Recruiting

MK-1084 and Pembrolizumab for KRAS G12C-Mutant Advanced NSCLC

Study Aim

This study aims to evaluate the effectiveness of MK-1084 combined with Pembrolizumab in improving overall survival and progression-free survival for adults with KRAS G12C-mutant advanced non-small cell lung cancer.

What is being tested

Calderasib

+ Pembrolizumab

+ Placebo

DrugBiologicalOther

Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

Over 18 Years

+23 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: May 2024

See protocol details

Summary

Principal SponsorMerck Sharp & Dohme LLC

Study ContactToll Free Number

Last updated: March 17, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: May 24, 2024

Actual date on which the first participant was enrolled.

This study focuses on a treatment for a specific type of lung cancer known as non-small cell lung cancer (NSCLC). It's designed for patients with advanced or metastatic NSCLC who have a certain genetic mutation called KRAS G12C and a specific protein level (PD-L1 TPS ≥50%). The goal is to evaluate the safety and effectiveness of a combination therapy using calderasib and pembrolizumab as a first-line treatment. This research is important as it aims to improve treatment options for this specific group of lung cancer patients, potentially enhancing their care and addressing current challenges. The study compares the combination of calderasib and pembrolizumab to a placebo and pembrolizumab. Participants will be randomly assigned to one of these two groups. The study measures two main outcomes: Overall Survival (OS) and Progression-Free Survival (PFS). OS is the time from when a participant joins the study until their passing, regardless of the cause. PFS is the time from when a participant joins the study until their cancer worsens or they pass away, whichever happens first. The study uses a standard called RECIST 1.1 to determine when the cancer worsens, and this will be reviewed by an independent group of experts.

Official TitleA Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic NSCLC With PD-L1 TPS ≥50% (KANDLELIT-004)

NCT06345729

Principal SponsorMerck Sharp & Dohme LLC

Study ContactToll Free Number

Last updated: March 17, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

600 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

Criteria

7 inclusion criteria required to participate

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 human immunodeficiency virus (HIV)-infected, must have well controlled HIV on antiretroviral therapy (ART)

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16 exclusion criteria prevent from participating

Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease

Has an active infection requiring systemic therapy, with exceptions

Has uncontrolled, significant cardiovascular disease or cerebrovascular disease

Has known active central nervous system metastases and/or carcinomatous meningitis

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles and calderasib by oral tablets until discontinuation criterion is met.

Group II

Active Comparator

Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles and placebo by oral tablets once daily until discontinuation criterion is met.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 212 locations

Recruiting

CBCC Global Research, Inc. ( Site 0123)

Bakersfield, United StatesOpen CBCC Global Research, Inc. ( Site 0123) in Google Maps

Recruiting

Beverly Hills Cancer Center ( Site 0116)

Beverly Hills, United States

Recruiting

Stamford Hospital ( Site 0136)

Stamford, United States

Recruiting

Chungnam national university hospital ( Site 3602)

Junggu, South Korea

Recruiting

212 Study Centers