A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)-Japan Extension

NCT06212752 · tracked via the Priya Life Science Japan tracker

Sponsor

Merck Sharp & Dohme LLC

Phase

Phase 3

Started

2023-06-13

Last updated

2026-08-26

Condition(s) studied

Metastatic Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Pembrolizumab Formulated with Berahyaluronidase Alfa →Pemetrexed →Cisplatin →Carboplatin →Paclitaxel →Nab-paclitaxel →Pembrolizumab →Filgrastim →Pegylated filgrastim

Pembrolizumab Formulated with Berahyaluronidase Alfa: Pembrolizumab (+) Berahyaluronidase alfa SC will be administered for squamous and nonsquamous NSCLC as per the schedule specified in arm; participants may have been eligible for second course if they met certain protocol-specified criteria prior to study amendment 4.

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

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

Carboplatin: 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.

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

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

Pembrolizumab: Pembrolizumab by IV Infusion will be administered for squamous and nonsquamous NSCLC as per the schedule specified in arm; participants may have been eligible for second course if they met certain protocol-specified criteria prior to study amendment 4.

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

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

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

The key inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * Has histologically or cytologically confirmed diagnosis of squamous or non-squamous Non-small Cell Lung Cancer (NSCLC) * Must provide archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated * Has a life expectancy of at least 3 months Exclusion Criteria: * Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements * Has received prior systemic anticancer therapy for metastatic NSCLC * Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization * Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicity requiring corticosteroids * Has received radiation therapy to the lung (\>30 Gray) within 6 months of start of study intervention * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years * Has an active autoimmune disease that has required systemic treatment in past 2 years * Has an active infection requiring systemic therapy * Has a history of human immunodeficiency virus (HIV) infection * Has a history of Hepatitis B or C * Has not adequately recovered from major surgery or has ongoing surgical complications * Has a history of allogenic tissue/solid organ transplant

Primary outcome measure(s)

Objective Response Rate (ORR) — Up to ~ 16 months
ORR was defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR). The percentage of participants with CR or PR were reported.

Trial sites (18)

Facility	City	Region
Fujita Health University ( Site 4406)	Toyoake	Aichi-ken
Kurume University Hospital ( Site 4412)	Kurume	Fukuoka
Gunma Prefectural Cancer Center ( Site 4416)	Otashi	Gunma
National Hospital Organization Hokkaido Cancer Center ( Site 4415)	Sapporo	Hokkaido
Kanagawa Cardiovascular and Respiratory Center ( Site 4404)	Yokohama	Kanagawa
Miyagi Cancer Center ( Site 4401)	Natori-shi	Miyagi
Sendai Kousei Hospital ( Site 4400)	Sendai	Miyagi
Kurashiki Central Hospital ( Site 4409)	Kurashiki	Okayama-ken
Kansai Medical University Hospital ( Site 4408)	Hirakata	Osaka
Osaka Medical and Pharmaceutical University Hospital ( Site 4414)	Takatsuki	Osaka
Saitama Prefectural Cancer Center ( Site 4402)	Ina-machi	Saitama
Shizuoka Cancer Center ( Site 4405)	Nagaizumi-cho,Sunto-gun	Shizuoka
Tochigi Cancer Center ( Site 4417)	Utsunomiya	Tochigi
Juntendo University Hospital ( Site 4413)	Bunkyo-ku	Tokyo
National Hospital Organization Kyushu Medical Center ( Site 4411)	Fukuoka	Japan
National Hospital Organization Kyushu Cancer Center ( Site 4410)	Fukuoka	Japan
Osaka International Cancer Institute ( Site 4407)	Osaka	Japan
Nippon Medical School Hospital ( Site 4403)	Tokyo	Japan

On this site

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Other trials for the same condition

LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC Recruiting

A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77) Active, not recruiting

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Study to Compare Furmonertinib to Platinum-Based Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06212752 on ClinicalTrials.gov ↗ ← All trials in Japan