Surufatinib Combined With Tislelizumab in Advanced Lung Cancer With Neuroendocrine Differentiation

NCT ID: NCT06414915

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2027-06-01

Brief 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.

Conditions

NSCLC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surufatinib + tislelizumab

Group Type: EXPERIMENTAL

Surufatinib

Intervention Type: DRUG

250 mg, po, qd, q3w

Tislelizumab

Intervention Type: DRUG

200mg, iv, q3w

Interventions

Surufatinib

250 mg, po, qd, q3w

Intervention Type: DRUG

Tislelizumab

200mg, iv, q3w

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Center, China

OTHER

Sponsor Role: lead

Responsible Party

Puyuan Xing

Chief Medical Officer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Puyuan Xing, Doctorate

Role: PRINCIPAL_INVESTIGATOR

Department of Medical Oncology, National Cancer Center, China

Central Contacts

Puyuan Xing, Doctorate

Role: CONTACT

xingpuyuan@cicams.ac.cn

+86-10-87787421

Other Identifiers

HMPL-012-SPRING-NEN110

Identifier Type: -

Identifier Source: org_study_id