Status:
ACTIVE_NOT_RECRUITING
The Impact of Thymosin α-1 on the Efficacy of Concurrent Chemoradiotherapy Followed by Immunotherpay Consolidation for Locally Advanced NSCLC
Lead Sponsor:
Sun Yat-sen University
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2026
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT06139419
Start Date
July 25 2023
End Date
August 30 2026
Last Update
November 17 2025
Active Locations (1)
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1
Sun yat-sen university cancer center
Guangzhou, Guangdong, China, 510000