Maintenance Lurbinectedin in Combination With Serplulimab for Patients With ES-SCLC
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
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
Treatments tested in this trial
- Serplulimab
- Lurbinectedin
- Carboplatin
- Etoposide
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov