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A Randomized, Open-label, Phase 3 Study of MK-2870 vs Chemotherapy (Docetaxel or Pemetrexed) in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) with EGFR Mutations or Other Genomic Alterations

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503539-16-00
Acronym
MK2870-004
Enrollment
104
Registered
2024-02-06
Start date
2025-11-11
Completion date
Unknown
Last updated
2025-11-17

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 (NSCLC)

Brief summary

Progression-free Survival (PFS) of Participants with NSCLC with Epidermal Growth Factor Receptor (EGFR) mutations, Overall Survival (OS) of Participants with NSCLC with EGFR mutations

Detailed description

PFS of All Participants with NSCLC, OS of All Participants with NSCLC, Objective Response Rate (ORR) of Participants with NSCLC with EGFR mutations, ORR of All Participants with NSCLC, Duration of Response (DOR) of All Participants with NSCLC, Change in Score from Baseline in Global Health Status/QoL Score (European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) items 29 and 30), Change in Score from Baseline in Dyspnea score (EORTC QLQ-C30 item 8), Change in Score from Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) item 31), Change in Score from Baseline in Chest pain (EORTC QLQ-LC13 item 40), Time to Deterioration from Baseline in Global Health Status/QoL Score (EORTS QLQ-C30 items 29 and 30), Time to Deterioration from Baseline in Dyspnea score (EORTC QLQ-C30 item 8), Time to Deterioration from Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) item 31), Time to Deterioration from Baseline in Chest pain (EORTC QLQ-LC13 item 40), Number of Participants Who Experience One or More Adverse Events (AEs), Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)

Interventions

DRUGPEMETREXED
DRUGDOCETAXEL
DRUGDEXAMETHASONE
DRUG-
DRUGPARACETAMOL

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) of Participants with NSCLC with Epidermal Growth Factor Receptor (EGFR) mutations, Overall Survival (OS) of Participants with NSCLC with EGFR mutations

Secondary

MeasureTime frame
PFS of All Participants with NSCLC, OS of All Participants with NSCLC, Objective Response Rate (ORR) of Participants with NSCLC with EGFR mutations, ORR of All Participants with NSCLC, Duration of Response (DOR) of All Participants with NSCLC, Change in Score from Baseline in Global Health Status/QoL Score (European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) items 29 and 30), Change in Score from Baseline in Dyspnea score (EORTC QLQ-C30 item 8), Change in Score from Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) item 31), Change in Score from Baseline in Chest pain (EORTC QLQ-LC13 item 40), Time to Deterioration from Baseline in Global Health Status/QoL Score (EORTS QLQ-C30 items 29 and 30), Time to Deterioration from Baseline in Dyspnea score (EORTC QLQ-C30 item 8), Time to Deterioration from Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) item 31), Time to

Countries

Czechia, France, Germany, Greece, Italy, Poland, Spain

Outcome results

None listed

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