A Clinical Trial of LBL-024 Combined With Etoposide and Platinum in Patients With Advanced Neuroendocrine Carcinoma

Launched by NANJING LEADS BIOLABS CO.,LTD · Nov 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called LBL-024, which is being tested in combination with two other drugs, etoposide and platinum, for patients with advanced neuroendocrine carcinoma (NEC). This trial aims to find out how safe and effective this combination of treatments is for people who are starting treatment for NEC. The trial is currently looking for participants aged 18 to 75 who have a measurable tumor, are generally healthy, and have a life expectancy of at least 12 weeks.

Participants in this trial can expect to receive the study medication and go through regular check-ups to monitor their health and the effects of the treatment. It's important for eligible participants to be willing to use contraception if they can become pregnant or father a child during the study. Additionally, certain individuals, such as those who have had recent major surgery or are pregnant, may not qualify for this trial. Overall, this study offers a potential new option for patients dealing with advanced NEC, and it helps researchers understand how to improve treatment for this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject has voluntarily agreed to participate by giving written informed consent for the trial，and Consent to follow trial treatment and visit schedule
• • 2. aged 18-75 years (including borderline values) at the time of signing the informed consent form
• • 3. Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale
• • 4. Have a life expectancy of at least 12 weeks
• • 5. Subject has at least one measurable target lesion by RECIST 1.1 criteria
• • 6. Fertile men and women of childbearing age are willing to take effective contraceptive measures (including abstinence, intrauterine devices, hormonal contraception, and correct use of condoms) 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. Systemic use of corticosteroidsor other immunosuppressants within 14 days prior to the initial use of the investigational drug;The following conditions are excluded: Treatment with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term use of glucocorticoids for preventive therapy (e.g., to prevent contrast allergy)
• • 4. Subjects with an active infection that currently requires intravenous anti infective therapy
• • 5. History of immunodeficiency, including positive HIV antibody test results
• • 6. Pregnant or lactating women
• • 7. The investigator's assessment that there may be other factors affecting compliance among participants or that some may not be suitable for inclusion in this study.