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Trial Title:
Surufatinib Combined With Tislelizumab in Advanced Lung Cancer With Neuroendocrine Differentiation
NCT ID:
NCT06414915
Condition:
NSCLC
Conditions: Official terms:
Tislelizumab
Conditions: Keywords:
NSCLC
neuroendocrine differentiation
Surufatinib
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Surufatinib
Description:
250 mg, po, qd, q3w
Arm group label:
Surufatinib + tislelizumab
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
200mg, iv, q3w
Arm group label:
Surufatinib + tislelizumab
Summary:
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.
Detailed description:
This is a single-arm, open, single-center, prospective and exploratory clinical study. We
planned to enroll 29 patients who would receive surufatinib plus tislelizumab until
disease progression, intolerance, or withdrawal of consent. 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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;
- Urine protein < ++ . If Urine protein ≥ ++ ,the amount of urine protein in 24 hours
≤1.0g;
- Expected survival time > 3 months;
Exclusion Criteria:
- 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;
- With active bleeding or bleeding tendency;
- Severe history of cardiovascular and cerebrovascular diseases;
- Other malignancies diagnosed within the previous 5 years, except basal cell
carcinoma or cervical carcinoma in situ after radical resection.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
June 1, 2024
Completion date:
June 1, 2027
Lead sponsor:
Agency:
National Cancer Center, China
Agency class:
Other
Source:
National Cancer Center, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06414915
