Fact CheckerSign in

NCT06212752Active, not recruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 26 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
39 (actual)
First submitted
9 Jan 2024
Start date
13 Jun 2023
Primary completion date
6 Nov 2024
Lead sponsor
Merck Sharp & Dohme LLC
Diseases
Lung cancer
NCT number
NCT06212752

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 39
  • From 13 Jun 2023 to the primary completion date, 6 Nov 2024
  • 18 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 not adequately recovered from major surgery or has ongoing surgical complications

Other illness

  • Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
  • 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 a history of allogenic tissue/solid organ transplant

Who the study is looking for

  • 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

Criteria the registry did not label

  • The key inclusion and exclusion criteria include but are not limited to the following:

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (18)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Juntendo University Hospital ( Site 4413)
Coordinator of this site? Confirm its status
Bunkyo-kuJapanUnknown status
National Hospital Organization Kyushu Cancer Center ( Site 4410)
Coordinator of this site? Confirm its status
FukuokaJapanUnknown status
National Hospital Organization Kyushu Medical Center ( Site 4411)
Coordinator of this site? Confirm its status
FukuokaJapanUnknown status
Kansai Medical University Hospital ( Site 4408)
Coordinator of this site? Confirm its status
HirakataJapanUnknown status
Saitama Prefectural Cancer Center ( Site 4402)
Coordinator of this site? Confirm its status
Ina-machiJapanUnknown status
Kurashiki Central Hospital ( Site 4409)
Coordinator of this site? Confirm its status
KurashikiJapanUnknown status
Kurume University Hospital ( Site 4412)
Coordinator of this site? Confirm its status
KurumeJapanUnknown status
Shizuoka Cancer Center ( Site 4405)
Coordinator of this site? Confirm its status
Nagaizumi-cho,Sunto-gunJapanUnknown status
Miyagi Cancer Center ( Site 4401)
Coordinator of this site? Confirm its status
Natori-shiJapanUnknown status
Osaka International Cancer Institute ( Site 4407)
Coordinator of this site? Confirm its status
OsakaJapanUnknown status
Gunma Prefectural Cancer Center ( Site 4416)
Coordinator of this site? Confirm its status
OtashiJapanUnknown status
National Hospital Organization Hokkaido Cancer Center ( Site 4415)
Coordinator of this site? Confirm its status
SapporoJapanUnknown status
Sendai Kousei Hospital ( Site 4400)
Coordinator of this site? Confirm its status
SendaiJapanUnknown status
Osaka Medical and Pharmaceutical University Hospital ( Site 4414)
Coordinator of this site? Confirm its status
TakatsukiJapanUnknown status
Nippon Medical School Hospital ( Site 4403)
Coordinator of this site? Confirm its status
TokyoJapanUnknown status
Fujita Health University ( Site 4406)
Coordinator of this site? Confirm its status
ToyoakeJapanUnknown status
Tochigi Cancer Center ( Site 4417)
Coordinator of this site? Confirm its status
UtsunomiyaJapanUnknown status
Kanagawa Cardiovascular and Respiratory Center ( Site 4404)
Coordinator of this site? Confirm its status
YokohamaJapanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.