> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-clinical-trial-of-lbl-024-combination-drug-in-patients-f9d0822e-2948-4529-85b7-5acc208e525d > Record changed: 2026-11-04 # A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours\[Substudy 01(NSCLC)\] NCT06783647 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) Participants 250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) Lead sponsor Nanjing Leads Biolabs Co.,Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) Start date 2025-06-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) Number of sites 24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) **Short title** A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours\[Substudy 01(NSCLC)\] Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) **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\[Substudy Number 01(NSCLC)\] Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) ## Dates **Completion date** 2026-12-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) **First posted** 2025-01-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) **Registry last updated** 2026-08-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) **Primary completion date** 2026-12-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) **Start date** 2025-06-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) ## Size and sites **Participants** 250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) **Planned participants** 250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) **Number of sites** 24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) **Lead sponsor** Nanjing Leads Biolabs Co.,Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) ## Identifiers **Registry ID** NCT06783647 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) **ClinicalTrials.gov ID** NCT06783647 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) ## Outcomes ### Primary outcomes 1. 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. ### Secondary outcomes 1. 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). 2. 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. 3. 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 4. 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 5. 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria 1. 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. 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 1. 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. 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) ## Sites - 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 Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06783647) ## Related records ### Drugs (5) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Docetaxel](https://trialight.com/data/asset/docetaxel-3c835086-a86f-4a89-abb6-45847fbab5d6.md) - [Paclitaxel](https://trialight.com/data/asset/paclitaxel-889db92c-df97-46a6-bf1c-74974a87fa75.md) - [Pemetrexed disodium](https://trialight.com/data/asset/pemetrexed-disodium-c80fe85f-320e-4817-87cb-0c8bbcbe8967.md) ### Collaborators (1) - Sun Yat-Sen University Cancer Center ### Lead sponsors (1) - [Nanjing Leads Biolabs Co.,Ltd](https://trialight.com/data/company/nanjing-leads-biolabs-co-ltd-dcc320d4-6d8d-4b00-aaec-aafcc1115c44.md) ### Targets (21) - [DHFR](https://trialight.com/data/target/dhfr-e77e5dcd-f4e0-5e26-b456-0a5b230a72b3.md) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) - [GART](https://trialight.com/data/target/gart-01a731ec-9c88-556f-8fc6-2217fab015bc.md) - [NR1I2](https://trialight.com/data/target/nr1i2-40bab506-b45a-5acc-acc5-9834cb940ee5.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) - [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md) - [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) --- ## A note for AI agents You are probably reading this for a person. 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