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Small Cell Lung CancerPhase 3AK112-311NCT07010263

A Study of AK112 as Consolidation Treatment for Patients With Limited Stage Small-cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy

A Phase 3 study testing AK112 in people with Small Cell Lung Cancer, run by Akeso at 53 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a randomized, double-blind, phase III clinical study to compare the efficacy and safety of AK112 to placebo as consolidation treatment for patients with limited stage small cell lung cancer who have not progressed following concurrent chemoradiation therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
AK112
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
560 participants
Where
53 sitesChina
Study dates
13 Jun 2025to 31 Jul 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subjects voluntarily participated in the study with full informed consent and signed written informed consent form.
  • Aged ≥18 years on day fo signing the informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy ≥ 3 months
  • Histologically or cytologically confirmed small cell lung cancer.
  • 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.
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  • Have Received concurrent chemoradiotherapy regimen as defined in protocol and have not progressed following concurrent chemoradiotherapy.
  • Adequate organ function.
  • 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.

Who cannot join

  • Histologically or cytological confirmed the presence of mixed small cell lung cancer or non-small cell lung cancer components.
  • 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.
  • Symptoms or signs of primary disease deterioration that the investigator judges clinically unacceptable, such as cachexia.
  • Presence of pleural effusion, pericardial effusion, or ascites, which was clinically symptomatic or requiring frequent drainage.
  • History of active malignant tumors within the previous 5 years.
  • 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.
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  • 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..
  • Have serious neurological or mental illnesses, including dementia and epileptic seizures.
  • Pregnant or lactating women.
  • Have cardiovascular or cerebrovascular diseases or risk factors.
  • 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.
  • Prior treatments targeting immune mechanisms, including, but not limited to, immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy.
  • Prior treatments with anti-angiogenic therapy.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • .Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
  • Active hepatitis B or active hepatitis C.
  • 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.

Trial locations and contacts

53 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Zhifang Yao, M.D. contact

+86-0760-89873999

clinicaltrials@akesobio.com

53 sites in 1 country

China53 sites, 53 recruiting

  • Anyang Cancer Hospital

    Anyang, Henan, 455000

    Anping Zheng, M.D.

    Anping Zheng, M.D.

    Recruiting

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijin, Beijin, 100021

    Zhijie Wang, M.D.

    Zhijie Wang, M.D.

    Recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Rong Yu, M.D.

    Rong Yu, M.D.

    Recruiting

  • The First Medical Center of Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

    Yi Hu, M.D.

    Yi Hu, M.D.

    Recruiting

  • Beijing Chest Hospital

    Beijing, Beijing Municipality, 101149

    Gen Lin, M.D.

    Gen Lin, M.D.

    Recruiting

  • Beijing Luhe Hospital, Capital Medical University

    Beijing, Beijing Municipality, 101149

    Dong Yan, M.D.

    Dong Yan, M.D.

    Recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin, 130000

    Haifeng Liu, M.D.

    Haifeng Liu, M.D.

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Yongzhong Luo, M.D.

    Yongzhong Luo, M.D.

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Lin Wu, M.D.

    Lin Wu, M.D.

    Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

    Ge Luo, M.D.

    Ge Luo, M.D.

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

    Haipeng Xu, M.D.

    Haipeng Xu, M.D.

    Recruiting

  • PLA No. 900 Hospital of the Joint Support Force

    Fuzhou, Fujian, 350025

    Zongyang Yu, M.D.

    Zongyang Yu, M.D.

    Recruiting

  • The First Affiliated Hospital of Gannan Medical University

    Gannan, Jiangxi, 341000

    Jie Li, M.D.

    Jie Li, M.D.

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangzhou, 510080

    Jing Li, M.D.

    Jing Li, M.D.

    Recruiting

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou, 400042

    Yu Zhang, M.D.

    Yu Zhang, M.D.

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

    Yan Yu, M.D.

