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New hope for advanced cancer: Immune-Boosting drug combo tested in japan

NCT ID NCT03233139

Disease control Sponsor: Regeneron Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage study tests the safety of cemiplimab, a drug that helps the immune system fight cancer, alone or with other drugs in Japanese patients with advanced malignancies, especially lung cancer. About 146 participants will receive different combinations to see if tumors shrink and how the body handles the drugs. The goal is to find safe and effective doses for future larger studies.

What this could mean

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

Active substance
cemiplimab (also known as Libtayo), fianlimab, and various chemotherapy drugs
What this could lead to
If successful, this could show that cemiplimab and similar drugs are safe and effective for Japanese patients with advanced lung cancer, potentially expanding treatment options.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not apply to all patients. Side effects from immune-boosting drugs can be serious, and the combination treatments may not work better than existing options.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

146 people

The number who actually took part.

Started

Jun 2017

Expected to finish

Sep 2027

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

20 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.

Key Inclusion Criteria: 1. Disease types under study: * Part 1: Histologically or cytologically confirmed diagnosis of malignancy with no alternative standard-of-care therapeutic option * Part 2: Patients with histologically or cytologically documented squamous or non-squamous NSCLC with stage IIIB or IIIC or stage IV disease who received no prior systemic treatment for recurrent or metastatic NSCLC. * Patients in Part 2 NSCLC cohorts must have available archival or newly obtained formalin-fixed tumor tissue from a metastatic/recurrent site, which has not previously been irradiated. 2. ECOG (Eastern Cooperative Oncology Group) PS (Performance status) ≤1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature \[eg, light housework or office work\]). Note: Patients with ECOG PS \>1 are ineligible. 3. Patients must have been born in Japan, and their biological parents and grandparents must all have been of Japanese origin 4. Willing and able to comply with clinic visits and study-related procedures 5. For Part 2, Cohorts D and E: Available tissue for retrospective testing using assay performed by a central laboratory, as specified in the study manual. Key Exclusion Criteria: 1. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that requires treatment with systemic immunosuppressive treatments, which may suggest risk for Immune-mediated adverse event (imAE)s. The following are not exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement or psoriasis that does not require systemic treatment. 2. Untreated brain metastasis (es) that may be considered active. Patients with previously treated brain metastases may participate provided they are stable, there is no evidence of new or enlarging brain metastases, and the patient does not require any systemic corticosteroids for management of brain metastases within 4 weeks prior to the first dose of cemiplimab. 3. Immunosuppressive corticosteroid doses (\>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab. 4. Any positive test (ribonucleic acid (RNA) or Deoxyribonucleic acid (DNA) by polymerase chain reaction) for hepatitis B, hepatitis C, or human immunodeficiency virus indicating uncontrolled active or chronic infection. 5. History of pneumonitis or interstitial lung disease 6. Surgery within 1 month of first dose and radiation therapy within 2 weeks of first dose 7. Completed palliative radiation therapy within the prior 2 weeks or has not recovered from any medically significant radiation-related Adverse Event (AE) 8. Patients that have never smoked, defined as smoking ≤100 cigarettes in a lifetime (Part 2) 9. Patients with tumors tested positive for epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations, or ROS1 fusions (Part 2) Note: Other protocol defined inclusion/exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

cancer lung cancer non-small cell lung carcinoma

As listed by the trial registrant

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

Advanced malignancies

Contacts and locations

Locations

  • Gunma Prefectural Cancer Center

    Ōta, Gunma, 373-8550, Japan

  • Hiroshima City Hiroshima Citiz

    Hiroshima, 730-8518, Japan

  • Kanagawa Cancer Center - Thora

    Yokohama, Kanagawa, 241-8515, Japan

  • Kanagawa Cardiovascular and Respiratory Center

    Yokohama, Kanagawa, 236-0051, Japan

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641, Japan

  • Kansai Medical University Hirakata Hospital

    Hirakata, Osaka, 573-1191, Japan

  • Kitasato University Hospital

    Sagamihara, Kanagawa, 252-0375, Japan

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047, Japan

  • Kurashiki Central Hospital

    Kurashiki, Okayama-ken, 710-8602, Japan

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011, Japan

  • Nagasaki University Hospital

    Nagasaki, 852-8501, Japan

  • National Cancer Center Hospital - Tsukiji Campus

    Chuo Ku, Tokyo, 104-0045, Japan

  • National Hospital Organization Kinki-chuo Chest Medical Center

    Sakai-shi, Osaka, 591-8555, Japan

  • National Hospital Organization Nagoya Medical Center

    Nagoya, Aichi-ken, 460-0001, Japan

  • Osaka International Cancer Institute

    Osaka, 541-8567, Japan

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki, Osaka, 569-8686, Japan

  • Osaka Metropolitan University Hospital

    Osaka, Osaka, 545-8586, Japan

  • Saitama Cancer Center

    Shinden, Saitama, 362-0806, Japan

  • Sasebo City General Hospital

    Sasebo, Nagasaki, 857-8511, Japan

  • Tokushima University Hospital

    Tokushima, 770-8503, Japan

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