A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours[Substudy 01(NSCLC)]
NCT ID: NCT06783647
Last Updated: 2026-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
230 participants
INTERVENTIONAL
2025-06-11
2026-12-24
Brief Summary
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Detailed Description
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Cohort 1 A:This cohort will have a safety run-in period in which a small number of subjects will be enrolled to receive LBL-024 Combination Administration. After the subjects completed the 21-day safety observation, the sponsor and investigator jointly assessed the safety and tolerability of the combination drugs. If the safety and tolerability of combination drugs are good, the Cohort will continue to enroll subjects for the extension study of combination administration. Eligible subjects will be randomized in a 1: 1 ratio to Arm A or Arm B.
Cohort 1 B:This cohort will have a safety run-in period, a small number of subjects will be enrolled to receive LBL-024 Combination Administration.After the subjects completed the 21-day safety observation, the sponsor and investigator jointly assessed the safety and tolerability of the combination drugs.If the safety and tolerability of combination drugs are good, the Cohort will continue to enroll subjects for the extension study of combination administration.
Cohort 2 A:This cohort will have a safety run-in period, a small number of subjects will be enrolled to receive LBL-024 Combination Administration, and after a period of time, LBL-024 and pemetrexed will be used for maintenance treatment.After completing the 21-day safety observation, the safety and tolerability of combination drugs will be assessed. If the safety and tolerability of combination drugs are good, this cohort will continue to enroll subjects.
Cohort 2 B: This cohort will have a safety run-in period, a small number of subjects will be enrolled to receive LBL-024 Combination Administration and after a period of time, and then use LBL-024 for maintenance treatment. After completing the 21-day safety observation, the safety and tolerability of combination drugs will be assessed. If the safety and tolerability of combination drugs are good, this cohort will continue to enroll subjects.
This study will enroll up to 230 subjects.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LBL-024+Docetaxel/LBL-024+Bevacizumab+Docetaxel
Cohort 1 A：
Subjects were treated with LBL-024 combined with docetaxel
or LBL-024 combined with bevacizumab and docetaxel,
Intravenous infusion.
LBL-024 for Injection
intravenous infusion.
Docetaxel Injection
intravenous infusion.
Bevacizumab Injection
intravenous infusion.
LBL-024+Docetaxel
Cohort 1 B：
Subjects were treated with LBL-024 combined with docetaxel,
Intravenous infusion.
LBL-024 for Injection
intravenous infusion.
Docetaxel Injection
intravenous infusion.
LBL-024+Pemetrexed Disodium+Carboplatin/LBL-024+pemetrexed Disodium
Cohort 2 A：
Subjects were treated with LBL-024 combined with pemetrexed and carboplatin,
after a period of time,LBL-024 and pemetrexed were used for maintenance treatment.
Intravenous infusion.
LBL-024 for Injection
intravenous infusion.
Pemetrexed Disodium for Injection
intravenous infusion.
Carboplatin Injection
intravenous infusion.
LBL-024+Paclitaxel+Carboplatin/LBL-024
Cohort 2 B：
Subjects were treated with LBL-024 combined with paclitaxel and carboplatin,
after a period of time,LBL-024 was used for maintenance treatment.
Intravenous infusion.
LBL-024 for Injection
intravenous infusion.
Paclitaxel Injection
intravenous infusion.
Carboplatin Injection
intravenous infusion.
Interventions
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LBL-024 for Injection
intravenous infusion.
Docetaxel Injection
intravenous infusion.
Bevacizumab Injection
intravenous infusion.
Pemetrexed Disodium for Injection
intravenous infusion.
Paclitaxel Injection
intravenous infusion.
Carboplatin Injection
intravenous infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age 18-75 years (inclusive of boundaries) at the time of signing informed consent form.
3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1.
4. The expected survival time is at least 12 weeks.
5. According to the evaluation of RECIST 1.1 standard, the subjects enrolled have at least one measurable lesion.
6. There is adequate organ and bone marrow function,Conforms to laboratory test results.
7. Males with fertility and females of childbearing age are willing to take effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug (including abstinence, intrauterine device, various hormonal contraception, correct use of contraception Sets，etc）; Women of childbearing age include pre-menopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test within 7 days before the first trial drug is administered.
Exclusion Criteria
2. Use of immunomodulatory drugs within 2 weeks before the first use of study drug,Including but not limited to thymopeptide, interleukins, interferon, etc.
3. Patients with active infection.
4. Patients with clinically uncontrollable pleural effusion, pericardial effusion, ascites, and those requiring repeated drainage or medical intervention.
5. The patient has a Medical history of immunodeficiency, including HIV antibody positive.
6. Active hepatitis B or active hepatitis C.
7. Women during pregnancy or lactation.
8. History of mental illness (interfering with understanding or giving informed consent), drug abuse, alcoholism or drug addiction.
9. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Nanjing Leads Biolabs Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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li Zhang
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Chest Hospital，Capital Medical University
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, China
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Ganzhou People's Hospital
Ganzhou, Jiangxi, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
Shandong Cancer Hospital
Jinan, Shandong, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Mianyang Central Hospital
Mianyang, Sichuan, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LBL-024-CN004_01(NSCLC)
Identifier Type: -
Identifier Source: org_study_id
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