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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

NCT ID: NCT06212752

Last Updated: 2025-11-12

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-13

Study Completion Date

2028-05-22

Brief Summary

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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.

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Detailed Description

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Japan extension study will require approximately six years which includes one additional year (beyond the global study's last participant last study related contact) from the time the first participant (or their legally acceptable representative) provides informed consent until the last participant's last study related contact to complete.

The Japan extension study will include participants previously enrolled in Japan in the global study for MK-3475A-D77 (NCT05722015) plus the study will continue to enroll participants in Japan until the sample size for participants in Japan reaches approximately 39.

As of Amendment 1 of the supplemental statistical analysis plan (effective date: 23 Aug 2024), patient reported outcomes will no longer be the secondary outcome measures of the study.

Conditions

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Metastatic Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy

Japanese participants with treatment-naïve metastatic NSCLC receive 790 mg of Pembrolizumab Formulated with Berahyaluronidase Alfa via subcutaneous (SC) injection on Day 1 of each 6-week cycle for18 cycles (up to approximately108 weeks) in combination with platinum doublet chemotherapy.

Group Type EXPERIMENTAL

Pembrolizumab (+) Berahyaluronidase alfa

Intervention Type BIOLOGICAL

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.

Pemetrexed

Intervention Type DRUG

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

Cisplatin

Intervention Type DRUG

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

Carboplatin

Intervention Type DRUG

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

Intervention Type DRUG

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

Nab-paclitaxel

Intervention Type DRUG

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

Filgrastim

Intervention Type DRUG

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

Pegylated filgrastim

Intervention Type DRUG

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

Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy

Japanese participants with treatment-naïve metastatic NSCLC receive 400 mg pembrolizumab intravenous (IV) infusion on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.

Group Type ACTIVE_COMPARATOR

Pemetrexed

Intervention Type DRUG

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

Cisplatin

Intervention Type DRUG

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

Carboplatin

Intervention Type DRUG

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

Intervention Type DRUG

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

Nab-paclitaxel

Intervention Type DRUG

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

Pembrolizumab

Intervention Type BIOLOGICAL

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.

Filgrastim

Intervention Type DRUG

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

Pegylated filgrastim

Intervention Type DRUG

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

Interventions

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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.

Intervention Type BIOLOGICAL

Pemetrexed

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

Intervention Type DRUG

Cisplatin

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

Intervention Type 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.

Intervention Type DRUG

Paclitaxel

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

Intervention Type DRUG

Nab-paclitaxel

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

Intervention Type DRUG

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.

Intervention Type BIOLOGICAL

Filgrastim

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

Intervention Type DRUG

Pegylated filgrastim

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

Intervention Type DRUG

Other Intervention Names

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MK-3475A Alimta Platinol-AQ Taxol Albumin-bound paclitaxel MK-3475, KEYTRUDA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Fujita Health University ( Site 4406)

Toyoake, Aichi-ken, Japan

Site Status

Kurume University Hospital ( Site 4412)

Kurume, Fukuoka, Japan

Site Status

Gunma Prefectural Cancer Center ( Site 4416)

Otashi, Gunma, Japan

Site Status

National Hospital Organization Hokkaido Cancer Center ( Site 4415)

Sapporo, Hokkaido, Japan

Site Status

Kanagawa Cardiovascular and Respiratory Center ( Site 4404)

Yokohama, Kanagawa, Japan

Site Status

Miyagi Cancer Center ( Site 4401)

Natori-shi, Miyagi, Japan

Site Status

Sendai Kousei Hospital ( Site 4400)

Sendai, Miyagi, Japan

Site Status

Kurashiki Central Hospital ( Site 4409)

Kurashiki, Okayama-ken, Japan

Site Status

Kansai Medical University Hospital ( Site 4408)

Hirakata, Osaka, Japan

Site Status

Osaka Medical and Pharmaceutical University Hospital ( Site 4414)

Takatsuki, Osaka, Japan

Site Status

Saitama Prefectural Cancer Center ( Site 4402)

Ina-machi, Saitama, Japan

Site Status

Shizuoka Cancer Center ( Site 4405)

Nagaizumi-cho,Sunto-gun, Shizuoka, Japan

Site Status

Tochigi Cancer Center ( Site 4417)

Utsunomiya, Tochigi, Japan

Site Status

Juntendo University Hospital ( Site 4413)

Bunkyo-ku, Tokyo, Japan

Site Status

National Hospital Organization Kyushu Medical Center ( Site 4411)

Fukuoka, , Japan

Site Status

National Hospital Organization Kyushu Cancer Center ( Site 4410)

Fukuoka, , Japan

Site Status

Osaka International Cancer Institute ( Site 4407)

Osaka, , Japan

Site Status

Nippon Medical School Hospital ( Site 4403)

Tokyo, , Japan

Site Status

Countries

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Japan

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

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MK-3475A-D77

Identifier Type: OTHER

Identifier Source: secondary_id

2022-501506-36-00

Identifier Type: OTHER

Identifier Source: secondary_id

jRCT2031230049

Identifier Type: OTHER

Identifier Source: secondary_id

3475A-D77 Japan Extension

Identifier Type: -

Identifier Source: org_study_id

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