Thymosin α-1's effect on treatment for advanced lung cancer
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 study is testing whether adding thymosin alpha-1 to standard treatment can help people with advanced lung cancer live longer and respond better to their therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06139419 on ClinicalTrials.gov |
What this trial studies
This phase II randomized study investigates the impact of thymosin alpha-1 on the efficacy of concurrent chemoradiotherapy followed by immunotherapy consolidation in patients with locally advanced non-small cell lung cancer (NSCLC). Participants will be randomly assigned to receive either thymosin alpha-1 alongside their treatment or standard care without it. The study aims to evaluate survival outcomes, treatment responses, and any associated toxicities. By comparing these two groups, researchers hope to determine the potential benefits of thymosin alpha-1 in enhancing treatment effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed locally advanced and unresectable NSCLC who have not received prior radiotherapy or surgery.
Not a fit: Patients with active autoimmune diseases, prior small-cell lung carcinoma, or those requiring immunosuppressive therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve survival rates and treatment responses for patients with locally advanced NSCLC.
How similar studies have performed: While the use of thymosin alpha-1 in this context is relatively novel, similar studies have shown promise in enhancing treatment outcomes for cancer patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong
- Sun yat-sen university cancer center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Hui Liu, Professor — Sun Yat-sen University
- Study coordinator: Bo Qiu, Professor
- Email: qiubo@sysucc.org.cn
- Phone: +86-020-87343031
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.