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Calderasib and Pembrolizumab for KRAS G12C NSCLC

This study is testing a combination of two drugs, calderasib and pembrolizumab, as a first treatment for non-small cell lung cancer (NSCLC). You might be eligible if your cancer has a specific change called a KRAS G12C mutation and a high level of a protein called PD-L1 (tumor proportion score of 50% or more). Researchers want to see if calderasib, given as oral tablets, combined with pembrolizumab, given by IV, works better than pembrolizumab alone (with a placebo pill). The main goals are to see how long people live without their cancer growing (Progression-Free Survival) and how long they live overall (Overall Survival). About 600 people are expected to join this study.

Study design
This is an interventional study with an enrollment of 600 participants. It compares the combination of calderasib and pembrolizumab to pembrolizumab plus a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for Progression-Free Survival for up to approximately 42 months and for Overall Survival for up to approximately 56 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06345729

A Study of Calderasib (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)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~600 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:CalderasibPlaceboPembrolizumab

At a glance

Recruiting sites
211 of 225 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS)
Measured over Up to approximately 42 months
+1 more outcome measured

Conditions

Non-small Cell Lung Cancer

Explore related trials

Lung Non-Small Cell CarcinomaGTPase KRasProgrammed Cell Death 1 Ligand 1

Where it's being run

225 sites across 137 states
Turkey (Türkiye)7
Georgia6
Japan5
South Korea5
Spain5
Region M. de Santiago4
Beijing Municipality4
Jiangsu4

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Progression-Free Survival (PFS)Up to approximately 42 months

    PFS is defined as the time from randomization until either documented disease progression per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. PFS as determined by blinded independent central review (BICR) will be presented.

  • Overall Survival (OS)Up to approximately 56 months

    OS is defined as the time from randomization to death due to any cause.