Immuno-effect of Tα1 for Stage I NSCLC

Yousheng Mao

Status

Enrolling

Conditions

Non Small Cell Lung Cancer

Treatments

Drug: Thymosin Alpha1

Study type

Interventional

Funder types

Other

Identifiers

NCT06598839

NCC4407 (Other Identifier)

Details and patient eligibility

About

To explore the effect of thymosin alpha 1 (Tα1) on postoperative peripheral blood circulating tumor cells and immunosenescence in patients with early-stage non-small cell lung cancer (NSCLC).

Enrollment

40 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Pathologically confirmed stage I (per AJCC 8th edition) invasive NSCLC
Resectable tumor
undergoing lobectomy and systemic lymph node dessection
Without a previous history of malignant tumors or other concurrent malignancies
Naïve to any anticancer therapies or other immunostimulatory agents
Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-1, with cardiac, pulmonary, hepatic, cerebral, and renal functions capable of withstanding surgery
Aged ≥18 years and ≤75 years
Having signed written informed consent and capable of adhering to the visit schedule and related procedures outlined in the study protocol

Exclusion criteria

With a pathologically confirmed non-invasive NSCLC, including preinvasive lesions, small cell lung cancer, and benign lesions
Post-diagnostic use of immunosuppressive medications or other immunostimulatory agents
With known or suspected active autoimmune disease
Allergic to thymopeptides
With other uncontrolled serious illnesses or having acute or chronic conditions that may confound test outcomes, including active severe clinical infections ( >NCI-CTCAE grade 2 infection); diagnosed with epilepsy requiring antiepileptic treatment; on renal dialysis; with non-healing wounds, ulcers, or fractures; with a history of arteriovenous thrombotic events, including cerebrovascular accident, deep vein thrombosis, and pulmonary embolism, within six months prior to the first dose