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

ConditionAdvanced Neuroendocrine Carcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNanjing Leads Biolabs Co.,Ltd

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • LBL-024 for Injection

    Drug

    intravenous infusion

  • Etoposide Injection

    Drug

    intravenous infusion

  • Carboplatin Injection

    Drug

    intravenous infusion

  • Atezolizumab injection

    Drug

    intravenous infusion

  • Cisplatin injection

    Drug

    intravenous infusion

Treatment groups

178 Participants
are divided into 2 treatment groups
Group A: LBL-024+Etoposide+Carboplatin/CisplatinExperimental treatment 4 interventions
Group B: Atezolizumab+Etoposide+CarboplatinActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

ORR (including the rates of complete response (CR) and partial response (PR)), evaluated based on the RECIST 1.1, refers to the percentage of study subjects who achieve a complete response or partial response. It was used to evaluate the efficacy in Phase II .

Time frame
From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy).
2

Dose-limiting toxicities（DLT）

DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. It was used to evaluate the safety in Phase Ib.

Time frame
Within 3 weeks after receiving the first dose of the test drug (DLT assessment for subjects in dose escalation phase).
3

Progression-Free Survival(PFS)

PFS is defined as the time from randomization to disease progression or death from any cause.It was used to evaluate the efficacy in Phase II .

Time frame
From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy).
4

Occurrence of adverse event (AE) and serious adverse event (SAE)

Adverse event (AE) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0.The safety profile of LBL-024 Combination Administration will be assessed by monitoring the adverse event (AE) and serious adverse event (SAE) in Phase Ib study.

Time frame
From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (90 days after drug withdrawal or before the start of new anti-tumor therapy)

Secondary outcomes

1

Cmax

Maximum serum concentration

Time frame
From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy
2

Tmax

After taking a single dose, Time to reach maximum plasma concentration

Time frame
From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy
3

immunogenicity

The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects

Time frame
From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy
4

Duration of Response(DOR）

The period from the participants first achieving CR or PR to disease progression.

Time frame
From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanjing Leads Biolabs Co.,Ltd

Lead sponsor

Source ClinicalTrials.gov
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