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New antibody drug aims to stop lung cancer relapse in its tracks

NCT ID NCT07010263

Disease control Sponsor: Akeso Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial is testing whether AK112 (Ivonescimab), a bispecific antibody that targets both PD-1 and VEGF, can help prevent cancer progression in people with limited-stage small-cell lung cancer who have completed chemoradiation. About 560 participants will receive either AK112 or a placebo every three weeks. The study measures how long patients live without their cancer worsening and overall survival.

What this could mean

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

Active substance
AK112 (Ivonescimab), a bispecific antibody targeting PD-1 and VEGF
What this could lead to
If successful, this could provide a new consolidation treatment option to delay cancer progression and improve survival for patients with limited-stage small-cell lung cancer.
What could go wrong
This is a Phase 3 trial, but results are not yet known. The drug may not improve outcomes over placebo, and side effects from immune activation or anti-VEGF effects could occur.

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 560 people

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

Started

Jun 2025

Expected to finish

Jul 2029

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: Inclusion Criteria: 1. The subjects voluntarily participated in the study with full informed consent and signed written informed consent form. 2. Aged ≥18 years on day fo signing the informed consent. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Life expectancy ≥ 3 months 5. Histologically or cytologically confirmed small cell lung cancer. 6. Documented limited-stage SCLC (Stage I-III SCLC \[T any, N any, M0\] according to the American Joint Committee on Cancer Staging Manual \[AJCC Cancer Staging Manual, 8th Edition\] or the Veterans Administration Lung Study Group (VALG) stage. 7. Have Received concurrent chemoradiotherapy regimen as defined in protocol and have not progressed following concurrent chemoradiotherapy. 8. Adequate organ function. 9. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and agree to take effective contraception measures during the study drug administration and within 120 days after the last dose. Exclusion Criteria: 1. Histologically or cytological confirmed the presence of mixed small cell lung cancer or non-small cell lung cancer components. 2. Toxicities from previous anti-tumor treatments have not resolved to grade 0 or 1 based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0), or to the levels specified in inclusion/exclusion criteria, except for alopecia. 3. Symptoms or signs of primary disease deterioration that the investigator judges clinically unacceptable, such as cachexia. 4. Presence of pleural effusion, pericardial effusion, or ascites, which was clinically symptomatic or requiring frequent drainage. 5. History of active malignant tumors within the previous 5 years. 6. Received major surgery within 28 days prior to the first dose of study drug, or expected to undergo major surgery during the study period within 28 days after the first dose of study drug. 7. Uncontrolled comorbidities, including but not limited to decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis, and other related diseases.. 8. Have serious neurological or mental illnesses, including dementia and epileptic seizures. 9. Pregnant or lactating women. 10. Have cardiovascular or cerebrovascular diseases or risk factors. 11. Prior treatments with systemic non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc.) within 2 weeks before the first administration of the study drugs. Prior treatment with Chinese herbal medicine or traditional Chinese patent medicines with anti-tumor indications within 1 weeks before the first administration of the study drugs. 12. Prior treatments targeting immune mechanisms, including, but not limited to, immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy. 13. Prior treatments with anti-angiogenic therapy. 14. Subjects requiring systemic treatment with corticosteroids (\>10mg/day prednisone or equivalent dose) or other immunosuppressive drugs within 14 days prior to the first dose of study drug. 15. Known history of severe hypersensitivity reactions to other monoclonal antibodies or with a known history of allergy or hypersensitivity reactions to any of study drugs or their components. 16. Active autoimmune diseases that require systemic treatment within 2 years prior to the study, or autoimmune diseases that the investigator judges to be potentially recurrent or require planned treatment. 17. Known interstitial lung disease or non infectious pneumonia, which currently has symptoms or requires systemic corticosteroid treatment in the past,or investigator juges may affect the toxicity assessment or management related to the study treatment. 18. Known severe infection within 4 weeks prior to the first dose of study drug. Known active tuberculosis. Known active syphilis infection. Known history of immunodeficiency or positive HIV test results. 19. .Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 20. Active hepatitis B or active hepatitis C. 21. Received a live vaccine within 30 days prior to the first dose of study drug, or planning to receive a live vaccine during the study period.

