A Study of MK-1084 Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)

Launched by MERCK SHARP & DOHME LLC · Mar 28, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new combination treatment for patients with a specific type of advanced lung cancer known as non-small cell lung cancer (NSCLC). Participants in this study will receive a medication called MK-1084 along with pembrolizumab, which is an existing cancer treatment. The goal is to see if this combination works better than a placebo (a treatment with no active ingredients) combined with pembrolizumab, particularly in helping to prolong the time patients live without their cancer getting worse and improving overall survival.

To be eligible for this trial, patients need to have a confirmed diagnosis of metastatic NSCLC with a specific genetic mutation called KRAS G12C and a high level of a protein called PD-L1 in their tumor cells. Other requirements include being at least 18 years old and having a life expectancy of at least three months. Participants can expect regular check-ups and monitoring during the trial, and they will be asked to follow certain health guidelines. It’s important to note that individuals with certain health conditions or who have received specific previous treatments may not be eligible to join.

Gender

ALL

Eligibility criteria

• The main inclusion and exclusion criteria include but are not limited to the following:
• Inclusion Criteria:
• • Has histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
• • Has newly diagnosed Stage IIIB/IIIC NSCLC, not eligible for curative resection or curative chemotherapy/radiation as determined by a multidisciplinary tumor board and/or by radiation oncologist, surgeon, and medical oncologist or Stage IV (M1a, M1b, or M1c) by American Joint Committee on Cancer (AJCC) Staging Manual, Version 8
• • Provides an archival tumor tissue sample (≤5 years) or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated to enable central laboratory testing of kirsten rat sarcoma (KRAS) G12C mutation status, PD-L1 status, and biomarker research
• • If have had adverse events (AEs) due to previous anticancer therapies, must have recovered to \< Grade 1 or baseline
• • If human immunodeficiency virus (HIV)-infected, must have well controlled HIV on antiretroviral therapy (ART)
• • If Hepatitis B surface antigen (HBsAg) positive, have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
• • If a participant has a history of Hepatitis C virus (HCV) infection, HCV viral load is undetectable
• Exclusion Criteria:
• • Has diagnosis of small cell lung cancer. For mixed tumors, if small cell elements are present, the participant is ineligible
• • Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease
• • Has known history of, or active, neurologic paraneoplastic syndrome
• • Has an active infection requiring systemic therapy, with exceptions
• • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
• • Has one or more of the following ophthalmological findings/conditions: intraocular pressure \>21 mmHg and/or any diagnosis of glaucoma, diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion, diagnosis of retinal degenerative disease
• • Has received prior systemic anticancer therapy for their locally advanced or metastatic NSCLC
• • Has received radiation therapy to the lung that is \>30 Gray within 6 months of start of study intervention
• • Has received radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not required corticosteroids, and not have had radiation pneumonitis
• • Has known active central nervous system metastases and/or carcinomatous meningitis
• • Known additional malignancy that is progressing or has required active treatment within the past 3 years
• • Has active autoimmune disease that has required systemic treatment in the past 2 years
• • Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• • Is HIV-infected and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
• • Has history of allogenic tissue/solid organ transplant
• • Has not fully recovered from any effects of major surgical procedure