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NCT07554339 · ClinicalTrials.gov registry record · Phase 3
A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 310
- Enrollment target
NCT07554339: Recruiting Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT07554339 is a Phase 3 study that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 310 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07554339, a Phase 3 study, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 310 participants
- Enrollment target
Study Summary
Researchers are looking for new ways to treat locally advanced non-small cell lung cancer (NSCLC) that is unresected and has a gene mutation called KRAS G12C. Researchers want to learn if calderasib (MK-1084) can be given with durvalumab, an immunotherapy, to treat NSCLC after chemotherapy and radiation therapy. The goal of this trial is to learn if participants who receive calderasib and durvalumab live longer without the cancer growing or spreading compared to participants who receive placebo and durvalumab.
Primary Outcome
PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
Interventions
- BIOLOGICAL Durvalumab
- DRUG Calderasib
- OTHER Placebo to MK-1084
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 310 participants |
| Start Date | 2026-06-18 |
| Est. Completion | 2037-08-17 |
| Phase | Phase 3 |
What NCT07554339 shows while recruiting
NCT07554339 is an interventional study that assigns participants to a tested intervention. The registered 310 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 3 interventions - of which Durvalumab is the first listed.
NCT07554339 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07554339 about?
NCT07554339 is a clinical study titled "A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015)". Researchers are looking for new ways to treat locally advanced non-small cell lung cancer (NSCLC) that is unresected and has a gene mutation called KRAS G12C. Researchers want to learn if calderasib (MK-1084) can be given with durvalumab, an immunotherapy, to treat NSCLC after chemotherapy and radia...
What is the current status of trial NCT07554339?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 310 participants. The study started on 2026-06-18. Estimated completion is 2037-08-17.
What interventions are being tested in trial NCT07554339?
The interventions under investigation include: Durvalumab (BIOLOGICAL), Calderasib (DRUG), Placebo to MK-1084 (OTHER).
Who is sponsoring clinical trial NCT07554339?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07554339's enrollment target sits among peer trials
310 1107th of 2000 higher than 892 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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