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Looking for participantsPhase3

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT07190248

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), Pembrolizumab (+) Berahyaluronidase alfa (biological), Pemetrexed (drug), Cisplatin (drug)
How long the study runs
Study runs about 82 months (dates as stated)
About the drug or intervention
Calderasib — drug: Administered as an oral tablet · Pembrolizumab (+) Berahyaluronidase alfa — biological: Administered as a SC injection · Pemetrexed — drug: Administered as an IV Infusion · Cisplatin — drug: Administered as an IV Infusion · Carboplatin — drug: Administered as an 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
675
Started
2025-10-08
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for non-small cell lung cancer
  • • Phase3 - 675 participants
  • • 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

Who can take part?

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

Where?

  • • Truro - Royal Cornwall Hospital ( Site 2614)
  • • London - Royal Free Hospital ( Site 2601)
  • • Birmingham - Queen Elizabeth Hospital Birmingham ( Site 2612)
  • • Leicester - Leicester Royal Infirmary ( Site 2610)

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

About This Trial

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.

Non-small Cell Lung Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

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

HIV positive

Treatment history

Treatments you must have had:

  • ✓ well controlled HIV on antiretroviral therapy (ART)

What the study is looking for

  • ✓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:...
  • ✓If human immunodeficiency virus (HIV) positive, must have well controlled HIV on antiretroviral therapy (ART)

Who cannot take part

  • ✗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...
  • ✗Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
  • ✗Has a gastrointestinal disorder affecting absorption
See the full criteria
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

Where Is This Study? (4 UK sites)

Royal Cornwall Hospital ( Site 2614)

Truro TR1 2LJ, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441872 258343

Royal Free Hospital ( Site 2601)

London NW3 2QG, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+44207794 050031911

Queen Elizabeth Hospital Birmingham ( Site 2612)

Birmingham B15 2TH, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441213712000

Leicester Royal Infirmary ( Site 2610)

Leicester LE1 5WW, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+4401162587605

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