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A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508012-35-00
Acronym
MK-2870-019
Enrollment
258
Registered
2024-05-13
Start date
2024-10-02
Completion date
Unknown
Last updated
2025-12-19

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

Conditions

Newly diagnosed NSCLC with resectable clinical Stage II, IIIA or IIIB (with nodal involvement [N2])

Brief summary

Disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR)

Detailed description

Overall survival (OS), Distant metastasis-free survival (DMFS) as assessed by investigator, DFS as assessed by investigator, Lung cancer specific survival (LCSS), Number of participants who experience an Adverse Event (AE), Number of participants who discontinue study intervention due to AEs, Change from Baseline in Global health status/Quality of Life (QoL) score (Quality of Life Questionnaire (QLQ)-C30 Items 29 and 30), Change from Baseline in Physical functioning score (QLQ-C30 Items 1 to 5), Change from Baseline in Role functioning score (QLQ-C30 Items 6 and 7), Change from Baseline in Dyspnea scores (QLQ-C30 Item 8), Change from Baseline in Coughing scores (QLQ-LC24 Items 31 and 52), Change from Baseline in Chest pain scores (QLQ-LC24 Item 40)

Interventions

DRUGGEMCITABINE
DRUG-
DRUGPARACETAMOL
DRUGPACLITAXEL
DRUGPEMETREXED
DRUGCARBOPLATIN
DRUGCISPLATIN
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR)

Secondary

MeasureTime frame
Overall survival (OS), Distant metastasis-free survival (DMFS) as assessed by investigator, DFS as assessed by investigator, Lung cancer specific survival (LCSS), Number of participants who experience an Adverse Event (AE), Number of participants who discontinue study intervention due to AEs, Change from Baseline in Global health status/Quality of Life (QoL) score (Quality of Life Questionnaire (QLQ)-C30 Items 29 and 30), Change from Baseline in Physical functioning score (QLQ-C30 Items 1 to 5), Change from Baseline in Role functioning score (QLQ-C30 Items 6 and 7), Change from Baseline in Dyspnea scores (QLQ-C30 Item 8), Change from Baseline in Coughing scores (QLQ-LC24 Items 31 and 52), Change from Baseline in Chest pain scores (QLQ-LC24 Item 40)

Countries

Austria, Belgium, Czechia, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Portugal, Romania, Spain

Outcome results

None listed

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