NCT06212752View on ClinicalTrials.gov

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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

June 13, 2023

Primary Completion Date

November 6, 2024

Study Completion Date

May 22, 2028

Conditions
Metastatic Non-small Cell Lung Cancer
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.

Trial Locations (18)

1138431

Juntendo University Hospital ( Site 4413), Bunkyo-ku

9800873

Sendai Kousei Hospital ( Site 4400), Sendai

470-1192

Fujita Health University ( Site 4406), Toyoake

830-0011

Kurume University Hospital ( Site 4412), Kurume

373-8550

Gunma Prefectural Cancer Center ( Site 4416), Otashi

003-0804

National Hospital Organization Hokkaido Cancer Center ( Site 4415), Sapporo

236-0051

Kanagawa Cardiovascular and Respiratory Center ( Site 4404), Yokohama

981-1293

Miyagi Cancer Center ( Site 4401), Natori-shi

710-8602

Kurashiki Central Hospital ( Site 4409), Kurashiki

573-1191

Kansai Medical University Hospital ( Site 4408), Hirakata

569-8686

Osaka Medical and Pharmaceutical University Hospital ( Site 4414), Takatsuki

362-0806

Saitama Prefectural Cancer Center ( Site 4402), Ina-machi

411-8777

Shizuoka Cancer Center ( Site 4405), Nagaizumi-cho,Sunto-gun

320-0834

Tochigi Cancer Center ( Site 4417), Utsunomiya

810-8563

National Hospital Organization Kyushu Medical Center ( Site 4411), Fukuoka

811-1395

National Hospital Organization Kyushu Cancer Center ( Site 4410), Fukuoka

541-8567

Osaka International Cancer Institute ( Site 4407), Osaka

113-8603

Nippon Medical School Hospital ( Site 4403), Tokyo

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY