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

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 toenrollment 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 Bazettcorrection from 3 ECG calculation cycles;

• Poorly managed health conditions that include but are not limited to persistent oractive infections, symptomatic congestive heart failure, poorly controlledhypertension, 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 mentaldisorders/social conditions that may hinder the compliance with the studyrequirements 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 ofthe investigational agents;

• History of another primary malignancy within the past 5 years, excluding adequatelytreated basal or squamous cell skin cancers or cervical carcinoma in situ;

• Pregnant/breastfeeding women or males/females of reproductive potential who do notuse contraception.