A Trial of LBL-024 Combined With Platinum-based Chemotherapy for the Treatment of Advanced EP-NEC
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanjing Leads Biolabs Co.,Ltd
About this trial
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
Qualifiers
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.
Age ≥ 18 years (inclusive) at the time of signing informed consent.
The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~1.
expected survival time of at least 12 weeks.
Disqualifiers
Diagnosed with Mixed neuroendocrine-non endocrine neoplasm (MiNENs).
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.
Use of immunomodulatory drugs within 14 days before the first use of study drug,Including but not limited to thymopeptide, interleukins, interferon, etc.
Patients with active infection requiring intravenous anti-infective therapy within 2 weeks prior to the first dose of study drug.
Trial design
Treatments tested in this trial
- LBL-024 for Injection
- Etoposide injection
- Cisplatin injection
- Carboplatin injection
- LBL-024 placebo for injection
Treatment groups
280 Participants
are divided into 2 treatment groupsSponsors and collaborators
Nanjing Leads Biolabs Co.,Ltd
Lead sponsor
Peking University Cancer Hospital & Institute
Collaborator
Source ClinicalTrials.gov