A Study of AK112 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Progression-Free Survival(PFS) assessed by Blinded independent center review(BIRC) — Approximately 6 years 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
Overall Survival (OS) — Approximately 6 years OS is defined as the time from randomization or first dosing to death due to any cause.
Trial sites (53)
Facility
City
Region
Status
Beijing Cancer Hospital
Beijing
Beijing Municipality
Recruiting
The First Medical Center of Chinese PLA General Hospital
Beijing
Beijing Municipality
Recruiting
Beijing Chest Hospital
Beijing
Beijing Municipality
Recruiting
Beijing Luhe Hospital, Capital Medical University
Beijing
Beijing Municipality
Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijin
Beijin
Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Chongqing Municipality
Recruiting
Fujian Cancer Hospital
Fuzhou
Fujian
Recruiting
PLA No. 900 Hospital of the Joint Support Force
Fuzhou
Fujian
Recruiting
Longyan First Hospital
Longyan
Fujian
Recruiting
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou
Fujian
Recruiting
Gansu Provincial Cancer Hospital
Lanzhou
Gansu
Recruiting
Jiangmen Central Hospital
Jiangmen
Guangdong
Recruiting
Liuzhou People's Hospital
Liuzhou
Guangxi
Recruiting
Affiliated Cancer Hospital of Guangxi Medical University
Nanning
Guangxi
Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning
Guangxi
Recruiting
Guangdong Provincial People's Hospital
Guangzhou
Guangzhou
Recruiting
Guizhou Provincial People's Hospital
Guiyang
Guizhou
Recruiting
The Second Affiliated Hospital of Zunyi Medical University
Zunyi
Guizhou
Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang
Hebei
Recruiting
Tangshan People's Hospital
Tangshan
Hebei
Recruiting
Harbin Medical University Cancer Hospital
Harbin
Heilongjiang
Recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin
Heilongjiang
Recruiting
Anyang Cancer Hospital
Anyang
Henan
Recruiting
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang
Henan
Recruiting
Henan Cancer Hospital
Zhengzhou
Henan
Recruiting
Jingzhou First People's Hospital
Jingzhou
Hubei
Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Hubei
Not Yet Recruiting
Hunan Cancer Hospital
Changsha
Hunan
Recruiting
Hunan Cancer Hospital
Changsha
Hunan
Recruiting
The First Affiliated Hospital of South China University
Hengyang
Hunan
Recruiting
General Hospital of the PLA Eastern Theater Command
Nanjing
Jiangsu
Recruiting
Jiangsu Cancer Hospital
Nanjing
Jiangsu
Recruiting
Xuzhou Municipal Hospital
Xuzhou
Jiangsu
Recruiting
The First Affiliated Hospital of Gannan Medical University
Gannan
Jiangxi
Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang
Jiangxi
Recruiting
Jilin Cancer Hospital
Changchun
Jilin
Recruiting
The First Hospital of China Medical University
Shenyang
Liaoning
Recruiting
Ningxia Medical University General Hospital
Yinchuan
Ningxia
Recruiting
Shandong Provincial Hospital
Jinan
Shandong
Recruiting
Shandong Cancer Hospital
Jinan
Shandong
Recruiting
+ 13 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.