A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours[Substudy 01(NSCLC)]
- 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.
- Short title
- A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours[Substudy 01(NSCLC)]
- Official title
- 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)]
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2026-12-24
- First posted
- 2025-01-20
- Registry last updated
- 2026-08-27
- Primary completion date
- 2026-12-24
- Start date
- 2025-06-11
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Nanjing Leads Biolabs Co.,Ltd
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06783647
- ClinicalTrials.gov ID
- NCT06783647
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Objective Response Rate (ORR)
Timeframe: 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)
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.
Disease Control Rate(DCR）
Timeframe: 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)
Percentage of participants achieving CR and PR and stable disease (SD).
Duration of Response(DOR）
Timeframe: 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)
The period from the participants first achieving CR or PR to disease progression.
Cmax
Timeframe: 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)
Maximum drug concentration in plasma after administration
Tmax
Timeframe: 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)
After administration,Time to reach maximum drug concentration in plasma
immunogenicity
Timeframe: 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)
The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- 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.
- 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.
- Anhui Provincial Cancer HospitalHefei, ChinaRecruiting
- Beijing Cancer HospitalBeijing, ChinaRecruiting
- Beijing Chest Hospital，Capital Medical UniversityBeijing, ChinaRecruiting
- Fujian Cancer HospitalFuzhou, ChinaRecruiting
- The First Affiliated Hospital of Xiamen UniversityXiamen, ChinaRecruiting
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaRecruiting
- The First Affiliated Hospital of Guangdong Pharmaceutical UniversityGuangzhou, ChinaRecruiting
- Affiliated Hospital of Guilin Medical UniversityGuilin, ChinaRecruiting
- Guangxi Medical University Cancer HospitalNanning, ChinaRecruiting
- Harbin Medical University Cancer HospitalHarbin, ChinaRecruiting
- The First Affiliated Hospital of Henan University of Science & TechnologyLuoyang, ChinaRecruiting
- Henan Cancer HospitalZhengzhou, ChinaRecruiting
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaRecruiting
- Xiangyang Central HospitalXiangyang, ChinaRecruiting
- The Second Xiangya Hospital of Central South UniversityChangsha, ChinaRecruiting
- Ganzhou People's HospitalGanzhou, ChinaRecruiting
- Jiangxi Cancer HospitalNanchang, ChinaRecruiting
- Liaoning Cancer Hospital and InstituteShenyang, ChinaRecruiting
- Shandong Cancer HospitalJinan, ChinaRecruiting
- First Hospital of Shanxi Medical UniversityTaiyuan, ChinaRecruiting
- Sichuan Provincial People's HospitalChengdu, ChinaRecruiting
- Mianyang Central HospitalMianyang, ChinaRecruiting
- Zhejiang Cancer HospitalHangzhou, ChinaRecruiting
- Taizhou Hospital of Zhejiang ProvinceTaizhou, ChinaRecruiting
Related records
Drugs (5)
Collaborators (1)
- Sun Yat-Sen University Cancer Center