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

Last updated: March 13, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Not Recruiting

Phase

3

Condition

N/A

Treatment

Nab-paclitaxel

Carboplatin

Pembrolizumab coformulated with hyaluronidase

Clinical Study ID

NCT06212752
3475A-D77 Japan Extension
2022-501506-36-00
MK-3475A-D77
jRCT2031230049
05722015
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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-squamousNon-small Cell Lung Cancer (NSCLC).

  • Must provide archival tumor tissue sample or newly obtained core, incisional, orexcisional biopsy of a tumor lesion not previously irradiated.

  • Has a life expectancy of at least 3 months.

Exclusion

Exclusion Criteria:

  • Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of smallcell elements.

  • Has received prior systemic anticancer therapy for metastatic NSCLC.

  • Has received prior systemic anticancer therapy including investigational agentswithin 4 weeks before randomization.

  • Has received prior radiotherapy within 2 weeks of start of study intervention or hasradiation-related toxicity requiring corticosteroids.

  • Has received radiation therapy to the lung (>30 Gray) within 6 months of start ofstudy intervention.

  • Has received a live or live-attenuated vaccine within 30 days before the first doseof study intervention.

  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroidtherapy.

  • Has a known additional malignancy that is progressing or has required activetreatment within the past 3 years.

  • Has an active autoimmune disease that has required systemic treatment in past 2years.

  • 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 surgicalcomplications.

  • Has a history of allogenic tissue/solid organ transplant.

Study Design

Total Participants: 39
Treatment Group(s): 10
Primary Treatment: Nab-paclitaxel
Phase: 3
Study Start date:
June 13, 2023
Estimated Completion Date:
May 22, 2028

Study Description

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.

Connect with a study center

  • Fujita Health University ( Site 4406)

    Toyoake, Aichi 470-1192
    Japan

    Site Not Available

  • Kurume University Hospital ( Site 4412)

    Kurume, Fukuoka 830-0011
    Japan

    Site Not Available

  • Gunma Prefectural Cancer Center ( Site 4416)

    Otashi, Gunma 373-8550
    Japan

    Site Not Available

  • National Hospital Organization Hokkaido Cancer Center ( Site 4415)

    Sapporo, Hokkaido 003-0804
    Japan

    Site Not Available

  • Kanagawa Cardiovascular and Respiratory Center ( Site 4404)

    Yokohama, Kanagawa 236-0051
    Japan

    Site Not Available

  • Miyagi Cancer Center ( Site 4401)

    Natori, Miyagi 981-1293
    Japan

    Site Not Available

  • Sendai Kousei Hospital ( Site 4400)

    Sendai, Miyagi 9800873
    Japan

    Site Not Available

  • Kurashiki Central Hospital ( Site 4409)

    Kurashiki, Okayama 710-8602
    Japan

    Site Not Available

  • Kansai Medical University Hospital ( Site 4408)

    Hirakata, Osaka 573-1191
    Japan

    Site Not Available

  • Osaka Medical and Pharmaceutical University Hospital ( Site 4414)

    Takatsuki, Osaka 569-8686
    Japan

    Site Not Available

  • Saitama Prefectural Cancer Center ( Site 4402)

    Ina-machi, Saitama 362-0806
    Japan

    Site Not Available

  • Shizuoka Cancer Center ( Site 4405)

    Nagaizumi-cho,Sunto-gun, Shizuoka 411-8777
    Japan

    Site Not Available

  • Tochigi Cancer Center ( Site 4417)

    Utsunomiya, Tochigi 320-0834
    Japan

    Site Not Available

  • Juntendo University Hospital ( Site 4413)

    Bunkyo-ku, Tokyo 1138431
    Japan

    Site Not Available

  • National Hospital Organization Kyushu Cancer Center ( Site 4410)

    Fukuoka, 811-1395
    Japan

    Site Not Available

  • National Hospital Organization Kyushu Medical Center ( Site 4411)

    Fukuoka, 810-8563
    Japan

    Site Not Available

  • Osaka International Cancer Institute ( Site 4407)

    Osaka, 541-8567
    Japan

    Site Not Available

  • Nippon Medical School Hospital ( Site 4403)

    Tokyo, 113-8603
    Japan

    Site Not Available

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