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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)

NCT07190248 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 675

Last updated 2026-05-18

No results posted yet for this study

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

Interventions

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

DRUG

Calderasib

Administered as an oral tablet

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-08
Primary Completion
2029-12-07
Completion
2032-08-06
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Chile
  • China
  • France
  • Greece
  • Hungary
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Netherlands
  • Poland
  • Romania
  • South Korea
  • Spain
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07190248 on ClinicalTrials.gov