LBL-024 combination therapy for advanced non-small cell lung cancer (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)]

This study tests whether adding LBL-024 to chemotherapy or other cancer drugs helps people with advanced NSCLC respond better or live longer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 230 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Nanjing Leads Biolabs Co.,Ltd (industry)
• Locations: 24 sites (Hefei, Anhui and 23 other locations)
• Trial ID: NCT06783647 on ClinicalTrials.gov

What this trial studies

This is an open-label, multicenter phase II trial testing LBL-024 given together with standard chemotherapy and targeted agents in patients with advanced NSCLC. The trial is organized into multiple cohorts, each beginning with a small safety run-in and proceeding to expanded enrollment if the combination is tolerable, with one cohort including randomization between two arms. Regimens include LBL-024 combined with agents such as docetaxel, bevacizumab, pemetrexed, and paclitaxel, with maintenance therapy planned in some cohorts. The study’s main outcomes are treatment efficacy (response and disease control) and safety (adverse events and tolerability).

Who should consider this trial

Good fit: Adults aged 18–75 with advanced NSCLC, ECOG performance status 0–1, at least one measurable lesion per RECIST 1.1, and adequate organ and bone marrow function are the intended participants.

Not a fit: Patients with ECOG performance status greater than 1, expected survival under 12 weeks, inadequate organ or bone marrow function, or who cannot attend the listed hospital sites are unlikely to benefit.

Why it matters

Potential benefit: If successful, this combination could improve tumor response rates and extend survival or disease control for patients with advanced NSCLC.

How similar studies have performed: Combining new targeted agents with chemotherapy has produced meaningful benefits in other NSCLC trials, but LBL-024 itself is investigational and not yet proven.

Eligibility criteria

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.

Where this trial is running

Hefei, Anhui and 23 other locations

• Anhui Provincial Cancer Hospital — Hefei, Anhui, China (RECRUITING)
• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• Beijing Chest Hospital，Capital Medical University — Beijing, Beijing Municipality, China (RECRUITING)
• Fujian Cancer Hospital — Fuzhou, Fujian, China (RECRUITING)
• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (RECRUITING)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)
• The First Affiliated Hospital of Guangdong Pharmaceutical University — Guangzhou, Guangdong, China (RECRUITING)
• Affiliated Hospital of Guilin Medical University — Guilin, Guangxi, China (RECRUITING)
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (RECRUITING)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (RECRUITING)
• The First Affiliated Hospital of Henan University of Science & Technology — Luoyang, Henan, China (RECRUITING)
• Henan Cancer Hospital — Zhengzhou, Henan, China (RECRUITING)
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (RECRUITING)
• Xiangyang Central Hospital — Xiangyang, Hubei, China (RECRUITING)
• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (NOT_YET_RECRUITING)
• Ganzhou People's Hospital — Ganzhou, Jiangxi, China (RECRUITING)
• Jiangxi Cancer Hospital — Nanchang, Jiangxi, China (RECRUITING)
• Liaoning Cancer Hospital and Institute — Shenyang, Liaoning, China (RECRUITING)
• Shandong Cancer Hospital — Jinan, Shandong, China (RECRUITING)
• First Hospital of Shanxi Medical University — Taiyuan, Shanxi, China (RECRUITING)
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (RECRUITING)
• Mianyang Central Hospital — Mianyang, Sichuan, China (RECRUITING)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (RECRUITING)
• Taizhou Hospital of Zhejiang Province — Taizhou, Zhejiang, China (RECRUITING)

Study contacts

• Principal investigator: li Zhang — Sun Yat-sen University
• Study coordinator: li Zhang

Conditions: Advanced Solid Tumour