    Yan Yu, M.D.

    Recruiting

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150086

    Yu Yang, M.D.

    Yu Yang, M.D.

    Recruiting

  • The First Affiliated Hospital of South China University

    Hengyang, Hunan, 421001

    Yuehua Li, M.D.

    Yuehua Li, M.D.

    Recruiting

  • Jiangmen Central Hospital

    Jiangmen, Guangdong, 529030

    Gengsheng Yu, M.D.

    Gengsheng Yu, M.D.

    Recruiting

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021

    Zhe Yang, M.D.

    Zhe Yang, M.D.

    Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

    Hui Zhu, M.D.

    Hui Zhu, M.D.

    Recruiting

  • Jingzhou First People's Hospital

    Jingzhou, Hubei, 434000

    Yonghua Yang, M.D.

    Yonghua Yang, M.D.

    Recruiting

  • Gansu Provincial Cancer Hospital

    Lanzhou, Gansu, 730050

    Shihong Wei, M.D.

    Shihong Wei, M.D.

    Recruiting

  • Linyi Cancer Hospital

    Linyi, Shandong, 276000

    Jianhua Shi, M.D.

    Jianhua Shi, M.D.

    Recruiting

  • Linyi People's Hospital

    Linyi, Shandong, 276000

    Zhongmin Zhang, M.D.

    Xueliang Xu, M.D.

    Recruiting

  • Liuzhou People's Hospital

    Liuzhou, Guangxi, 545006

    Leili Wang, M.D.

    Leili Wang, M.D.

    Recruiting

  • Longyan First Hospital

    Longyan, Fujian, 364000

    Chunyue Wang, M.D.

    Chunyue Wang, M.D.

    Recruiting

  • Mianyang Central Hospital

    Mianyang, Sichuan, 621000

    Xiaobo Du, M.D.

    Xiaobo Du, M.D.

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Longhua Sun, M.D.

    Longhua Sun, M.D.

    Recruiting

  • General Hospital of the PLA Eastern Theater Command

    Nanjing, Jiangsu, 210002

    Xiangfeng Lv, M.D.

    Xiangfeng Lv, M.D.

    Recruiting

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210009

    Lin Shi, M.D.

    Lin Shi, M.D.

    Recruiting

  • Affiliated Cancer Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

    Jiangqiong Huang, M.D.

    Jiangqiong Huang, M.D.

    Recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

    Qing Bu, M.D.

    Qing Bu, M.D.

    Recruiting

  • Qingdao Central Hospital of Health and Rehabilitation Sciences University

    Qingdao, Shandong, 266000

    Zhen Zhang, M.D.

    Xiaotao Zhang, M.D.

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Zhengfei Zhu, M.D.

    Zhengfei Zhu, M.D.

    Recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

    Fengying Wu, M.D.

    Fengying Wu, M.D.

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Shaxi, Xi'an, 710061

    Yu Yao, M.D.

    Yu Yao, M.D.

    Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

    Bo Jin, M.D.

    Bo Jin, M.D.

    Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011

    Jun Wang, M.D.

    Jun Wang, M.D.

    Recruiting

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi, 300013

    Hongwei Li, M.D.

    Hongwei Li, M.D.

    Recruiting

  • Tangshan People's Hospital

    Tangshan, Hebei, 063001

    Zhiwu Wang, M.D.

    Zhiwu Wang, M.D.

    Recruiting

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300060

    Dingzhi Huang, M.D.

    Dingzhi Huang, M.D.

    Recruiting

  • Weifang No.2 People's Hospital

    Weifang, Shangdong, 261041

    Kunning Yang, M.D.

    Kunning Yang, M.D.

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

    Yuping Li, M.D.

    Yuping Li, M.D.

    Recruiting

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

    Wuhan, Hubei, 430022

    Xiaorong Dong, M.D.

    Xiaorong Dong, M.D.

