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A Study of Calderasib and Other Treatments for Non-Small Cell Lung Cancer

This study is looking at new ways to treat non-small cell lung cancer (NSCLC) that has spread or cannot be removed by surgery. Researchers want to see if giving calderasib, a targeted therapy for a specific gene change called KRAS G12C, together with pembrolizumab (given as a shot under the skin) works better than pembrolizumab with chemotherapy (pemetrexed, cisplatin, or carboplatin). The main goal is to see if people live longer without their cancer growing or spreading. You may be able to join if you have advanced non-small cell lung cancer that has a KRAS G12C mutation. The study plans to enroll 675 people.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 675 participants.
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 48 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.

NCT07190248

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~675 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:CalderasibPembrolizumab (+) Berahyaluronidase alfaPemetrexedCisplatinCarboplatin

At a glance

Recruiting sites
196 of 200 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival (PFS) in Participants with Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
Measured over Up to approximately 48 months

Conditions

Non-small Cell Lung Cancer

Explore related trials

Lung Non-Small Cell CarcinomaGTPase KRas

Where it's being run

200 sites across 131 states
Turkey (Türkiye)6
Israel5
Italy5
Japan5
Taiwan5
Zhejiang4
Tokyo4
São Paulo3

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 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

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

What this trial measures

  • Progression Free Survival (PFS) in Participants with Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%Up to approximately 48 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.