A Study Evaluating Neoadjuvant Chemotherapy, Concurrent Chemoradiotherapy Combined With Dual Immune Checkpoint Blockade in Patients With Locally Advanced Non-Small Cell Lung Cancer

Recruiting now · Phase 2

Conditions studied: Lung Cancer (NSCLC)

In brief

This study will enroll patients with locally advanced non-small cell lung cancer (NSCLC). Patients will receive neoadjuvant chemotherapy combined with dual immune checkpoint blockade (PD-1/CTLA-4), bevacizumab and thymosin alpha 1, followed by concurrent chemoradiotherapy, and finally consolidation therapy with dual immune checkpoint blockade (PD-1/CTLA-4), surufatinib and thymosin alpha 1. The study aims to evaluate the efficacy and safety of this treatment regimen.

Key facts

Study ID

NCT07103395

Run by

Sun Yat-sen University

People needed

56

Starts

2026-01-01

Expected to finish

2029-12-30

Last updated by the study team

2026-01-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females aged 18 to 75 years or older;
• Patients must have histologically or cytologically confirmed locally advanced, unresectable (Stage III) non-small cell lung cancer (NSCLC);
• EGFR, ALK, and ROS1 wild-type;
• No prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy;
• Expected survival ≥ 12 weeks;
• WHO Performance Status (PS) score of 0 or 1;
• Female subjects must not be breastfeeding;
• Women of childbearing potential (WOCBP) must agree to use contraception during the study treatment and for 5 months after the last dose of study drug (i.e., 30 days [one ovulation cycle] plus approximately five half-lives of the study drug);
• Adequate organ and bone marrow function as defined by the following criteria:
• Forced Expiratory Volume in 1 second (FEV1) ≥ 800 mL;
• Absolute neutrophil count ≥ 1.5 × 10⁹/L;
• Platelets ≥ 100 × 10⁹/L;
• Hemoglobin ≥ 9.0 g/dL;
• Creatinine clearance ≥ 50 mL/min as calculated by the Cockcroft-Gault formula (Cockcroft and Gault, 1976);
• Serum bilirubin ≤ 1.5 × upper limit of normal (ULN);
• AST and ALT ≤ 2.5 × ULN.

You may not qualify if…

• Exclusion criteria for enrolment for neoadjuvant therapy. Patients should not enter the study if any of the following exclusion criteria are fulfilled:
• Concurrent enrolment in another clinical study, unless it is an observational(non-interventional) clinical study;
• Mixed small cell and non-small cell lung cancer histology;
• Prior use of anti-PD-1, anti-PD-L1, or anti-CTLA4 antibodies;
• Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access;
• Active or prior documented autoimmune disease within the past 2 years;
• Active or prior documented inflammatory bowel disease (eg. Crohn's disease, ulcerative colitis);
• History of primary immunodeficiency;
• History of organ transplant that requires therapeutic immunosuppression;
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent;
• Known history of tuberculosis;
• History of another primary malignancy within 5 years prior to starting treatment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study;
• Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control.
• Exclusion criteria for concurrent chemoradiation following neoadjuvant therapy. Patients should not enter the concurrent chemoradiation phase if any of the following exclusion criteria are fulfilled:
• Patients who develop distant metastasis;
• Patients who develop locoregional disease progression and the irradiation dose of normal tissue will exceed the limit.
• World Health Organization (WHO) Performance Status of 2-4;
• Inadequate organ and marrow function as defined below:
• Forced expiratory volume in 1 second (FEV1) <800ml
• Absolute neutrophil count <1.5 x 109/L (1500 per mm3)
• Platelets <100 x 109/L (100,000 per mm3)
• Haemoglobin<9.0 g/dL (5.59 mmol/L)
• Serum creatinine CL <50 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976)
• Serum bilirubin >1.5 x upper limit of normal (ULN).
• Aspartate Transaminase(AST) and Alanine Transaminase(ALT) >2.5 x ULN.

Where it is running

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.