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NCT07190248 · ClinicalTrials.gov registry record · Phase 3
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 study of Non-Small Cell Lung Cancer, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 675
- Enrollment target
- 20
- Study locations
NCT07190248: Recruiting Phase 3 study of Non-Small Cell Lung Cancer, sponsored by Merck Sharp & Dohme.
NCT07190248 is a Phase 3 study of Non-Small Cell Lung Cancer that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 675 participants, roughly in line with the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target. The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07190248, a Phase 3 study of Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 675 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
PFS is defined as the time from randomization until either documented disease progression per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. PFS as determined by blinded independent central review (BICR) will be presented.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Pemetrexed
- DRUG Calderasib
- BIOLOGICAL Pembrolizumab (+) Berahyaluronidase alfa
Study Locations (20)
Other
- Hospital Italiano de Cordoba ( Site 0308) - Córdoba
- CEMAIC ( Site 0309) - Córdoba
- IBCC - Núcleo de Pesquisa e Ensino ( Site 0417) - São Paulo
Buenos Aires
- Instituto Alexander Fleming ( Site 0311) - Ciudad Autónoma de Buenos Aires
- Instituto de Investigaciones Clinicas Mar del Plata ( Site 0300) - Mar del Plata
New South Wales
- Genesis Care- Campbelltown ( Site 2907) - Campbelltown
- Northern Beaches Hospital ( Site 2905) - Frenchs Forest
Queensland
- The Prince Charles Hospital ( Site 2903) - Brisbane
- Mater Hospital Brisbane ( Site 2906) - South Brisbane
Region M. de Santiago
- Centro de Estudios Clínicos SAGA ( Site 0503) - Santiago
- Bradfordhill ( Site 0501) - Santiago
Alabama
- Central Alabama Research ( Site 0108) - Birmingham
Connecticut
- Stamford Hospital ( Site 0126) - Stamford
Florida
- Mount Sinai Cancer Center ( Site 0137) - Miami Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 675 participants |
| Start Date | 2025-10-08 |
| Est. Completion | 2032-08-06 |
| Phase | Phase 3 |
What NCT07190248 shows while recruiting
NCT07190248 is an interventional study that assigns participants to a tested intervention. The registered 675 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target.
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT07190248 names 20 study sites across 14 states, led by Other, Buenos Aires, New South Wales.
Frequently Asked Questions
What is clinical trial NCT07190248 about?
NCT07190248 is a clinical study titled "A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)". 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 calderas...
What is the current status of trial NCT07190248?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 675 participants. The study started on 2025-10-08. Estimated completion is 2032-08-06.
What conditions does trial NCT07190248 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT07190248?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Pemetrexed (DRUG), Calderasib (DRUG), Pembrolizumab (+) Berahyaluronidase alfa (BIOLOGICAL).
Who is sponsoring clinical trial NCT07190248?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07190248 being conducted?
This trial has 20 study locations across Alabama, Connecticut, Florida, Maine, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07190248's enrollment target sits among peer trials
675 46th of 454 higher than 408 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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-
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