Recruiting

Surufatinib and Tislelizumab for Advanced Non-Small Cell Lung Cancer

What is being tested

Surufatinib

+ Tislelizumab

+ Concurrent Chemotherapy

DrugRadiation

Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

From 18 to 75 Years

+28 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: July 2025

See protocol details

Summary

Principal SponsorSun Yat-sen University

Study ContactBo QiuMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 20, 2025

Actual date on which the first participant was enrolled.

This study aims to explore the effectiveness of combining two drugs, surufatinib and tislelizumab, with chemoradiotherapy in treating patients with a specific type of lung cancer called locally advanced non-small cell lung cancer. This type of cancer is challenging to treat, and new approaches are needed to improve patient outcomes. By combining these treatments, researchers hope to enhance the effectiveness of traditional chemoradiotherapy and offer better options for patients with this condition. Participants in the study will start by receiving chemoradiotherapy together with surufatinib and tislelizumab. Surufatinib is taken by mouth daily for two weeks, followed by a one-week break, while tislelizumab is given as an infusion every three weeks. If participants show positive responses to this initial treatment, they will continue with the same drugs as a follow-up treatment. The study will monitor how well the cancer responds to this treatment combination, with the goal of extending the time patients stay in remission. This study will also evaluate the safety and any side effects associated with the treatment.

Official TitleEvaluating the Combination of Concurrent Chemoradiotherapy With Surufatinib and Tislelizumab in Patients With Locally Advanced Non-Small Cell Lung Cancer: A Prospective, Single-Arm Phase II Clinical Trial

NCT07086456

Principal SponsorSun Yat-sen University

Study ContactBo QiuMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

Criteria

12 inclusion criteria required to participate

A written and dated informed consent form must be obtained prior to the initiation of any study-specific procedures.

Male or female patients aged 18 to 75 years.

Histologically or cytologically confirmed locally advanced, unresectable non-small cell lung cancer (NSCLC) (Stage IIIA-IIIC).

Tumor sample requirement: Adequate archival, unstained tumor tissue samples must be provided for analysis.

Show More Criteria

16 exclusion criteria prevent from participating

History of autoimmune disease or active autoimmune disease within the past 2 years.

Participation in another clinical study, unless it is an observational (non-interventional) study.

Histological diagnosis of combined small cell and non-small cell lung cancer.

Presence of EGFR or ALK driver gene mutations.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

In this study, all enrolled patients will initially receive definitive concurrent chemoradiotherapy combined with surufatinib and tislelizumab. Patients who achieve complete response (CR), partial response (PR), or stable disease (SD) following the aforementioned treatment will proceed to receive consolidation therapy with surufatinib and tislelizumab. Surufatinib will be administered orally at a dose of 200 mg once daily (QD) for 2 consecutive weeks followed by a 1-week break, with each cycle lasting 3 weeks (21 days). Concurrently, tislelizumab will be administered intravenously at 200 mg every 3 weeks (Q3W), for up to a maximum duration of 12 months.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Sun yat-sen University Cancer Center

Guangzhou, ChinaOpen Sun yat-sen University Cancer Center in Google Maps

Recruiting

One Study Center