MK-7684 with Pembrolizumab as a Coformulation (MK-7684A) Versus Pembrolizumab Monotherapy for PD-L1 Positive Metastatic NSCLC

JRCT ID: jRCT2021210025

Registered date:11/08/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Untreated PD-L1 Positive Metastatic Non-Small Cell Lung Cancer
• Date of first enrollment: 11/08/2021
• Target sample size: 598
• Countries of recruitment: USA,Japan,Canada,Japan,Russia,Japan,Ukraine,Japan,Turkey,Japan,Hungary,Japan,South Africa,Japan,Mexico,Japan,Brazil,Japan,Chile,Japan,Guatemala,Japan,Peru,Japan,Hong Kong,Japan,South Korea,Japan,Malaysia,Japan,Thailand,Japan,Taiwan,Japan,China,Japan
• Study type: Interventional
• Intervention(s): MK-7684A (coformulation of Vibostolimab 200mg and pembrolizumab 200mg) will be administered using a 30 minute IV infusion every 3 weeks.

Outcome(s)

Primary Outcome

-PFS per RECIST 1.1 as assessed by BICR
-OS

Secondary Outcome

-ORR per RECIST 1.1 as assessed by BICR
-DOR per RECIST 1.1 as assessed by BICR
-Mean change from baseline (at randomization) in global health status/quality of life (QoL), physical functioning, dyspnea, cough, and chest pain
-TTD in global health status/QoL, physical functioning, dyspnea, cough, and chest pain
-Safety and tolerability

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Has a histologically or cytologically confirmed diagnosis of Stage IV: M1a, M1b, or M1c non-small cell lung cancer (NSCLC) per the American Joint Committee on Cancer (AJCC) Staging Manual, version 8
-Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as determined by the local site assessment
-Has confirmation that epidermal growth factor receptor (EGFR)-, anaplastic lymphoma kinase (ALK)-, or reactive oxygen species proto-oncogene 1 (ROS1)-directed therapy is not indicated as primary therapy and absence of ALK and ROS1 gene rearrangements
-Has provided tumor tissue that demonstrates Programmed Cell Death 1 Ligand 1 (PD-L1) expression in >=1% of tumor cells as assessed by immunohistochemistry (IHC) at a central laboratory
-Has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 assessed within 7 days prior to randomization
-Has a life expectancy of at least 3 months
-A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
-Is not a woman of childbearing potential (WOCBP)
-Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 120 days after the last dose of study intervention
-Has adequate organ function

Exclude criteria

-Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for at least 3 years since initiation of that therapy
-Has received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC.
Note:Prior treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 6 months before the diagnosis of metastatic NSCLC.
Note:Participants must have recovered from all AEs due to previous therapies to less than or equal to Grade 1 or baseline. Participants with less than or equal to Grade 2 neuropathy may be eligible. Participants with endocrine-related AEs less than or equal to Grade 2 requiring treatment or hormone replacement may be eligible.
-Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137)
-Has received previous treatment with another agent targeting the T cell immunoreceptor with immunoglobulin (Ig) and immunoreceptor tyrosine-based inhibition motif (ITIM) domains (TIGIT) receptor pathway
-Has received radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=<2 weeks of radiotherapy) to non-central nervous system (CNS) disease
-Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Administration of killed vaccines is allowed

Related Information

• Primary Sponsor: Nohata Nijiro
• Secondary ID(s): NCT04738487