A Clinical Study of MK-1084 and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 3

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: MK-1084; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed; Biological: Pembrolizumab (+) Berahyaluronidase alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT07190248

MK-1084-007 (Other Identifier)

1084-007

jRCT2031240722 (Registry Identifier)

KANDLELIT-007 (Other Identifier)

U1111-1307-9569 (Registry Identifier)

2024-514500-14-00 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 675 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

• Has diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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675 participants in 2 patient groups

MK-1084 + Pembrolizumab (+) Berahyaluronidase alfa

Experimental group

Description:

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.

Treatment:

Biological: Pembrolizumab (+) Berahyaluronidase alfa

Drug: MK-1084

Pembrolizumab (+) Berahyaluronidase alfa + Chemotherapy

Active Comparator group

Description:

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).

Treatment:

Biological: Pembrolizumab (+) Berahyaluronidase alfa

Drug: Pemetrexed

Drug: Cisplatin

Drug: Carboplatin