The purpose of this study is to assess the safety and efficacy of pemetrexed+platinum chemotherapy+pembrolizumab (MK-3475) with or without lenvatinib (MK-7902/E7080) as first-line intervention in adults from mainland China with metastatic nonsquamous non-small cell lung cancer. The primary study hypotheses state that: 1) the combination of lenvatinib+platinum doublet chemotherapy+pembrolizumab prolongs Progression-free Survival (PFS) as assessed by blinded independent central review (BICR) per modified Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST 1.1) compared to matching placebo+platinum doublet chemotherapy+pembrolizumab, and 2) the combination of lenvatinib+platinum doublet chemotherapy+pembrolizumab prolongs Overall Survival (OS) compared to matching placebo+platinum doublet chemotherapy + pembrolizumab.
The China extension study will include participants previously enrolled in mainland China for the global study for MK-7902-006 (NCT03829319) plus those enrolled in mainland China as part of the China extension enrollment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
201
IV infusion Q3W
IV infusion Q3W
IV infusion Q3W
IV infusion Q3W
Oral capsule once daily
Oral capsule once daily
Peking Union Medical College Hospital ( Site 0108)
Beijing, Beijing Municipality, China
Cancer Hospital Chinese Academy of Medical Science ( Site 0117)
Beijing, Beijing Municipality, China
Beijing Cancer Hospital ( Site 0120)
Beijing, Beijing Municipality, China
The Second Hospital Affiliated to AMU ( Site 0119)
Chongqing, Chongqing Municipality, China
First Affiliated Hospital of The Third Military Medical University ( Site 0118)
Chongqing, Chongqing Municipality, China
Fujian Provincial Cancer Hospital ( Site 0102)
Fuzhou, Fujian, China
Southern Medical University Nanfang Hospital ( Site 0121)
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Harbin Medical University ( Site 0100)
Harbin, Heilongjiang, China
Henan Cancer Hospital ( Site 0112)
Zhengzhou, Henan, China
Wuhan Union Hospital ( Site 0123)
Wuhan, Hubei, China
...and 9 more locations
Part 2: Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
PFS is defined as the time from date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurred first. Per 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. Note: The appearance of one or more new lesions was also considered PD. Data are from the product-limit (Kaplan-Meier) method for censored data. PFS as assessed by blinded independent central review (BICR) per RECIST 1.1 is presented.
Time frame: Up to approximately 43 months
Part 2: Overall Survival (OS)
OS is defined as the time from randomization to the time of death from any cause. OS is presented.
Time frame: Up to approximately 43 months
Part 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
ORR is defined as the percentage of participants in the analysis population who have a 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 RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. ORR as assessed per modified RECIST 1.1 will be presented.
Time frame: Up to approximately 57 months
Part 2: Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
For participants who demonstrated CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), DOR is defined as the time from the first documented evidence of CR or PR until PD or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, or death from any cause, 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. Note: The appearance of one or more new lesions is also considered PD. DOR as assessed per modified RECIST 1.1 will be presented.
Time frame: Up to approximately 57 months
Part 2: Number of Participants Who Experienced an Adverse Event (AE)
An adverse event is defined as 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 experienced one of more adverse events during Part 2 of this study were presented.
Time frame: Up to approximately 42 months
Part 2: Number of Participants Who Discontinued Study Drug Due to an Adverse Event
An adverse event is defined as 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 discontinued study treatment during Part 2 of this study were presented.
Time frame: Up to approximately 42 months
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