A Clinical Study of MK-1084 and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)
NCT ID: NCT07190248
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
675 participants
INTERVENTIONAL
2025-10-08
2032-08-06
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
MK-1084
Administered as an oral tablet
Pembrolizumab (+) Berahyaluronidase alfa
Administered as a SC injection
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).
Pembrolizumab (+) Berahyaluronidase alfa
Administered as a SC injection
Pemetrexed
Administered as an IV Infusion
Cisplatin
Administered as an IV Infusion
Carboplatin
Administered as an IV Infusion
Interventions
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MK-1084
Administered as an oral tablet
Pembrolizumab (+) Berahyaluronidase alfa
Administered as a SC injection
Pemetrexed
Administered as an IV Infusion
Cisplatin
Administered as an IV Infusion
Carboplatin
Administered as an IV Infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* If human immunodeficiency virus (HIV) positive, must have well controlled HIV on antiretroviral therapy (ART)
Exclusion Criteria
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea)
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
* Has a gastrointestinal disorder affecting absorption
* Is HIV positive and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Has received prior systemic anticancer therapy for their advanced or metastatic NSCLC
* Has known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has active autoimmune disease that has required systemic treatment in the past 2 years
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has active infection requiring systemic therapy except those specified by protocol
* Has history of stem cell/solid organ transplant
* Has not adequately recovered from major surgery or has ongoing surgical complications
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Central Alabama Research ( Site 0108)
Birmingham, Alabama, United States
Stamford Hospital ( Site 0126)
Stamford, Connecticut, United States
Mount Sinai Cancer Center ( Site 0137)
Miami Beach, Florida, United States
New England Cancer Specialists ( Site 0139)
Westbrook, Maine, United States
New York Oncology Hematology, P.C. ( Site 0119)
Albany, New York, United States
Mater Hospital Brisbane ( Site 2906)
South Brisbane, Queensland, Australia
Reformatus Pulmonologiai Centrum ( Site 1503)
Törökbálint, Pest County, Hungary
Yitzhak Shamir Medical Center. ( Site 1709)
Beer Ya Akov, , Israel
Shaare Zedek Medical Center ( Site 1706)
Jerusalem, , Israel
Meir Medical Center. ( Site 1702)
Kfar Saba, , Israel
Sourasky Medical Center ( Site 1705)
Tel Aviv, , Israel
National Hospital Organization Ureshino Medical Center ( Site 2817)
Ureshino, Saga-ken, Japan
Osaka Metropolitan University Hospital ( Site 2826)
Osaka, , Japan
Institutul Oncologic Prof. Dr. I Chiricuta ( Site 2103)
Cluj-Napoca, Cluj, Romania
SC MNT Healthcare Europe SRL ( Site 2105)
Bucharest, , Romania
Chonnam National University Hwasun Hospital ( Site 3502)
Jeollanam-do, Jeonranamdo, South Korea
Pusan National University Yangsan Hospital ( Site 3504)
Yangsan, Kyongsangnam-do, South Korea
Pusan National University Hospital ( Site 3501)
Busan, Pusan-Kwangyokshi, South Korea
Chungnam National University Hospital ( Site 3503)
Daejeon, Taejon-Kwangyokshi, South Korea
Kyung Hee University Medical Center ( Site 3500)
Seoul, , South Korea
Korea University Guro Hospital ( Site 3505)
Seoul, , South Korea
Complejo Hospitalario Universitario A Coruna ( Site 2207)
A Coruña, La Coruna, Spain
Hospital Universitario Ramon y Cajal ( Site 2203)
Madrid, , Spain
Chang Gung Memorial Hospital- Chiayi ( Site 3611)
Chiayi City, Chiayi, Taiwan
National Cheng Kung University Hospital ( Site 3604)
Tainan, , Taiwan
Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 2504)
Chernivtsi, Chernivetska Oblast, Ukraine
Communal noncommercial enterprise of Lviv regional council "Lviv oncological regional therapeutical ( Site 2507)
Lviv, Lviv Oblast, Ukraine
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2517)
Rivne, Rivne Oblast, Ukraine
Shalimov Institute of Surgery and Transplantation Oncology department ( Site 2512)
Kyiv, , Ukraine
Universal Clinic Oberig ( Site 2506)
Kyiv, , Ukraine
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
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Related Links
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Merck Clinical Trials Information
Other Identifiers
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U1111-1307-9569
Identifier Type: REGISTRY
Identifier Source: secondary_id
2024-514500-14-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
MK-1084-007
Identifier Type: OTHER
Identifier Source: secondary_id
KANDLELIT-007
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2031240722
Identifier Type: REGISTRY
Identifier Source: secondary_id
1084-007
Identifier Type: -
Identifier Source: org_study_id