43 months
Progression-Free Survival (PFS) as Assessed by BICR Per RECIST 1.1
PFS is defined as the time from randomization to the first documented PD per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. 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 is presented.
Time frame: Up to approximately 43 months
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. The OS for all participants is presented.
Time frame: Up to approximately 43 months
Mean Percent Change From Baseline in Tumor Size as Assessed by BICR Per RECIST 1.1
Tumor size change is defined as the best percent change from baseline in the sum of the diameters of the target lesions as assessed by BICR per RECIST 1.1. The mean best percent change from baseline in tumor size as assessed by BICR per RECIST 1.1 is presented.
Time frame: Baseline and up to 43 months
Number of Participants Who Experienced an Adverse Event (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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE is presented.
Time frame: Up to approximately 43 months
Number of Participants Who Discontinued Study Treatment 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study treatment due to an AE is presented.
Time frame: Up to approximately 22 months
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized so that the total score ranges from 0 to 100 for the combined scores. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score is presented.
Time frame: Baseline, Week 19
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MFSMC-HJWCI-Oncology Research ( Site 0128)
Baltimore, Maryland, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0122)
Omaha, Nebraska, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0129)
Omaha, Nebraska, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0114)
Mineola, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 0115)
New York, New York, United States
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