A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours[Substudy 01(NSCLC)]

May 15, 2026 updated by: Nanjing Leads Biolabs Co.,Ltd

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)]

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This trial is an open-label, multicenter, phase II clinical study of LBL-024 combination therapy in patients with advanced NSCLC, to evaluate the efficacy and safety of LBL-024 combination therapy .The trial includes 4 cohorts.

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.

Study Type

Interventional

Enrollment (Estimated)

230

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230031
        • Recruiting
        • Anhui Provincial Cancer Hospital
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
      • Beijing, Beijing Municipality, China, 101100
        • Recruiting
        • Beijing Chest Hospital,Capital Medical University
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350014
      • Xiamen, Fujian, China, 361102
        • Recruiting
        • The first affiliated hospital of xiamen university
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
      • Guangzhou, Guangdong, China, 510062
        • Recruiting
        • The First Affiliated Hospital of Guangdong Pharmaceutical University
        • Contact:
    • Guangxi
      • Guilin, Guangxi, China, 541001
        • Recruiting
        • Affiliated Hospital of Guilin Medical University
        • Contact:
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • Guangxi Medical University Cancer Hospital
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
    • Henan
      • Luoyang, Henan, China, 471023
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science & Technology
        • Contact:
      • Zhengzhou, Henan, China, 450003
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
      • Xiangyang, Hubei, China, 441106
    • Hunan
      • Changsha, Hunan, China, 410011
        • Recruiting
        • The second Xiangya hospital of central south university
        • Contact:
    • Jiangxi
      • Ganzhou, Jiangxi, China, 341006
      • Nanchang, Jiangxi, China, 330029
    • Liaoning
      • Shenyang, Liaoning, China, 110167
    • Shandong
      • Jinan, Shandong, China, 250117
    • Shanxi
      • Taiyuan, Shanxi, China, 030012
        • Recruiting
        • First Hospital of Shanxi Medical University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
      • Mianyang, Sichuan, China, 621000
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
      • Taizhou, Zhejiang, China, 317000
        • Recruiting
        • Taizhou Hospital of Zhejiang Province
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: LBL-024 for Injection
intravenous infusion.
Other Names:
  • LBL-024
Drug: Docetaxel Injection
intravenous infusion.
Other Names:
  • Docetaxel
Drug: Bevacizumab Injection
intravenous infusion.
Other Names:
  • Bevacizumab
Experimental: LBL-024+Docetaxel

Cohort 1 B：

Subjects were treated with LBL-024 combined with docetaxel,

Intravenous infusion.
Drug: LBL-024 for Injection
intravenous infusion.
Other Names:
  • LBL-024
Drug: Docetaxel Injection
intravenous infusion.
Other Names:
  • Docetaxel
Experimental: 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.
Drug: LBL-024 for Injection
intravenous infusion.
Other Names:
  • LBL-024
Drug: Pemetrexed Disodium for Injection
intravenous infusion.
Other Names:
  • Pemetrexed Disodium
Drug: Carboplatin Injection
intravenous infusion.
Other Names:
  • Carboplatin
Experimental: 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.
Drug: LBL-024 for Injection
intravenous infusion.
Other Names:
  • LBL-024
Drug: Carboplatin Injection
intravenous infusion.
Other Names:
  • Carboplatin
Drug: Paclitaxel Injection
intravenous infusion.
Other Names:
  • Paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Control Rate(DCR）
Time Frame: 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).
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）
Time Frame: 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.
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Leads Biolabs Co.,Ltd

Collaborators

Sun Yat-Sen University Cancer Center

Investigators

  • Principal Investigator: li Zhang, Sun Yat-sen University Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2025

Primary Completion (Estimated)

December 24, 2026

Study Completion (Estimated)

December 24, 2026

Study Registration Dates

First Submitted

January 14, 2025

First Submitted That Met QC Criteria

January 14, 2025

First Posted (Actual)

January 20, 2025

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LBL-024-CN004_01(NSCLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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