The Impact of Thymosin α-1 on the Efficacy of Concurrent Chemoradiotherapy Followed by Immunotherpay Consolidation for Locally Advanced NSCLC

November 13, 2025 updated by: Hui Liu, Sun Yat-sen University

A Prospective Phase II Controlled Study to Evaluate the Impact of Thymosin Alpha 1 on the Completion Rate of Consolidation Immunotherapy After Radical Radiochemotherapy for Locally Advanced Non-Small Cell Lung Cancer

This prospective phase II randomized study is to determine the impact of thymosin alpha-1 on the concurrent chemoradiotherpay followed by immunotherapy consolidation in patients with locally advanced NSCLC by assessing the survival outcomes, treatment responses and toxicities.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective phase II randomized study is to determine the impact of thymosin alpha-1 on the concurrent chemoradiotherpay followed by immunotherapy consolidation in patients with locally advanced NSCLC by assessing the survival outcomes, treatment responses and toxicities.

Patients with locally advanced NSCLC who will receive concurrent radiochemotherapy followed by immunotherapy consolidation will be randomly divided into two groups (concurrent Tα1 treatment group and control group [in which Tα1 will not be used]), and the overall survivals, progression-free survivals (PFS), completion rate of immunotherapy consolidation, toxicities/adverse effects, and peripheral blood immune biomarkers will be compared between these two groups.

Study Type

Interventional

Enrollment (Actual)

114

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 Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Sun Yat-sen University Cancer Center

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:

  • aged ≥18 years old
  • histologically confirmed locally advanced and unresectable NSCLC;
  • no prior radiotherapy or surgery;
  • with the life expectancy over 12 weeks;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • adequate bone marrow and hepatic and renal functions;
  • informed consent

Exclusion Criteria:

  • Concurrent enrollment in another clinical trial, unless it is an observational (non-interventional) clinical study;
  • With histologically documented combined small-cell lung carcinoma;
  • Major surgery (excluding vascular access placement) within 4 weeks prior to enrollment in the study;
  • 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 innate immunodeficiency;
  • History of organ transplant that requires the use of immunosuppressives;
  • A mean heart rate-corrected QT interval (QTc) ≥ 470 ms, calculated using Bazett correction from 3 ECG calculation cycles;
  • Poorly managed health conditions that include but are not limited to persistent or active infections, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, arrhythmia, active peptic ulcer disease or gastritis, active hemorrhagic diseases, hepatitis C or human immunodeficiency virus (HIV) infection, hepatitis B (positive HBsAg and HBV DNA > 500 IU/ml), and mental disorders/social conditions that may hinder the compliance with the study requirements or the ability to give written informed consent willingly;
  • Active tuberculosis;
  • Receipt of live or attenuated vaccination within 30 days prior to the first dose of the investigational agents;
  • History of another primary malignancy within the past 5 years, excluding adequately treated basal or squamous cell skin cancers or cervical carcinoma in situ;
  • Pregnant/breastfeeding women or males/females of reproductive potential who do not use contraception.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Concurrent Tα-1 group
In this concurrent Tα-1 group, participants receive concurrent chemoradiotherapy followed by immunotherapy consolidation. During this treatment, thymosin alpha-1 was administered at 4.8mg each time.
Drug: induction chemo-immunotherapy
All participants receive two cycles of albumin-bound paclitaxel (260mg/m2) on d1 and cisplatin (25mg/m2) from d1 to d3 in combination with tislelizumab (200mg) on d1.
Other Names:
  • cisplatin
  • albumin-bound paclitaxel
  • tislelizumab
Drug: concurrent chemotherapy
Concurrent chemotherapy consists of weekly albumin-bound paclitaxel (50mg/m2) and cisplatin (25mg/m2).
Other Names:
  • cisplatin
  • albumin-bound paclitaxel
Drug: Immunotheapy consolidation
Participants without disease progression, grade ≥3 toxicities, and/or grade ≥2 pneumonitis after CCRT receive tislelizumab 200 mg (Q3W) for up to 12 months.
Other Names:
  • tislelizumab
Drug: Thymosin Alpha1

Participants in the Tα1 treatment group will receive Tα1 from the beginning of induction chemo-immunotherapy until the completion of immunotherapy consolidation. In detail, Tα-1 would be administered according to the following three stages:

  1. Induction chemo-immunotherapy: Tα-1 will be subcutaneously administered at 4.8 mg on d1 and d3 for each cycle.
  2. Concurrent chemoradiotherapy: Tα-1 will be subcutaneously administered at 4.8mg biweekly.
  3. Immunotherpay consolidation: Tα-1 will be administered concurrently with tislelizumab at 4.8mg (Q3W) for up to 12 months.
Other Names:
  • thymalfasin
Radiation: definitive radiotherapy
Participants were treated with definitive thoracic radiotherapy
Other: Control group
In control group, participants receive concurrent chemoradiotherapy followed by immunotherapy consolidation.
Drug: induction chemo-immunotherapy
All participants receive two cycles of albumin-bound paclitaxel (260mg/m2) on d1 and cisplatin (25mg/m2) from d1 to d3 in combination with tislelizumab (200mg) on d1.
Other Names:
  • cisplatin
  • albumin-bound paclitaxel
  • tislelizumab
Drug: concurrent chemotherapy
Concurrent chemotherapy consists of weekly albumin-bound paclitaxel (50mg/m2) and cisplatin (25mg/m2).
Other Names:
  • cisplatin
  • albumin-bound paclitaxel
Drug: Immunotheapy consolidation
Participants without disease progression, grade ≥3 toxicities, and/or grade ≥2 pneumonitis after CCRT receive tislelizumab 200 mg (Q3W) for up to 12 months.
Other Names:
  • tislelizumab
Radiation: definitive radiotherapy
Participants were treated with definitive thoracic radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion rate of immunotherapy
Time Frame: Calculated from the start of treatment to one year after the last treatment completion
Proportion of participants completing 12 months of consolidation of immutherapy
Calculated from the start of treatment to one year after the last treatment completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 2 years
2 years
Progression-free survival
Time Frame: one year
one year
Incidence of ≥grade 2 pneumonia
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Drop-out rate during the I/O consolidation
Time Frame: One year
One year
The absolute count of total lymphocyte in peripheral blood
Time Frame: Calculated from the start of treatment to one year after the last treatment completion; up to 18 months
Measured at baseline, before immunotherapy, and every 3-4 months thereafter until the end of immunotherapy.
Calculated from the start of treatment to one year after the last treatment completion; up to 18 months
The expression of peripheral blood cytokines (including IL2, IL4, IL6, IL10, TNF-α, and IFN-γ)
Time Frame: Calculated from the start of treatment to one year after the last treatment completion; up to 18 months
Measured at baseline, before immunotherapy, and every 3-4 months thereafter until the end of immunotherapy.
Calculated from the start of treatment to one year after the last treatment completion; up to 18 months
The absolute count of peripheral blood lymphocyte subsets (including CD3+, CD3+CD4+, CD3+CD8+, CD19+, CD3-CD16+CD56+, and CD56+ NK cells, PD-1+CD8+ T cells, Tim3+ CD8+ T cells, CD62lowCD4+ T cells, PD-1+CD4+ T cells, and Tim3+CD4+ T cells
Time Frame: Calculated from the start of treatment to one year after the last treatment completion; up to 18 months
Measured at baseline, before immunotherapy, and every 3-4 months thereafter until the end of immunotherapy.
Calculated from the start of treatment to one year after the last treatment completion; up to 18 months

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Hui Liu, Professor, 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)

July 25, 2023

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

August 30, 2023

First Submitted That Met QC Criteria

November 14, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 13, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GASTO-1098

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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