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Lung cancer patients may soon get immunotherapy as a quick shot

NCT ID NCT06212752

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 27, 2026 · Updated 3 times

Summary

This study tests whether a subcutaneous (under-the-skin) injection of pembrolizumab works as well as the standard IV infusion for people with metastatic non-small cell lung cancer. About 39 Japanese adults will receive either the shot or the IV, both combined with chemotherapy. The main goal is to compare drug levels in the blood and check safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pembrolizumab with hyaluronidase (subcutaneous injection)
What this could lead to
If it works, this could offer a more convenient, faster way to receive immunotherapy for lung cancer, potentially replacing lengthy IV infusions.
What could go wrong
This is a small, early-phase study in Japanese patients only, so results may not apply broadly. The main goal is to compare drug levels, not yet to prove better outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

39 people

The number who actually took part.

Started

Jun 2023

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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-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

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic non-small cell lung cancer

Contacts and locations

Locations

  • Fujita Health University ( Site 4406)

    Toyoake, Aichi-ken, 470-1192, Japan

  • Gunma Prefectural Cancer Center ( Site 4416)

    Otashi, Gunma, 373-8550, Japan

  • Juntendo University Hospital ( Site 4413)

    Bunkyo-ku, Tokyo, 1138431, Japan

  • Kanagawa Cardiovascular and Respiratory Center ( Site 4404)

    Yokohama, Kanagawa, 236-0051, Japan

  • Kansai Medical University Hospital ( Site 4408)

    Hirakata, Osaka, 573-1191, Japan

  • Kurashiki Central Hospital ( Site 4409)

    Kurashiki, Okayama-ken, 710-8602, Japan

  • Kurume University Hospital ( Site 4412)

    Kurume, Fukuoka, 830-0011, Japan

  • Miyagi Cancer Center ( Site 4401)

    Natori-shi, Miyagi, 981-1293, Japan

  • National Hospital Organization Hokkaido Cancer Center ( Site 4415)

    Sapporo, Hokkaido, 003-0804, Japan

  • National Hospital Organization Kyushu Cancer Center ( Site 4410)

    Fukuoka, 811-1395, Japan

  • National Hospital Organization Kyushu Medical Center ( Site 4411)

    Fukuoka, 810-8563, Japan

  • Nippon Medical School Hospital ( Site 4403)

    Tokyo, 113-8603, Japan

  • Osaka International Cancer Institute ( Site 4407)

    Osaka, 541-8567, Japan

  • Osaka Medical and Pharmaceutical University Hospital ( Site 4414)

    Takatsuki, Osaka, 569-8686, Japan

  • Saitama Prefectural Cancer Center ( Site 4402)

    Ina-machi, Saitama, 362-0806, Japan

  • Sendai Kousei Hospital ( Site 4400)

    Sendai, Miyagi, 9800873, Japan

  • Shizuoka Cancer Center ( Site 4405)

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

  • Tochigi Cancer Center ( Site 4417)

    Utsunomiya, Tochigi, 320-0834, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.