A Clinical Study of Calderasib (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: Carboplatin; Drug: Calderasib; Drug: Cisplatin; Biological: Pembrolizumab (+) Berahyaluronidase alfa; Drug: Pemetrexed

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 calderasib and subcutaneous (SC) pembrolizumab can be used to treat non-small cell lung cancer (NSCLC) when given together. Calderasib is a targeted therapy for the KRAS G12C mutation.

The goal of this study is to learn if people who receive calderasib 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

Calderasib + 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 calderasib until discontinuation criterion is met.

Treatment:

Biological: Pembrolizumab (+) Berahyaluronidase alfa

Drug: Calderasib

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:

Drug: Pemetrexed

Biological: Pembrolizumab (+) Berahyaluronidase alfa

Drug: Cisplatin

Drug: Carboplatin