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A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Study of MK-1084 Plus Durvalumab Versus Placebo Plus Durvalumab in Participants With Locally Advanced, Unresected KRAS G12C-Mutant Non-Small Cell Lung Cancer Without Disease Progression Following Definitive Platinum-Based Chemoradiotherapy (KANDLELIT-015)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522038-29-00
Enrollment
27
Registered
2026-06-12
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced, unresected (unresectable or medically inoperable or refuse surgery) Stage II-III NSCLC with KRAS G12C mutation​

Brief summary

Progression-Free Survival (PFS)

Detailed description

Overall Survival (OS), Number of Participants Who Experience an Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE, Objective Response Rate (ORR), Duration of Response (DOR), Distant Metastasis-Free Survival (DMFS), Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) (Items 29 & 30) Combined Score, Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score, Change from Baseline in Role Functioning (EORTC QLQ-C30 Items 6 & 7) Combined Score

Interventions

DRUGDURVALUMAB

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Progression-Free Survival (PFS)

Secondary

MeasureTime frame
Overall Survival (OS), Number of Participants Who Experience an Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE, Objective Response Rate (ORR), Duration of Response (DOR), Distant Metastasis-Free Survival (DMFS), Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) (Items 29 & 30) Combined Score, Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score, Change from Baseline in Role Functioning (EORTC QLQ-C30 Items 6 & 7) Combined Score

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 13, 2026