A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)
Status: Recruiting
Location: See all (19) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Researchers want to learn if the study medicines MK-1084 and subcutaneous (SC) pembrolizumab can be used to treat non-small cell lung cancer (NSCLC) when given together. MK-1084 is a targeted therapy for the KRAS G12C mutation. The goal of this study is to learn if people who receive MK-1084 with SC pembrolizumab live longer without the cancer growing or spreading than in people who receive SC pembrolizumab with chemotherapy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ The main inclusion criteria include but are not limited to the following:
• Has nonsquamous NSCLC (Stage IIIB, Stage IIIC) not eligible for curative resection or chemoradiation or Stage IV: M1a, M1b, or M1c
• If human immunodeficiency virus (HIV) positive, must have well controlled HIV on antiretroviral therapy (ART)
Locations
United States
Connecticut
Stamford Hospital ( Site 0126)
RECRUITING
Stamford
Florida
Mount Sinai Cancer Center ( Site 0137)
RECRUITING
Miami Beach
Maine
New England Cancer Specialists ( Site 0139)
RECRUITING
Westbrook
New York
New York Oncology Hematology, P.C. ( Site 0119)
RECRUITING
Albany
Other Locations
Australia
Mater Hospital Brisbane ( Site 2906)
RECRUITING
South Brisbane
Israel
Shaare Zedek Medical Center ( Site 1706)
RECRUITING
Jerusalem
Meir Medical Center. ( Site 1702)
RECRUITING
Kfar Saba
Sourasky Medical Center ( Site 1705)
RECRUITING
Tel Aviv
Japan
Osaka Metropolitan University Hospital ( Site 2826)
RECRUITING
Osaka
National Hospital Organization Ureshino Medical Center ( Site 2817)
RECRUITING
Ureshino
Republic of Korea
Chonnam National University Hwasun Hospital ( Site 3502)
RECRUITING
Jeollanam-do
Korea University Guro Hospital ( Site 3505)
RECRUITING
Seoul
Taiwan
Chang Gung Memorial Hospital- Chiayi ( Site 3611)
RECRUITING
Chiayi City
National Cheng Kung University Hospital ( Site 3604)
RECRUITING
Tainan
Ukraine
Municipal Enterprise Bukovinian сlinical oncology сenter ( Site 2504)
RECRUITING
Chernivtsi
Shalimov Institute of Surgery and Transplantation Oncology department ( Site 2512)
RECRUITING
Kyiv
Universal Clinic Oberig ( Site 2506)
RECRUITING
Kyiv
Communal noncommercial enterprise of Lviv regional council Lviv oncological regional therapeutical ( Site 2507)
RECRUITING
Lviv
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2517)
RECRUITING
Rivne
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2025-10-08
Estimated Completion Date: 2032-08-06
Participants
Target number of participants: 675
Treatments
Experimental: MK-1084 + Pembrolizumab (+) Berahyaluronidase alfa
Participants will receive pembrolizumab (+) berahyaluronidase alfa at a fixed dose subcutaneously on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) plus MK-1084 until discontinuation criterion is met.
Active_comparator: Pembrolizumab (+) Berahyaluronidase alfa + Chemotherapy
Participants will receive pembrolizumab (+) berahyaluronidase alfa at a fixed dose subcutaneously on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) and pemetrexed via intravenous (IV) infusion at a dose of 500 mg/m\^2 on days 1 and 22 of cycles 1 and 3 until discontinuation criterion is met PLUS investigator's choice of carboplatin via IV infusion at area under curve (AUC) 5 mg/mL/minute on days 1 and 22 of cycles 1 and 3 (up to 4 doses, approximately 6 weeks) OR cisplatin via IV infusion at a dose of 75 mg/m\^2 on days 1 and 22 of cycles 1 and 3 (up to 4 doses, approximately 6 weeks).
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC