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

January 12, 2026 updated by: Hui Liu, Sun Yat-sen University

A Phase II Study Evaluating Neoadjuvant Chemotherapy, Concurrent Chemoradiotherapy Combined With Dual Immune Checkpoint Blockade (PD-1/CTLA-4) in Patients With Locally Advanced Non-Small Cell Lung Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Sun Yat-Sen University Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  1. 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.

  2. 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.

  3. Further exclusion criteria for consolidation therapy. Patients should not enter the consolidation therapy if any of the following exclusion criteria are fulfilled:

    • Patients who have progressed whilst definitive platinum based, concurrent chemoradiation therapy;
    • Current or prior use of immunosuppressive medication within 28 days before the first dose of Iparomlimab and tuvonralimab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Systemic steroid administration required to manage toxicities arising from radiation therapy delivered as part of the chemoradiation therapy for locally advanced NSCLC is allowed.
    • Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy will be excluded from randomization;
    • Patients with Grade ≥2 pneumonitis from prior chemoradiation therapy will be excluded from randomization;
    • Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE>Grade 1.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The study group
Patients will receive neoadjuvant chemotherapy combined with iparomlimab and tuvonralimab and thymosin alpha 1, followed by concurrent chemoradiotherapy, and finally consolidation therapy with iparomlimab and tuvonralimab and thymosin alpha 1.
Drug: Neoadjuvant therapy
The neoadjuvant regimen prior to radiotherapy consists of albumin-bound paclitaxel/pemetrexed, cisplatin, Bevacizumab, iparomlimab and tuvonralimab, and thymosin alpha 1.
Radiation: Radiotherapy
Definitive dose of hypofractionated radiotherapy was delivered to patients, with concurrent chemotherapy and surufatinib.
Drug: Consolidative therapy
Consolidation therapy consists of iparomlimab and tuvonralimab, surufatinib and thymosin alpha 1, for a total duration of 1 year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 2-year
PFS measures the time from the start date of treatment to disease progression, death from any cause or last follow up if alive.
2-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 2-year
OS measures the time from the start date of treatment to death from any cause or last follow up if alive.
2-year
Treatment-related toxicity
Time Frame: through study completion, an average of 18 months
Treatment-related toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) 5.0 toxicity
through study completion, an average of 18 months
Objective response rate
Time Frame: 2 month after treatment
2 month after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

December 30, 2029

Study Completion (Estimated)

December 30, 2029

Study Registration Dates

First Submitted

July 16, 2025

First Submitted That Met QC Criteria

August 2, 2025

First Posted (Actual)

August 5, 2025

Study Record Updates

Last Update Posted (Estimated)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GASTO-10135

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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