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Can a new drug boost chemotherapy for a rare cancer?

NCT ID NCT07720193

Disease control Sponsor: Nanjing Leads Biolabs Co.,Ltd 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Last updated Sep 02, 2026 · Updated 4 times

Summary

This phase III trial is testing whether adding an experimental drug called LBL-024 to standard chemotherapy can help people with advanced extrapulmonary neuroendocrine carcinoma (EP-NEC), a rare and aggressive cancer. Participants will receive either LBL-024 or a placebo alongside etoposide and cisplatin or carboplatin. The study aims to see if the combination improves overall survival compared to chemotherapy alone.

What this could mean

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

Active substance
an experimental drug called LBL-024 combined with standard chemotherapy (etoposide plus cisplatin or carboplatin)
What this could lead to
If it works, this could offer a new first-line treatment option for people with advanced extrapulmonary neuroendocrine carcinoma, potentially improving survival.
What could go wrong
This is an early-phase trial, so the drug may not prove more effective than chemotherapy alone. Side effects from the combination could also be significant.

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

About 280 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

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.

Inclusion Criteria: 1. Agrees to follow the investigational treatment protocol, visit schedule and laboratory test, comply with other requirements of the protocol, voluntarily enroll, and sign a written informed consent. 2. Age ≥ 18 years (inclusive) at the time of signing informed consent. 3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1. 4. expected survival time of at least 12 weeks. 5. According to RECIST 1.1, participants were required to have at least one measurable lesion. 6. Male of childbearing potential and Females of childbearing age are willing to take highly effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug. Exclusion Criteria: 1. Diagnosed with Mixed neuroendocrine-non endocrine neoplasm (MiNENs). 2. Major surgery (other than aspiration biopsy) within 28 days prior to the first dose of study drug or significant trauma,or required to undergo scheduled surgery during the trial. 3. Use of immunomodulatory drugs within 14 days before the first use of study drug,Including but not limited to thymopeptide, interleukins, interferon, etc. 4. Patients with active infection requiring intravenous anti-infective therapy within 2 weeks prior to the first dose of study drug. 5. serious cardiac and cerebrovascular disorder. 6. History of immunodeficiency including HIV antibody test positive. 7. patients with active hepatitis B or C. 8. Women during pregnancy or lactation. 9. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

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Conditions

The condition(s) this trial relates to.

neuroendocrine carcinoma

As listed by the trial registrant

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

Advanced extrapulmonary neuroendocrine carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    28 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Beijing GoBroad Hospital

    Beijing, Beijing Municipality, 100070, China

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 30012, China

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032, China

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014, China

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001, China

  • Gansu Cancer Hospital

    Lanzhou, Gansu, 730050, China

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi, 530200, China

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003, China

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013, China

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025, China

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117, China

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030013, China

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072, China

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

  • The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008, China

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221006, China

  • The First Affiliated Hospital of Henan University of Science & Technology

    Luoyang, Henan, 471023, China

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong, 510630, China

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710061, China

  • The First Affiliated Hospital,Sun Yat-sen University

    Guangzhou, Guangdong, 510062, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330200, China

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060, China

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650118, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

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