NCT04380636|Active Not RecruitingPhase 3DMCFDA Drug

Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012)

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)

Merck Sharp & Dohme LLC ClinicalTrials.gov

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7 other identifiers

7339-012MK-7339-012KEYLYNK-0122053522023-503591-25-00U1111-1287-54772019-003237-41

Study Type

interventional

Target

870

Locations

25 countries

Sites

203

Timeline

RegisteredMay 2020

StartedJul 2020

CompletionFeb 2027

Brief Summary

The purpose of this study is to assess the efficacy and safety of pembrolizumab in combination with concurrent chemoradiation therapy followed by either pembrolizumab with olaparib placebo (Arm 1) or with olaparib (Arm 2) compared to concurrent chemoradiation therapy followed by durvalumab (Arm 3) in participants with unresectable, locally advanced NSCLC. Arms 1 and 2 will be studied in a double-blind design and Arm 3 will be open-label. The primary hypotheses are:

1.Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab with olaparib is superior to concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival (PFS) and overall survival (OS)
2.Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab is superior to concurrent chemoradiation therapy followed by durvalumab with respect to PFS and OS

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

870

participants targeted

Target at P75+ for phase_3

Timeline

10mo left

Started Jul 2020

Longer than P75 for phase_3

Geographic Reach

25 countries

203 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.6 years study duration

Study Progress88%

Jul 2020Feb 2027

First Submitted

Initial submission to the registry

May 5, 2020

Completed

3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2020

Completed

2 months until next milestone

Study Start

First participant enrolled

July 6, 2020

Completed

6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2026

Expected

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2027

Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

6 years

First QC Date

May 5, 2020

Last Update Submit

August 13, 2025

Conditions

Lung Neoplasms Carcinoma, Non-Small-Cell Lung

Keywords

Programmed Cell Death Receptor 1 (PD-1, PD1)Programmed Cell Death Receptor Ligand 1 (PD-L1, PDL1)Programmed Cell Death Receptor Ligand 2 (PD-L2, PDL2)polyadenosine 5'diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor

Outcome Measures

Primary Outcomes (2)

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)
PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
Up to approximately 48 months
Overall Survival (OS)
OS is the time from randomization to death due to any cause.
Up to approximately 72 months

Secondary Outcomes (16)

Incidence of Adverse Events (AE)
Up to approximately 72 months
Discontinuation Rate of Study Intervention Due to an Adverse Event (AE)
Up to approximately 72 months
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Up to approximately 72 months
Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Up to approximately 72 months
Change from Baseline in EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Scale Score
Baseline (at randomization) and at the end of study (approximately 72 months post randomization)
+11 more secondary outcomes

Study Arms (3)

pembrolizumab+chemoradiation→pembrolizumab+olaparib placebo

EXPERIMENTAL

Participants will receive pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gray (Gy) over 6 weeks) followed by pembrolizumab plus olaparib placebo twice a day (BID) for approximately 1 year.

Biological: PembrolizumabDrug: Placebo for olaparibDrug: EtoposideDrug: CarboplatinDrug: CisplatinDrug: PaclitaxelDrug: PemetrexedRadiation: Thoracic Radiotherapy

pembrolizumab+chemoradiation→pembrolizumab+olaparib

EXPERIMENTAL

Participants will receive pembrolizumab 200 mg IV Q3W in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gy over 6 weeks) followed by pembrolizumab plus olaparib 300 mg BID for approximately 1 year.

Biological: PembrolizumabDrug: OlaparibDrug: EtoposideDrug: CarboplatinDrug: CisplatinDrug: PaclitaxelDrug: PemetrexedRadiation: Thoracic Radiotherapy

chemoradiation→durvalumab

ACTIVE COMPARATOR

Participants will receive 3 cycles of the investigator's choice of platinum doublet chemotherapy with concurrent standard thoracic radiotherapy (60 Gy over 6 weeks) followed by durvalumab 10 mg/kg every 2 weeks (Q2W) for approximately 1 year.

Drug: EtoposideDrug: CarboplatinDrug: CisplatinDrug: PaclitaxelDrug: PemetrexedRadiation: Thoracic RadiotherapyDrug: Durvalumab

Interventions

PembrolizumabBIOLOGICAL

intravenous (IV) infusion

Also known as: KEYTRUDA®, MK-3475

pembrolizumab+chemoradiation→pembrolizumab+olaparibpembrolizumab+chemoradiation→pembrolizumab+olaparib placebo

OlaparibDRUG

oral tablets

Also known as: LYNPARZA®, MK-7339, AZD2281, KU-0059436

pembrolizumab+chemoradiation→pembrolizumab+olaparib

Placebo for olaparibDRUG

oral tablets

pembrolizumab+chemoradiation→pembrolizumab+olaparib placebo

EtoposideDRUG

IV infusion

Also known as: VEPESID®