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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: lin shen — Peking University Cancer Hospital & Institute
• Study coordinator: lin shen
• Email: kongxue@leadsbiolabs.com
• Phone: 025-83378099

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.