Combining LBL-024 with Etoposide and Platinum for Advanced Neuroendocrine Carcinoma

An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of LBL-024 Combined With Etoposide and Platinum in the First-line Treatment of Patients With Advanced Neuroendocrine Carcinoma (NEC)

This study is testing if a new drug called LBL-024, when combined with standard chemotherapy, can help people with advanced neuroendocrine carcinoma who haven't had treatment before.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 178 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Nanjing Leads Biolabs Co.,Ltd (Industry-sponsored)
• Locations: 25 sites (Hefei, Anhui and 24 other locations)
• Trial ID: NCT06157827 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of LBL-024 in combination with etoposide and platinum-based chemotherapy in patients with advanced neuroendocrine carcinoma. It consists of two phases: Phase Ib focuses on dose-escalation to determine safety and tolerability, while Phase II aims to optimize the dose and expand the study to gather efficacy data. The trial will enroll a total of 178 patients who have not previously received systemic therapy for their condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with advanced neuroendocrine carcinoma who have not received prior systemic therapy.

Not a fit: Patients with a performance status greater than 1 or those who have received prior systemic treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced neuroendocrine carcinoma.

How similar studies have performed: While this approach is novel, similar studies combining targeted therapies with chemotherapy have shown promise in other cancer types.

Eligibility criteria

Inclusion Criteria:

1. Agree to follow the trial treatment regimen and visit schedule, voluntarily enroll, and sign the written informed consent.
2. aged 18-75 years (including borderline values) at the time of signing the 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 （Response Evaluation Criteria in Solid Tumours），the subjects enrolled have at least one measurable target lesion.
6. Fertile men and women of childbearing age are willing to take effective contraceptive measures from the signing of the informed consent form to 6 months after the last dose of the investigational drug; women of childbearing age include premenopausal women and women who had menopause less than two years ago. Blood pregnancy test results must be negative for women of childbearing age within 7 days prior to the initial dose of the investigational drug.

Exclusion Criteria:

1. Subjects who underwent major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the initial use of the investigational drug, or require elective surgery during the trial period
2. Use of immunomodulatory drugs within 14 days prior to the initial use of the investigational drug, including but not limited to thymosin, interleukin, and interferon
3. Subjects with an active infection that currently requires intravenous anti-infective therapy.
4. Clinically uncontrollable pleural effusion, pericardial effusion, and requiring repeated drainage or medical intervention.
5. medical history of immunodeficiency including HIV antibody positive.
6. Pregnant or lactating women.
7. The investigator believes that the subject has other conditions that may affect compliance or that are not suitable for participating in this study.

Where this trial is running

Hefei, Anhui and 24 other locations

• Anhui Provincial Hospital — Hefei, Anhui, China (Recruiting)
• Anhui Cancer Hospital — Hefei, Anhui, China (Recruiting)
• Beijing GoBroad Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Chongqing University Cancer Hospital — Chongqing, Chongqing Municipality, China (Recruiting)
• Fujian Cancer Hospital — Fuzhou, Fujian, China (Recruiting)
• Sun Yat-sen University Cancer Center (SYSUCC) — Guangzhou, Guangdong, China (Recruiting)
• The First Affiliated Hospital of Guangdong Pharmaceutical University — Guangzhou, Guangdong, 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 and Technology — Luoyang, Henan, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• Hubei Cancer Hospital — Wuhan, Hubei, China (Recruiting)
• Xiangyang Central Hospital — Xiangyang, Hubei, China (Recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• Liaoning Cancer Hospital — Shenyang, Liaoning, China (Recruiting)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
• Shandong Cancer Hospital — Jinan, Shandong, China (Recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
• Shanxi Cancer hospital — Taiyuan, Shanxi, China (Recruiting)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)
• The First Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• The Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• Sir Run Run Shaw Hospital，Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: lin shen — Peking University Cancer Hospital & Institute
• Study coordinator: lin shen

Conditions Advanced Neuroendocrine Carcinoma