NCT07190248

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

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 675 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Calderasib	Administered as an oral tablet
BIOLOGICAL	Pembrolizumab (+) Berahyaluronidase alfa	Administered as a SC injection
DRUG	Pemetrexed	Administered as an IV Infusion
DRUG	Cisplatin	Administered as an IV Infusion
DRUG	Carboplatin	Administered as an IV Infusion

Timeline

• Start date: 2025-10-08
• Primary completion: 2029-12-07
• Completion: 2032-08-06
• First posted: 2025-09-24
• Last updated: 2026-04-13

Locations

122 sites across 21 countries: United States, Argentina, Australia, Austria, Brazil, Chile, China, France, Greece, Hungary, Israel, Italy, Japan, Malaysia, Poland, Romania, South Korea, Spain, Taiwan, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study