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An Open-label, Multicenter, Phase 3 Randomized, Active-Comparator- Controlled Clinical Study of Pembrolizumab (MK-3475) in Combination With Sacituzumab Govitecan Versus MK-3475 Monotherapy as First-line Treatment in Participants With PD L1 TPS Greater than or Equal to 50% Metastatic Non-small Cell Lung Cancer (KEYNOTED46/EVOKE-03)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503501-11-00
Acronym
MK-3475-D46
Enrollment
166
Registered
2023-10-20
Start date
2023-02-09
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Metastatic Non-small Cell Lung Cancer

Brief summary

Progression-Free Survival (PFS), Overall Survival (OS)

Detailed description

Objective Response (OR), Duration of Response (DOR), Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30, Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30, Change from Baseline in Role Functioning (Items 6-7) Combined Score on the EORTC QLQ-C30, Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30, Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 (EORTC QLQ-LC13), Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13, Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30, TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30, TTD in Role Functioning (Items 6-7) Combined Score on the EORTC QLQ-C30, TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30, TTD in Cough Score (Item 31) on the EORTC QLQ-LC13, TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13, Number of Participants Who Experience an Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGSACITUZUMAB GOVITECAN

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), Overall Survival (OS)

Secondary

MeasureTime frame
Objective Response (OR), Duration of Response (DOR), Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30, Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30, Change from Baseline in Role Functioning (Items 6-7) Combined Score on the EORTC QLQ-C30, Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30, Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 (EORTC QLQ-LC13), Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13, Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30, TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30, TTD in Role Functio

Countries

Estonia, Germany, Greece, Italy, Latvia, Lithuania, Poland, Romania

Outcome results

None listed

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