UPCC 19525 A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)

Study on Investigational Medications for Advanced Non-Small Cell Lung Cancer

Enrolling By Invitation
18 years or above
All
Phase 3
675 participants needed
1 Location

Brief description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Non-small Cell Lung Cancer
  • Age: 18 years or above
  • Gender: All

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

This study investigates the use of investigational medications for treating advanced or metastatic non-small cell lung cancer (NSCLC) with a specific genetic mutation known as KRAS G12C. The purpose of this study is to compare the effects of calderasib, a targeted therapy, combined with subcutaneous pembrolizumab, against a combination of pembrolizumab and chemotherapy. Researchers aim to see if the combination therapy can prevent the cancer from growing or spreading longer than the standard treatment.

Participants in the study will receive either the investigational combination of calderasib and subcutaneous pembrolizumab or the standard chemotherapy treatment with pembrolizumab. The study will monitor patients' responses to these treatments, focusing on their ability to control the disease progression. Calderasib is designed to specifically target the KRAS G12C mutation, which is a common mutation in certain types of lung cancer.

  • Who can participate: Participants must have advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) and should not have received prior systemic anticancer therapy for their NSCLC. Individuals with well-controlled HIV on antiretroviral therapy are eligible.
  • Study details: Participants will be randomly assigned to receive either the investigational combination therapy or the standard chemotherapy. The investigational therapy includes calderasib, which targets specific cancer mutations, and subcutaneous pembrolizumab. The study aims to evaluate the effectiveness of these treatments in managing cancer progression.
Updated on 20 Jul 2026. Study ID: 25-2027
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Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

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