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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: NSCLC
• Intervention / Treatment: Drug: Surufatinib; Drug: Tislelizumab

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.

• Study Type: Interventional
• Enrollment (Estimated): 29
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Puyuan Xing, Doctorate; Phone Number: +86-10-87787421; Email: xingpuyuan@cicams.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surufatinib + tislelizumab	Drug: Surufatinib; 250 mg, po, qd, q3w; Drug: Tislelizumab; 200mg, iv, q3w

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	time from first-dose to the first documented disease progression or death	approximately 1 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	the proportion of patients with complete response or partial response, using RESIST v1.1	approximately 1 years
Disease Control Rate (DCR)	the proportion of patients with complete response, partial response or stable disease, using RESIST v1.1	approximately 1 years

Collaborators and Investigators

• Sponsor: National Cancer Center, China
• Investigators: Principal Investigator: Puyuan Xing, Doctorate, Department of Medical Oncology, National Cancer Center, China

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: May 10, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: NSCLC; Surufatinib; Tislelizumab; neuroendocrine differentiation
• Additional Relevant MeSH Terms: Antineoplastic Agents; Antineoplastic Agents, Immunological; Tislelizumab
• Other Study ID Numbers: HMPL-012-SPRING-NEN110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No