A Study on the First-line Treatment of Small Cell Lung Cancer With Adebrelimab and Vunakizumab and Chemotherapy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFujian Cancer Hospital
About this trial
This study is a prospective, single-center, single-arm clinical trial, with a planned enrollment of 28 cases.The first Adebrelimab +Vunakizumab +EC was administered within 72 hours after enrollment for 4 to 6 cycles.At the end of the combination phase, non-PD subjects entered the maintenance treatment period of Adebrelimab plus Vunakizumab.Treatment will continue until any of the following situations occur: disease progression in the subject, intolerable toxic and side effects, comorbidiments that affect further treatment, the investigator's decision to withdraw the subject from the study, or other reasons for non-compliance with the study treatment or the study procedures or protocols.
Eligibility criteria
Qualifiers
1. Age: 18 to 75 years old, both male and female are acceptable.
2. Histologically or cytologically confirmed extensive-stage small cell Lung cancer (according to the Veterans Administration Lung Study Group, VALG staging);
3. No previous systematic treatment;
4. Life expectancy exceeds 3 months;
Disqualifiers
1. There is a large amount of uncontrolled pleural effusion, pericardial effusion or ascites;
2. The following heart disorders exist: (1) According to NYHA cardiac function classification, (1) Grade III-IV cardiac function; (2) Unstable angina pectoris or acute ischemia indicated by electrocardiogram or myocardial infarction occurred within one year; (3) Clinically significant supraventricular or ventricular arrhythmias and other conduction system abnormalities (including QTc interval ≥ 450ms in men and ≥470ms in women); (4) Clinically significant pericardial and myocardial diseases.
3. Insufficient bone marrow reserve or organ function;
4. Systemic immunomodulators (including but not limited to thymosin, interferon or interleukin-2) have been used for treatment within 4 weeks before enrollment;
Trial design
Treatments tested in this trial
- Vunakizumab (IL-17A inhibitor)
- Adebrelimab
- Chemotherapy
Treatment groups
28 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov