## Protocol Section
### Identification Module
**NCT ID:** NCT06414915

**Brief Title:** Surufatinib Combined With Tislelizumab in Advanced Lung Cancer With Neuroendocrine Differentiation

**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

#### Organization Study ID Info
**ID:** HMPL-012-SPRING-NEN110
#### Organization
**Class:** OTHER
**Full Name:** National Cancer Center, China
### Status Module
#### Completion Date
**Date:** 2027-06-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-06-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** National Cancer Center, China

#### Responsible Party

**Investigator Affiliation:** National Cancer Center, China

**Investigator Full Name:** Puyuan Xing

**Investigator Title:** Chief Medical Officer

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- NSCLC

**Keywords:**

- NSCLC

- neuroendocrine differentiation

- Surufatinib

- Tislelizumab

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 29

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Surufatinib

- Drug: Tislelizumab

**Label:** Surufatinib + tislelizumab

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Surufatinib + tislelizumab

**Description:** 250 mg, po, qd, q3w

**Name:** Surufatinib

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Surufatinib + tislelizumab

**Description:** 200mg, iv, q3w

**Name:** Tislelizumab

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Progression-Free Survival (PFS)

**Time Frame:** approximately 1 years

#### Secondary Outcomes

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

**Measure:** Objective response rate (ORR)

**Time Frame:** approximately 1 years

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

**Measure:** Disease Control Rate (DCR)

**Time Frame:** approximately 1 years

### Eligibility Module

**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.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** xingpuyuan@cicams.ac.cn

**Name:** Puyuan Xing, Doctorate

**Phone:** +86-10-87787421

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Department of Medical Oncology, National Cancer Center, China

**Name:** Puyuan Xing, Doctorate

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M11172

- Name: Lung Neoplasms

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M137899

- Name: Tislelizumab

- Relevance: HIGH

- As Found: Meet

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000707970

- Term: Tislelizumab

### Misc Info Module

- Version Holder: 2024-05-31
