Non Small Cell Lung CancerNCT06598839
Immuno-effect of Tα1 for Stage I NSCLC
A study testing Thymosin Alpha1 in people with Non Small Cell Lung Cancer, run by Yousheng Mao at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Thymosin Alpha1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Li Fu contact
China1 site, 1 recruiting
- Recruiting
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
Yousheng Mao, +86-010-67781331, youshengmao@gmail.com
About this study
Official 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
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).
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Thymosin Alpha1
- Keywords
- NSCLC, Thymosin alpha1, CTC, Immunosenescence
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thymosin Alpha1Drug
Also called Tα1, Thymalfasin
subcutaneous injection of Tα1, 1.6mg each time, biw, for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | only observation after surgery |
| Tα1 group | Experimental | Tα1 treatment for 3 months after surgery Receives: Drug: Thymosin Alpha1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of CTCs
Number of peripheral blood circulating tumor cells after Tα1 treatment
Measured: 4 months after sugery
Secondary outcomes (3)
Number of immune cells
Number of TERT+ immnue cells after Tα1 treatment
Measured: 4 months after sugery
Peripheral blood immune cells profile
Number of immune cells profile, including but limited to CD4+, CD8+, T cells
Measured: 4 months after sugery
AE
the safety profile of the Tα1 treatment
Measured: within 4 months after sugery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Jun 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yousheng Mao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yousheng Mao, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Yousheng Mao, Principal investigator, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598839
- Sponsor's protocol ID
- NCC4407
- Other IDs
- NCC4407
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06598839
- Acronym / sponsor ID
- NCC4407
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- NSCLC, Thymosin alpha1, CTC, Immunosenescence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yousheng MaoUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –only observation after surgery |
| Tα1 group | Experimental | Drug: Thymosin Alpha1Tα1 treatment for 3 months after surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thymosin Alpha1Also: Tα1, Thymalfasinsubcutaneous injection of Tα1, 1.6mg each time, biw, for 3 months | Drug | Tα1 group |
Primary outcome
Number of CTCs
Time frame: 4 months after sugery
Number of peripheral blood circulating tumor cells after Tα1 treatment
3 secondary outcomes
Number of immune cells
Time frame: 4 months after sugery
Peripheral blood immune cells profile
Time frame: 4 months after sugery
AE
Time frame: within 4 months after sugery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Fu contact
Yousheng Mao principal investigator
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thymosin Alpha1 in people with Non Small Cell Lung Cancer, run by Yousheng Mao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yousheng Mao (8610-67781331, youshengmao@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of CTCs (time frame: 4 months after sugery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.