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NCT07720193
A Trial of LBL-024 Combined With Platinum-based Chemotherapy for the Treatment of Advanced EP-NEC
Conditions: Advanced Extrapulmonary Neuroendocrine Carcinoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 280
Sponsor: Nanjing Leads Biolabs Co.,Ltd
Location: Beijing GoBroad Hospital Beijing Beijing Municipality
Summary
This trial is a randomized, double-blind, placebo-controlled multicenter phase III clinical study aiming to evaluate the efficacy and safety of LBL-024 compared with placebo in combination with etoposide and cisplatin or carboplatin (EP or EC) for the first-line treatment of advanced EP-NEC patients.
Eligibility Criteria
Inclusion Criteria:
1. Agrees to follow the investigational treatment protocol, visit schedule and laboratory test, comply with other requirements of the protocol, voluntarily enroll, and sign a written informed consent.
2. Age ≥ 18 years (inclusive) at the time of signing informed consent.
3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1.
4. expected survival time of at least 12 weeks.
5. According to RECIST 1.1, participants were required to have at least one measurable lesion.
6. Male of childbearing potential and Females of childbearing age are willing to take highly effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug.
Exclusion Criteria:
1. Diagnosed with Mixed neuroendocrine-non endocrine neoplasm (MiNENs).
2. Major surgery (other than aspiration biopsy) within 28 days prior to the first dose of study drug or significant trauma,or required to undergo scheduled surgery during the trial.
3. Use of immunomodulatory drugs within 14 days before the first use of study drug,Including but not limited to thymopeptide, interleukins, interferon, etc.
4. Patients with active infection requiring intravenous anti-infective therapy within 2 weeks prior to the first dose of study drug.
5. serious cardiac and cerebrovascular disorder.
6. History of immunodeficiency including HIV antibody test positive.
7. patients with active hepatitis B or C.
8. Women during pregnancy or lactation.
9. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.
Source: ClinicalTrials.gov (NCT07720193). StuddyBuddy aggregates publicly available trial information.