Clinical trial · Interventional
Surufatinib Combined With Tislelizumab in Advanced Lung Cancer With Neuroendocrine Differentiation
A Single-arm, Open, Single-center, Prospective and Exploratory Clinical Study of Surufatinib Combined With Tislelizumab in the Treatment of Advanced Lung Cancer With Neuroendocrine Differentiation
NCT06414915CI-TRIAL-00077219not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surufatinib | Drug | — | UNRESOLVED |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Surufatinib + tislelizumab
- interventionNames
- Drug: Surufatinib
- Drug: Tislelizumab
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- approximately 1 years
- description
- time from first-dose to the first documented disease progression or death
Secondary outcomes (2)
- measure
- Objective response rate (ORR)
- timeFrame
- approximately 1 years
- description
- the proportion of patients with complete response or partial response, using RESIST v1.1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.