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Conditions

The condition(s) this trial relates to.

small cell lung carcinoma

As listed by the trial registrant

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

Small cell lung cancer

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Affiliated Cancer Hospital of Guangxi Medical University

    RECRUITING

    Nanning, Guangxi, 530021, China

  • Anyang Cancer Hospital

    RECRUITING

    Anyang, Henan, 455000, China

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Beijing Chest Hospital

    RECRUITING

    Beijing, Beijing Municipality, 101149, China

  • Beijing Luhe Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 101149, China

  • Cancer Hospital, Chinese Academy of Medical Sciences

    RECRUITING

    Beijin, Beijin, 100021, China

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, 350014, China

  • Gansu Provincial Cancer Hospital

    RECRUITING

    Lanzhou, Gansu, 730050, China

  • General Hospital of the PLA Eastern Theater Command

    RECRUITING

    Nanjing, Jiangsu, 210002, China

  • Guangdong Provincial People's Hospital

    RECRUITING

    Guangzhou, Guangzhou, 510080, China

  • Guizhou Provincial People's Hospital

    RECRUITING

    Guiyang, Guizhou, 400042, China

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, Heilongjiang, 150081, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450008, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, Hunan, 410013, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, Hunan, 410013, China

  • Jiangmen Central Hospital

    RECRUITING

    Jiangmen, Guangdong, 529030, China

  • Jiangsu Cancer Hospital

    RECRUITING

    Nanjing, Jiangsu, 210009, China

  • Jilin Cancer Hospital

    RECRUITING

    Changchun, Jilin, 130000, China

  • Jingzhou First People's Hospital

    RECRUITING

    Jingzhou, Hubei, 434000, China

  • Linyi Cancer Hospital

    RECRUITING

    Linyi, Shandong, 276000, China

  • Linyi People's Hospital

    RECRUITING

    Linyi, Shandong, 276000, China

  • Liuzhou People's Hospital

    RECRUITING

    Liuzhou, Guangxi, 545006, China

  • Longyan First Hospital

    RECRUITING

    Longyan, Fujian, 364000, China

  • Mianyang Central Hospital

    RECRUITING

    Mianyang, Sichuan, 621000, China

  • Ningxia Medical University General Hospital

    RECRUITING

    Yinchuan, Ningxia, 750004, China

  • PLA No. 900 Hospital of the Joint Support Force

    RECRUITING

    Fuzhou, Fujian, 350025, China

  • Qingdao Central Hospital of Health and Rehabilitation Sciences University

    RECRUITING

    Qingdao, Shandong, 266000, China

  • Shandong Cancer Hospital

    RECRUITING

    Jinan, Shandong, 250117, China

  • Shandong Provincial Hospital

    RECRUITING

    Jinan, Shandong, 250021, China

  • Shanghai Pulmonary Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200433, China

  • Shanxi Cancer Hospital

    RECRUITING

    Taiyuan, Shanxi, 300013, China

  • Tangdu Hospital, The Fourth Military Medical University

    RECRUITING

    Xi’an, Shanxi, 710038, China

  • Tangshan People's Hospital

    RECRUITING

    Tangshan, Hebei, 063001, China

  • The First Affiliated Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, 400016, China

  • The First Affiliated Hospital of Gannan Medical University

    RECRUITING

    Gannan, Jiangxi, 341000, China

  • The First Affiliated Hospital of Guangxi Medical University

    RECRUITING

    Nanning, Guangxi, 530021, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of South China University

    RECRUITING

    Hengyang, Hunan, 421001, China

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, 325000, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Shaxi, Xi'an, 710061, China

  • The First Affiliated Hospital of Xinxiang Medical University

    RECRUITING

    Xinxiang, Henan, 453100, China

  • The First Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, 110001, China

  • The First Medical Center of Chinese PLA General Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100853, China

  • The Fourth Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, 050011, China

  • The Second Affiliated Hospital of Harbin Medical University

    RECRUITING

    Harbin, Heilongjiang, 150086, China

  • The Second Affiliated Hospital of Zunyi Medical University

    RECRUITING

    Zunyi, Guizhou, 563000, China

  • Tianjin Cancer Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300060, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    NOT_YET_RECRUITING

    Wuhan, Hubei, 430022, China

  • Weifang No.2 People's Hospital

    RECRUITING

    Weifang, Shangdong, 261041, China

  • Xuzhou Municipal Hospital

    RECRUITING

    Xuzhou, Jiangsu, 221002, China

  • Zaozhuang Municipal Hospital

    RECRUITING

    Zaozhuang, Shandong, 277100, China

  • Zhangzhou Municipal Hospital of Fujian Province

    RECRUITING

    Zhangzhou, Fujian, 363000, China

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