Immuno-effect of Tα1 for Stage I NSCLC

Not Applicable

Recruiting

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: Thymosin Alpha1

• Registration Number: NCT06598839
• Lead Sponsor: Yousheng Mao

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-30
• Status Verified: 2024-09
• Study First Submitted: 2024-09-12
• Study First Submitted QC: 2024-09-12
• Last Update Submitted: 2024-09-12
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tα1 group	Thymosin Alpha1	Tα1 treatment for 3 months after surgery

Primary Outcome Measures

Name	Time	Method
Number of CTCs	4 months after sugery	Number of peripheral blood circulating tumor cells after Tα1 treatment

Secondary Outcome Measures

Name	Time	Method
Number of immune cells	4 months after sugery	Number of TERT+ immnue cells after Tα1 treatment
Peripheral blood immune cells profile	4 months after sugery	Number of immune cells profile, including but limited to CD4+, CD8+, T cells
AE	within 4 months after sugery	the safety profile of the Tα1 treatment

Trial Locations

Locations (1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China