New drug combo aims to boost immunotherapy success in lung cancer
NCT ID NCT06139419
First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times
Summary
This study tests whether adding thymosin alpha 1 to standard chemoradiation and immunotherapy helps patients with advanced non-small cell lung cancer complete a full year of immunotherapy. About 114 adults will participate. The goal is to see if this approach improves survival and reduces treatment-related lung inflammation.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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114 people
The number who actually took part.
- Started
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Jul 2023
- Finished
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Jun 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sun yat-sen university cancer center
Guangzhou, Guangdong, 510000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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