A Clinical Trial of LBL-024 Combined With Etoposide and Platinum in Patients With 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)
Nanjing Leads Biolabs Co.,Ltd
178 participants
Dec 8, 2023
INTERVENTIONAL
Conditions
Summary
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)
Eligibility
Inclusion Criteria6
- Agree to follow the trial treatment regimen and visit schedule, voluntarily enroll, and sign the written informed consent.
- aged 18-75 years (including borderline values) at the time of signing the informed consent form
- The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~1.
- The expected survival time is at least 12 weeks.
- According to the evaluation of RECIST 1.1 （Response Evaluation Criteria in Solid Tumours），the subjects enrolled have at least one measurable target lesion.
- 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 Criteria7
- 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
- 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
- Subjects with an active infection that currently requires intravenous anti-infective therapy.
- Clinically uncontrollable pleural effusion, pericardial effusion, and requiring repeated drainage or medical intervention.
- medical history of immunodeficiency including HIV antibody positive.
- Pregnant or lactating women.
- The investigator believes that the subject has other conditions that may affect compliance or that are not suitable for participating in this study.
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Interventions
intravenous infusion
intravenous infusion
intravenous infusion
intravenous infusion
intravenous infusion
Locations(25)
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NCT06157827