Surufatinib Combined With Tislelizumab in Advanced Lung Cancer With Neuroendocrine Differentiation

NCT06414915 | Not Yet Recruiting Phase 2

• 1 other identifier: HMPL-012-SPRING-NEN110
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

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.

Conditions

NSCLC

Keywords

NSCLC; neuroendocrine differentiation; Surufatinib; Tislelizumab

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

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

  approximately 1 years

Secondary Outcomes (2)

• Objective response rate (ORR)

  approximately 1 years

• Disease Control Rate (DCR)

  approximately 1 years

Study Arms (1)

Surufatinib + tislelizumab

EXPERIMENTAL

Drug: Surufatinib; Drug: Tislelizumab

Interventions

Surufatinib DRUG

250 mg, po, qd, q3w

Surufatinib + tislelizumab

Tislelizumab DRUG

200mg, iv, q3w

Surufatinib + tislelizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Center, China: lead

MeSH Terms

Interventions

surufatinib; tislelizumab

Study Officials

• Puyuan Xing, Doctorate

  Department of Medical Oncology, National Cancer Center, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Puyuan Xing, Doctorate

CONTACT

+86-10-87787421; xingpuyuan@cicams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Medical Officer

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 16, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share