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Looking for participantsPhase3

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)

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT06345729

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Calderasib (drug), Placebo (other), Pembrolizumab (biological)
How long the study runs
Study runs about 81 months (dates as stated)
About the drug or intervention
Calderasib — drug: Oral tablets · Placebo — other: Oral tablets · Pembrolizumab — biological: IV infusion
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
348
Started
2024-05-24
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for non-small cell lung cancer
  • • Phase3 - 348 participants
  • • This is a study evaluating the efficacy and safety of calderasib with pembrolizumab as first-line treatment in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with non-small cell lung cancer

Where?

  • • Milton Keynes - Milton Keynes Hospital ( Site 2304)
  • • Exeter - Royal Devon & Exeter Hospital-Oncology ( Site 2302)

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This is a study evaluating the efficacy and safety of calderasib with pembrolizumab as first-line treatment in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There is one primary study hypothesis: Combination of calderasib and pembrolizumab is superior to placebo plus pembrolizumab with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

More detail

Per Protocol Amendment 04, overall survival (OS) was moved to be a secondary outcome measure. Additionally, no new participants will be offered Second Course treatment for pembrolizumab.

Non-small Cell Lung Cancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

KRASPD-L1

Treatment history

Treatments you must have had:

  • ✓ recovered to \< Grade 1 or baseline
  • ✓ well controlled HIV on antiretroviral therapy (ART)

What the study is looking for

  • ✓Has confirmed by testing a sample diagnosis of non-small cell lung cancer (NSCLC)
  • ✓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...
  • ✓If a participant has a history of Hepatitis C virus (HCV) infection, HCV viral load is undetectable

Who cannot take part

  • ✗Has diagnosis of small cell lung cancer. For mixed tumors, if small cell elements are present, the participant is...
  • ✗Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of...
  • ✗Has known history of, or active, neurologic paraneoplastic syndrome
  • ✗Has an active infection requiring treatment that goes through your whole body, with exceptions
  • ✗Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
See the full 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 sample (≤5 years) or newly obtained core, incisional, or excisional biopsy or fine needle aspirate (FNA) of a tumor lesion, not previously irradiated to enable central laboratory testing of kirsten rat sarcoma (KRAS) G12C mutation status, programmed cell death ligand 1 (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 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 to non-central nervous system (CNS) disease 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 CNS 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

Where Is This Study? (2 UK sites)

Milton Keynes Hospital ( Site 2304)

Milton Keynes MK6 5LD, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator01908 997609

Royal Devon & Exeter Hospital-Oncology ( Site 2302)

Exeter EX2 5DW, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+44 (0) 1392 402869

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10