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

RecruitingPhase 3Ages 18 Years - anyAllMerck Sharp & Dohme LLC
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Calderasib
  • Pembrolizumab (+) Berahyaluronidase alfa
  • Pemetrexed
  • Cisplatin
  • Carboplatin
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Where

221 sites
Central Alabama Research ( Site 0108)
Birmingham, United States
University of Connecticut Health Center ( Site 0130)
Farmington, United States
Stamford Hospital ( Site 0126)
Stamford, United States
Mount Sinai Cancer Center ( Site 0137)
Miami Beach, United States
Low Country Cancer Care ( Site 0156)
Savannah, United States
Indiana University Health Arnett Cancer Center ( Site 0116)
Lafayette, United States
New England Cancer Specialists ( Site 0139)
Westbrook, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0152)
Hackensack, United States

โ€ฆand 213 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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