Surufatinib Combined With Tislelizumab in Advanced Lung Cancer With Neuroendocrine Differentiation

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06414915
• Other study ID #: HMPL-012-SPRING-NEN110
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2024
• Est. completion date: June 1, 2027

Study information

• Verified date: May 2024
• Source: National Cancer Center, China
• Contact: Puyuan Xing, Doctorate
• Phone: +86-10-87787421
• Email: xingpuyuan[@]cicams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 29
• Est. completion date: June 1, 2027
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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.

Related Conditions & MeSH terms

• NSCLC

Intervention

Drug:
• Surufatinib
250 mg, po, qd, q3w
• Tislelizumab
200mg, iv, q3w

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS)	time from first-dose to the first documented disease progression or death	approximately 1 years
Secondary	Objective response rate (ORR)	the proportion of patients with complete response or partial response, using RESIST v1.1	approximately 1 years
Secondary	Disease Control Rate (DCR)	the proportion of patients with complete response, partial response or stable disease, using RESIST v1.1	approximately 1 years