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A Trial of LBL-024 Combined With Platinum-based Chemotherapy for the Treatment of Advanced EP-NEC

ConditionAdvanced Extrapulmonary Neuroendocrine Carcinoma
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • LBL-024 for Injection

    Drug

    Intravenous infusion

  • Etoposide injection

    Drug

    Intravenous infusion

  • Cisplatin injection

    Drug

    Intravenous infusion

  • Carboplatin injection

    Drug

    Intravenous infusion

  • LBL-024 placebo for injection

    Drug

    Intravenous infusion

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: LBL-024 + Etoposide + Cisplatin/carboplatinExperimental treatment 4 interventions
Group B: LBL-024 placebo+ Etoposide + Cisplatin/carboplatinActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

Overall survival (OS)

Time from randomization to death for any reason in a clinical trial.

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)

Secondary outcomes

1

Objective Response Rate (ORR)

Objective Response Rate (complete response (CR) + partial response (PR)), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1), refers to the percentage of study subjects who achieve a complete response or partial response.

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

Disease Control Rate(DCR）

Percentage of participants achieving complete response (CR) or partial response (PR) and stable disease (SD) after treatment.

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

Duration of Response(DOR）

DoR (per RECIST 1.1) is defined as the time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.

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

Progression-free Survival(PFS)

According to the evaluation criteria of RECIST V1.1 (solid tumour),Time from first dose to disease progression or death from any cause.It was used to evaluate Time of disease no-progression or Drug resistance .

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

Peking University Cancer Hospital & Institute

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: