CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 377 enrolled
Drug / intervention
Pembrolizumab Formulated with Berahyaluronidase Alfa +8 morebiological
Likely dose
Pemetrexed 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05722015
NCT05722015Phase 3Active
CompareCT.gov

A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Versus Intravenous Pembrolizumab, Administered With Chemotherapy, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer

Merck Sharp & Dohme LLC·interventional·Posted Feb 10, 2023·Updated Sep 11, 2025

In Brief

A Phase 3 clinical trial evaluating Pembrolizumab Formulated with Berahyaluronidase Alfa, Pemetrexed, and 7 other interventions for Metastatic Non-small Cell Lung Cancer. Active but no longer recruiting, targeting 377 participants across 110 sites in 16 countries.

Detailed Summary

This study is to assess the pharmacokinetics (PK) and safety of SC pembrolizumab formulated with berahyaluronidase alfa (MK-3475A) versus (vs) intravenous (IV) pembrolizumab (MK-3475), administered with chemotherapy in first line treatment of adult participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are pembrolizumab formulated with berahyaluronidase alfa subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Non-small Cell Lung Cancer
CountriesArgentina, Brazil, Chile, China, France, Guatemala, Hungary, Japan, Poland, Romania, South Africa, Spain, Taiwan, Thailand, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3Active
202320242025202620272028
First PostedFeb 10, 2023
Enrollment StartFeb 14, 2023
Primary CompletionJul 12, 2024
Study CompletionMay 22, 2028
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 3.4 years ago

Interventions

Pembrolizumab Formulated with Berahyaluronidase Alfabiological

Pembrolizumab (+) Berahyaluronidase alfa SC will be administered for squamous and nonsquamous NSCLC as per the schedule specified in arm; participants may be eligible for second course.

Pemetrexeddrug

Pemetrexed 500 mg/m² by IV Infusion will be administered for nonsquamous NSCLC as per the schedule specified in arm.

Cisplatindrug

Cisplatin 75 mg/m² by IV Infusion will be administered for nonsquamous and squamous NSCLC as per the schedule specified in arm.

Carboplatindrug

Carboplatin AUC 5 mg/mL/min in nonsquamous and AUC 6 mg/mL/min in squamous NSCLC will be administered as per the schedule specified in arm.

Paclitaxeldrug

Paclitaxel 200 mg/m² by IV Infusion will be administered for squamous NSCLC as per the schedule specified in arm.

Nab-paclitaxeldrug

Nab-paclitaxel 100 mg/m² by IV Infusion will be administered for squamous NSCLC as per the schedule specified in arm.

Pembrolizumabbiological

Pembrolizumab by IV Infusion will be administered for squamous and nonsquamous NSCLC as per the schedule specified in arm; participants may be eligible for second course.

Filgrastimdrug

Filgrastim will be administered as per the schedule specified for the arm.

Pegylated filgrastimdrug

Pegylated filgrastim will be administered as per the schedule specified for the arm.