Researchers are looking for new ways to treat people with locally advanced non-small cell lung cancer (NSCLC). The goal of this study is to learn if people who receive the combination of vibostolimab and pembrolizumab (MK-7684A) live longer without the cancer getting worse and live longer overall than people who receive durvalumab.
As of protocol amendment 4, participants receiving combination vibostolimab and pembrolizumab (MK-7684A) discontinued treatment due to lack of efficacy observed in other MK-7684A studies, and are given the option to transition to durvalumab therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
610
Administered as an intravenous (IV) infusion
Administered as an IV infusion
Cisplatin 75 mg/m\^2 administered as an IV infusion in combination with pemetrexed on Day 1 of Cycles 1-3 for non-squamous histology only; In combination with etoposide, cisplatin 50 mg/m\^2 is administered on Days 1, 8 of Cycles 1-2 and Days 8, 15 of Cycle 3
Pemetrexed 500 mg/m\^2 administered as an IV infusion on Day 1 of Cycles 1-3 for non-squamous histology only
Etoposide 50 mg/m\^2 is administered as an IV infusion on Days 1-5 of Cycles 1-2 and Days 8-12 of Cycle 3;
Carboplatin area under the curve (AUC) 6 mg/ml/min on Day 1 of Cycle 1 and AUC 2 mg/ml/min on Days 1, 8, 15 of Cycles 2-3, administered as an IV infusion
Paclitaxel 200 mg/m\^2 on Day 1 of Cycle 1 and 45 mg/m\^2 on Days 1, 8, 15 of Cycles 2-3, administered as an IV infusion
60 Gray \[Gy\] in 2 Gy fractions for 30 days total administered as an external beam radiation
VA Long Beach Healthcare System ( Site 2831)
Long Beach, California, United States
VA West Los Angeles Medical Center ( Site 2808)
Los Angeles, California, United States
Millennium Oncology Research Clinic ( Site 2801)
Hollywood, Florida, United States
Mid Florida Hematology and Oncology Center ( Site 2800)
Orange City, Florida, United States
Moffitt Cancer Center ( Site 2818)
Tampa, Florida, United States
Number of Participants Who Experience at Least One 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.
Time frame: Up to approximately 48 months
Number of Participants Who Discontinue Study Treatment Due to 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.
Time frame: Up to approximately 48 months
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University of Chicago Medical Center ( Site 2828)
Chicago, Illinois, United States
Franciscan St. Francis Health ( Site 2812)
Indianapolis, Indiana, United States
MFSMC-HJWCI ( Site 2804)
Baltimore, Maryland, United States
Boston Medical Center ( Site 2829)
Boston, Massachusetts, United States
University of Massachusetts Chan Medical School ( Site 2815)
Worcester, Massachusetts, United States
...and 150 more locations