Placebo to MK-1084 / Durvalumab / Calderasib · Phase 3 Trial

A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015)

ClinicalTrials.gov · August 7, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 3 randomized trial comparing calderasib plus durvalumab versus placebo plus durvalumab in unresected locally advanced KRAS G12C-mutant NSCLC after chemoradiation. No results have been posted to this registry; the study is actively recruiting and outcomes remain unreported.

What was studied

Phase 3, Interventional, Randomized, Parallel, Triple masking, Treatment purpose. Non-small Cell Lung Cancer; age from 18 Years. Intervention: Calderasib + Durvalumab. Compared with: Placebo + Durvalumab — Active Comparator. n = 310. 53 sites across 11 countries.

Key findings

Safety

No results have been posted to this registry record; outcomes, effect sizes, and safety data are not available for review.

Who this may help

Once results are available, this trial may inform treatment sequencing and the role of KRAS G12C inhibition with immunotherapy in locally advanced NSCLC. Clinicians should await reported outcomes before changing practice.

Plain-language summary

This is a Phase 3 trial registration with no results posted; enrollment is ongoing and outcomes have not yet been reported.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Progression-Free Survival (PFS) (assessed at Up to approximately 6 years)

DesignPhase 3, Interventional, Randomized, Parallel, Triple masking, Treatment purpose

PopulationNon-small Cell Lung Cancer; age from 18 Years

Sample size310

InterventionCalderasib + Durvalumab

ComparatorPlacebo + Durvalumab — Active Comparator

Setting53 sites across 11 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment310

PhasePHASE 3

Primary endpointProgression-Free Survival (PFS), up to approximately 6 years

Recruitment statusRECRUITING

Clinical bottom line

Caveats

No results have been posted to this registry record; outcomes, effect sizes, and safety data are not available for review.
Blinding status, randomization methodology, and statistical analysis plan are not detailed in this registry entry.
Specific eligibility criteria, treatment regimens, dosing schedules, and follow-up duration are not provided in the summary text.
Trial is still actively recruiting; final enrollment may differ from the estimated 310 participants.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Randomized, controlled phase 3 trial design with placebo comparator.

Directness

strong

Hard clinical endpoint (PFS) in relevant population with KRAS G12C NSCLC.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

Blinding status and methodological details not specified in registry entry.

Sample adequacy

strong

Planned enrollment 310 participants; adequate for phase 3 primary endpoint.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07554339). This is a study registration, not published results. Lead sponsor: Merck Sharp & Dohme LLC. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 310 participants (ESTIMATED). Conditions: Non-small Cell Lung Cancer. Interventions: DRUG: Calderasib; BIOLOGICAL: Durvalumab; OTHER: Placebo to MK-1084. Primary outcome measures: Progression-Free Survival (PFS) , Up to approximately 6 years. Brief 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT07554339Placebo to MK-1084Merck Sharp & DohmeDurvalumabCalderasibNon Small Cell Lung Cancer