A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours[Substudy 01(NSCLC)]
An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of LBL-024 in Combination With Other Drugs for the Treatment of Patients With Advanced Solid Tumour[Substudy Number 01(NSCLC)]
1 other identifier
interventional
230
1 country
24
Brief Summary
An open-label, multicenter, phase II clinical study to evaluate the efficacy and safety of LBL-024 in combination with other drugs for the treatment of patients with advanced solid tumour.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2025
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2025
CompletedFirst Posted
Study publicly available on registry
January 20, 2025
CompletedStudy Start
First participant enrolled
June 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 24, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 24, 2026
February 12, 2026
January 1, 2026
1.5 years
January 14, 2025
February 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
Objective Response Rate (complete response (CR) + partial response (PR)), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1), refers to the percentage of study subjects who achieve a complete response or partial response.
From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Secondary Outcomes (5)
Disease Control Rate(DCR）
From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Duration of Response(DOR）
From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Cmax
From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Tmax
From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
immunogenicity
From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Study Arms (4)
LBL-024+Docetaxel/LBL-024+Bevacizumab+Docetaxel
EXPERIMENTALCohort 1 A： Subjects were treated with LBL-024 combined with docetaxel or LBL-024 combined with bevacizumab and docetaxel, Intravenous infusion.
LBL-024+Docetaxel
EXPERIMENTALCohort 1 B： Subjects were treated with LBL-024 combined with docetaxel, Intravenous infusion.
LBL-024+Pemetrexed Disodium+Carboplatin/LBL-024+pemetrexed Disodium
EXPERIMENTALCohort 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+Paclitaxel+Carboplatin/LBL-024
EXPERIMENTALCohort 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.
Interventions
intravenous infusion.
intravenous infusion.
intravenous infusion.
intravenous infusion.
intravenous infusion.
intravenous infusion.
Eligibility Criteria
You may qualify if:
- Agree to follow the trial treatment regimen, visit schedule, laboratory test, and other requirements of the protocol, and voluntarily enroll in the study and sign the written informed consent.
- Age 18-75 years (inclusive of boundaries) at the time of signing informed consent form.
- The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1.
- The expected survival time is at least 12 weeks.
- According to the evaluation of RECIST 1.1 standard, the subjects enrolled have at least one measurable lesion.
- There is adequate organ and bone marrow function,Conforms to laboratory test results.
- 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.
You may not qualify if:
- Participation in clinical studies of antineoplastic agents within 4 weeks before the first use of study drug,or Subject is expected to receive any other form of systemic or local anti-tumor therapy outside the protocol during the study.
- Use of immunomodulatory drugs within 2 weeks before the first use of study drug,Including but not limited to thymopeptide, interleukins, interferon, etc.
- Patients with active infection.
- Patients with clinically uncontrollable pleural effusion, pericardial effusion, ascites, and those requiring repeated drainage or medical intervention.
- The patient has a Medical history of immunodeficiency, including HIV antibody positive.
- Active hepatitis B or active hepatitis C.
- Women during pregnancy or lactation.
- History of mental illness (interfering with understanding or giving informed consent), drug abuse, alcoholism or drug addiction.
- The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nanjing Leads Biolabs Co.,Ltdlead
- Sun Yat-sen Universitycollaborator
Study Sites (24)
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230031, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Beijing Chest Hospital，Capital Medical University
Beijing, Beijing Municipality, 101100, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361102, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, 510062, China
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, 541001, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, 471023, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Xiangyang Central Hospital
Xiangyang, Hubei, 441106, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
Ganzhou People's Hospital
Ganzhou, Jiangxi, 341006, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110167, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030012, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
Mianyang Central Hospital
Mianyang, Sichuan, 621000, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 317000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
li Zhang
Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2025
First Posted
January 20, 2025
Study Start
June 11, 2025
Primary Completion (Estimated)
December 24, 2026
Study Completion (Estimated)
December 24, 2026
Last Updated
February 12, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share