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Recruiting

NCT Number: NCT06598839

Immuno-effect of Tα1 for Stage I NSCLC

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).

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

Location status: Recruiting

Location contact

Yousheng Mao

CONTACT

[email protected]

+86-010-67781331

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thymosin Alpha1

Drug

subcutaneous injection of Tα1, 1.6mg each time, biw, for 3 months

Other names: Tα1, Thymalfasin

Primary outcomes

  1. Number of CTCs

    Time frame: 4 months after sugery

    Number of peripheral blood circulating tumor cells after Tα1 treatment

Secondary outcomes

  1. Number of immune cells

    Time frame: 4 months after sugery

    Number of TERT+ immnue cells after Tα1 treatment

  2. Peripheral blood immune cells profile

    Time frame: 4 months after sugery

    Number of immune cells profile, including but limited to CD4+, CD8+, T cells

  3. AE

    Time frame: within 4 months after sugery

    the safety profile of the Tα1 treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Li Fu

CONTACT

[email protected]

Yousheng Mao

CONTACT

[email protected]

8610-67781331

Sponsors and collaborators

Lead sponsor

Yousheng Mao

Other

Registry information

Official study title

Assessment of the Efficacy of Immunomodulatory Therapy With Thymosin Alpha 1 (Tα1) Following Surgical Resection in Patients With Stage I Non-Small Cell Lung Cancer

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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