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Maintenance Lurbinectedin in Combination With Serplulimab for Patients With ES-SCLC

ConditionExtensive-Stage Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangzhou Institute of Respiratory Disease

About this trial

This is a single-arm, open-lable exploratory study of Lurbinectedin in combination with Serplulimab as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) after first-line induction therapy with carboplatin, etoposide, and Serplulimab. The study consists of 2 phases: an induction phase and a maintenance phase. Participants need to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria after completion of 4 cycles of carboplatin, etoposide, and Serplulimab induction treatment in order to be considered for eligibility screening for the maintenance phase. Eligible participants will receive lurbinectedin plus Serplulimab in the maintenance phase.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fully informed about the study and voluntarily signed a written informed consent form, and able to comply with the requirements and restrictions listed in the informed consent form;

Male or female with age ≥ 18 years;

Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1;

Histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC) and has not received any systemic treatment for ES-SCLC;

Disqualifiers

Have a history of central nervous system (CNS) metastasis or related history;

Have a history of active autoimmune disease or immunodeficiency, or related history;

Have a history of malignancies other than SCLC within 5 years before enrollment;

Previous treatment with immune checkpoint inhibitors or lurbinectedin;

Trial design

Design model

Single group

Treatments tested in this trial

  • Serplulimab

    Drug

    Serplulimab will be administered intravenously at a dose of 4.5 mg/kg on Day 1 of each 21-day cycle for 4 cycles in the induction phase. Serplulimab will be administered intravenously at a dose of 4.5 mg/kg on Day 1 of each 21-day cycle in the maintenance phase.

  • Lurbinectedin

    Drug

    Lurbinectedin will be administered intravenously at a fixed dose of 4 mg on Day 1 of each 21-day cycle in the maintenance phase.

  • Carboplatin

    Drug

    Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase.

  • Etoposide

    Drug

    Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Experimental TreatmentExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS)

progression-free survival (PFS) is defined as the time from the initiation of maintenance therapy to the date of first documented disease progression (as assessed according to RECIST v1.1) or death whichever occurs first.

Time frame
Initiation of maintenance therapy to the date of first documented disease progression or death whichever occurs first (up to approximately 24 months)

Secondary outcomes

1

Overall Survival (OS)

Overall survival (OS) is defined as the time from the initiation of maintenance therapy to the date of death from any cause.

Time frame
Initiation of maintenance therapy to the date of death from any cause (up to approximately 24 months)
2

Objective Response Rate (ORR)

Objective response rate (ORR) is defined as the proportion of participants with a complete response（CR） or partial response（PR） according to RECIST v1.1.

Time frame
up to approximately 24 months
3

Duration of Response (DOR)

Duration of Response (DOR) (for participants with a confirmed objective response) is defined as the time from the first occurrence of a documented confirmed objective response until disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.

Time frame
up to approximately 24 months
4

Percentage of Participants With Adverse Events

Percentage of participants with adverse events

Time frame
up to approximately 24 months

Other outcomes

Sponsors and contacts

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

Guangzhou Institute of Respiratory Disease

Lead sponsor

Source ClinicalTrials.gov
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