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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

675 Participants
are divided into 2 treatment groups

Sponsors and collaborators