Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT06414915

Not yet recruiting

Surufatinib Combined With Tislelizumab in Advanced Lung Cancer With Neuroendocrine Differentiation

Interventional

Phase 2

Sponsor: National Cancer Center, China

Last Updated: May 16, 2024
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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.

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Treatment Category

Drug

Required Mutations

None

Trial Started

June 1, 2024

Last Updated by Sponsor

May 16, 2024

Estimated Completion

June 1, 2026

Contact Study

Name:Puyuan Xing, Doctorate

Email:xingpuyuan@cicams.ac.cn

Phone:+86-10-87787421

Eligibility

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.

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Design Details

AllocationN/A

Intervention ModelSingle Group Assignment

MaskingNone (Open Label)

Number to Enroll29

Arms & Interventions

Arms

Interventions

Type: Experimental

Description:

Interventions:

Surufatinib
Tislelizumab

Outcome Measures

Primary Outcome Measures

Progression-Free Survival (PFS)approximately 1 years

time from first-dose to the first documented disease progression or death

Secondary Outcome Measures

Disease Control Rate (DCR)approximately 1 years

the proportion of patients with complete response, partial response or stable disease, using RESIST v1.1

Objective response rate (ORR)approximately 1 years

the proportion of patients with complete response or partial response, using RESIST v1.1