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ACTIVE NOT RECRUITING
NCT06212752
PHASE3

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

39

Start Date

2023-06-13

Completion Date

2028-05-22

Last Updated

2025-11-12

Healthy Volunteers

No

Interventions

BIOLOGICAL

Pembrolizumab (+) Berahyaluronidase alfa

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.

DRUG

Pemetrexed

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

DRUG

Cisplatin

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

DRUG

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.

DRUG

Paclitaxel

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

DRUG

Nab-paclitaxel

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

BIOLOGICAL

Pembrolizumab

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.

DRUG

Filgrastim

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

DRUG

Pegylated filgrastim

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

Locations (18)

Fujita Health University ( Site 4406)

Toyoake, Aichi-ken, Japan

Kurume University Hospital ( Site 4412)

Kurume, Fukuoka, Japan

Gunma Prefectural Cancer Center ( Site 4416)

Otashi, Gunma, Japan

National Hospital Organization Hokkaido Cancer Center ( Site 4415)

Sapporo, Hokkaido, Japan

Kanagawa Cardiovascular and Respiratory Center ( Site 4404)

Yokohama, Kanagawa, Japan

Miyagi Cancer Center ( Site 4401)

Natori-shi, Miyagi, Japan

Sendai Kousei Hospital ( Site 4400)

Sendai, Miyagi, Japan

Kurashiki Central Hospital ( Site 4409)

Kurashiki, Okayama-ken, Japan

Kansai Medical University Hospital ( Site 4408)

Hirakata, Osaka, Japan

Osaka Medical and Pharmaceutical University Hospital ( Site 4414)

Takatsuki, Osaka, Japan

Saitama Prefectural Cancer Center ( Site 4402)

Ina-machi, Saitama, Japan

Shizuoka Cancer Center ( Site 4405)

Nagaizumi-cho,Sunto-gun, Shizuoka, Japan

Tochigi Cancer Center ( Site 4417)

Utsunomiya, Tochigi, Japan

Juntendo University Hospital ( Site 4413)

Bunkyo-ku, Tokyo, Japan

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