Skip to content

A Phase 3 Study of Pembrolizumab (MK-3475) in Combination with Concurrent Chemoradiation Therapy Followed by Pembrolizumab with or without Olaparib vs Concurrent Chemoradiation Therapy Followed by Durvalumab in Participants with Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer (NSCLC)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503591-25-00
Acronym
MK-7339-012
Enrollment
295
Registered
2023-11-15
Start date
2020-06-09
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

Non-small cell lung cancer

Brief summary

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR), Overall Survival (OS)

Detailed description

Incidence of Adverse Events (AE), Discontinuation Rate of Study Intervention Due to an AE, Objective Response Rate (ORR) Per RECIST 1.1 as assessed by BICR, Duration of Response (DOR) Per RECIST 1.1 as assessed by BICR, Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Scale Score, Change From Baseline in Cough Using the EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Item 1 Score, Change From Baseline in Chest Pain Using the EORTC QLQ-LC13 Item 10 Score, Change From Baseline in Dyspnea Using the EORTC QLQ-C30 Item 8 Score, Change From Baseline in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score, Change From Baseline in Role Functioning Using the EORTC QLQ-C30 Items 6-7 Score, Time to Deterioration (TTD) in health-related quality of life (HRQoL) Using the EORTC QLQ-C30 Items 29 and 30 Score, TTD in Cough Using the EORTC QLQ-LC13 Item 1 Score, TTD in Chest Pain Using the EORTC QLQ-LC13 Item 10 Score, TTD in Dyspnea Using the EORTC QLQ-C30 Item 8 Score, TTD in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score, TTD in Role Functioning Using the EORTC QLQ-C30 Items 6-7 Score

Interventions

DRUGMK-7339
DRUGOlaparib
DRUGPEMETREXED
DRUGETOPOSIDE
DRUGCISPLATIN
DRUGDURVALUMAB
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.
DRUGPACLITAXEL
DRUGCARBOPLATIN

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) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR), Overall Survival (OS)

Secondary

MeasureTime frame
Incidence of Adverse Events (AE), Discontinuation Rate of Study Intervention Due to an AE, Objective Response Rate (ORR) Per RECIST 1.1 as assessed by BICR, Duration of Response (DOR) Per RECIST 1.1 as assessed by BICR, Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Scale Score, Change From Baseline in Cough Using the EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Item 1 Score, Change From Baseline in Chest Pain Using the EORTC QLQ-LC13 Item 10 Score, Change From Baseline in Dyspnea Using the EORTC QLQ-C30 Item 8 Score, Change From Baseline in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score, Change From Baseline in Role Functioning Using the EORTC QLQ-C30 Items 6-7 Score, Time to Deterioration (TTD) in health-related quality of life (HRQoL) Using the EORTC QLQ-C30 Items 29 and 30 Score, TTD in Cough Using

Countries

Czechia, Estonia, France, Germany, Hungary, Italy, Latvia, Lithuania, Norway, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026