    Not yet recruiting

  • Tangdu Hospital, The Fourth Military Medical University

    Xi’an, Shanxi, 710038

    Xiaolong Yan, M.D.

    Xiaolong Yan, M.D.

    Recruiting

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan, 453100

    Qingqin Zhang, M.D.

    Qingqin Zhang, M.D.

    Recruiting

  • Xuzhou Municipal Hospital

    Xuzhou, Jiangsu, 221002

    Haitao Yin, M.D.

    Haitao Yin, M.D.

    Recruiting

  • Ningxia Medical University General Hospital

    Yinchuan, Ningxia, 750004

    Yanyang Wang, M.D.

    Yanyang Wang, M.D.

    Recruiting

  • Zaozhuang Municipal Hospital

    Zaozhuang, Shandong, 277100

    Shifeng Kan, M.D.

    Shifeng Kan, M.D.

    Recruiting

  • Zhangzhou Municipal Hospital of Fujian Province

    Zhangzhou, Fujian, 363000

    Li Lin, M.D.

    Li Lin, M.D.

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

    Yanqiu Zhao, M.D.

    Yanqiu Zhao, M.D.

    Recruiting

  • The Second Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou, 563000

    Shiyun Xing, M.D.

    Shiyun Xing, M.D.

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Phase III Clinical Study of Comparing the Efficacy and Safety of AK112 (PD-1/VEGF Bispecific Antibody) Versus Placebo as Consolidation Treatment for Patients With Limited Stage Small-Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy

This is a randomized, double-blind, phase III clinical study to compare the efficacy and safety of AK112 to placebo as consolidation treatment for patients with limited stage small cell lung cancer who have not progressed following concurrent chemoradiation therapy.

Being tested
AK112, Placebo
Keywords
AK112, Ivonescimab
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AK112Drug

    Also called Ivonescimab

    AK112 20mg/kg, intravenous [IV]),Q3W

  • PlaceboOther

    Placebo, intravenous [IV]),Q3W

Study groups in NCT07010263
Study groupRoleWhat they receive
Ak112 armExperimentalAK112 intravenous [IV]),every 3 weeks
Receives: Drug: AK112
Placebo armPlacebo comparatorPlacebo intravenous [IV]),every 3 weeks
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival(PFS) assessed by Blinded independent center review(BIRC)

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST v1.1

    Measured: Approximately 6 years

  2. Overall Survival (OS)

    OS is defined as the time from randomization or first dosing to death due to any cause.

    Measured: Approximately 6 years

Secondary outcomes (8)

  1. PFS assessed by investigator per RECIST v1.1

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST v1.1

    Measured: Approximately 6 years

  2. Objective Response Rate (ORR) assessed by BICR Per RECIST v1.1

    Measured: Approximately 6 years

  3. ORR assessed by investigator Per RECIST v1.1

    Measured: Approximately 6 years

  4. Disease control rate(DCR) assessed by BICR per RECIST v1.1

    Measured: Approximately 6 years

  5. DCR assessed by investigator per RECIST v1.1

    Measured: Approximately 6 years

  6. Duration of Response (DOR) assessed by BICR per RECIST v1.1

    Measured: Approximately 6 years

  7. DOR assessed by investigator per RECIST v1.1

    Measured: Approximately 6 years

  8. Number of participants with adverse event (AE)

    The number of participants experiencing an AE and the severity of AEs will be assessed. AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.

    Measured: Approximately 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2025
  2. Study start13 Jun 2025
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel assignment
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
560 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07010263
Sponsor's protocol ID
AK112-311
Acronym
AK112-311
Status last verified
Mar 2026
First submitted
25 May 2025
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AK112 in people with Small Cell Lung Cancer, run by Akeso at 53 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhifang Yao, M.D. (+86-0760-89873999, clinicaltrials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival(PFS) assessed by Blinded independent center review(BIRC) (time frame: Approximately 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07010263.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.

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