About this trial
Currently, there are no standard treatment and relevant exploration for NSCLC patients with NED. The study aims to explore the efficacy and safety of surufatinib combined with tislelizumab in the treatment of NSCLC with NED, in order to provide a new treatment option for NSCLC patients with NED.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histopathologically confirmed locally advanced or metastatic unresectable lung cancer (IIIB-IV) with an abnormal NED or NE phenotype (without neuroendocrine morphologic features and positive immunohistochemical expression of at least one neuroendocrine marker (CD56, CgA, Syn));
Have at least one measurable lesion according to RECIST v1.1;
ECOG performance status: 0-1;
Patients who were deemed by the investigator to be eligible for first-line single-agent immunotherapy or who progressed on first-line standard therapy;
Disqualifiers
Pulmonary neuroendocrine tumors (typical carcinoid, atypical carcinoid, small cell carcinoma, large cell neuroendocrine carcinoma);
Prior anti-VEGF/VEGFR-targeted therapy or anti-PD (L)1 antibody;
Have uncontrolled hypertension, defined as systolic blood pressure >150 mmHg or diastolic blood pressure >90 mm Hg, while under anti-hypertension treatment;
Patients with active ulcer, intestinal perforation and intestinal obstruction;
Trial design
Single group
Treatments tested in this trial
Surufatinib
Drug250 mg, po, qd, q3w
Tislelizumab
Drug200mg, iv, q3w
Treatment groups
Trial outcomes
Primary outcomes
Progression-Free Survival (PFS)
time from first-dose to the first documented disease progression or death
Secondary outcomes
Objective response rate (ORR)
the proportion of patients with complete response or partial response, using RESIST v1.1
Disease Control Rate (DCR)
the proportion of patients with complete response, partial response or stable disease, using RESIST v1.1
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: