NCT06139419CompletedPhase 2
The Impact of Thymosin α-1 on the Efficacy of Concurrent Chemoradiotherapy Followed by Immunotherpay Consolidation for Locally Advanced NSCLC
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
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 114 (actual)
- First submitted
- 30 Aug 2023
- Start date
- 25 Jul 2023
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Lung cancer
- NCT number
- NCT06139419
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 114
- From 25 Jul 2023 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent enrollment in another clinical trial, unless it is an observational (non-interventional) clinical study;
- 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);
- Receipt of live or attenuated vaccination within 30 days prior to the first dose of the investigational agents;
Other illness
- History of innate immunodeficiency;
- History of organ transplant that requires the use of immunosuppressives;
- 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;
- History of another primary malignancy within the past 5 years, excluding adequately treated basal or squamous cell skin cancers or cervical carcinoma in situ;
Lab values
- A mean heart rate-corrected QT interval (QTc) ≥ 470 ms, calculated using Bazett correction from 3 ECG calculation cycles;
Other
- With histologically documented combined small-cell lung carcinoma;
- Pregnant/breastfeeding women or males/females of reproductive potential who do not use contraception.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.