Resectable Non-Small-Cell Lung CancerNCT06607926
Neoadjuvant With Tα1 Plus Immuno-chemotherapy for Resectable NSCLC
A study testing Thymosin Alpha 1, Tislelizumab and Platinum-doublet chemotherapy in people with Resectable Non-Small-Cell Lung Cancer, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This study aims to explore the efficacy and safety of thymosin α-1 (Tα1) plus chemotherapy and PD-1 inhibitors as neoadjuvant therapy for operable non-small cell lung cancer Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Resectable Non-Small-Cell Lung Cancer
- What is being tested?
- Thymosin Alpha 1, Tislelizumab and Platinum-doublet chemotherapy
- 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
- 15 Oct 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged ≥ 18 years and ≤ 70 years
- With operable NSCLC confirmed by imaging studies and histopathology. (Stage II-IIIB[N2], according to the 8th Edition of the American Joint Committee on Cancer (AJCC-TNM) Staging Manual). Operable NSCLC, as defined by the Multidisciplinary Consensus Statement on the Clinical Management of Patients with Stage III Non-Small Cell Lung Cancer (2019 edition), includes resectable and potentially resectable cases. Resectable stage III NSCLC mainly includes stage IIIA N0-1, N2 with a single mediastinal lymph node metastasis and a short diameter \< 2 cm and some T4N1 (with solitary carcinomatous nodules in different lobes of the same lung). Potentially resectable stage III NSCLC includes some IIIA and IIIB tumors, usually including a single N2 mediastinal lymph node with a short diameter \< 3 cm, a potentially resectable superior sulcus tumor, and a potentially resectable T3 or T4 central tumor.
- Presence of at least one measurable lesion on imaging as per the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Negative for EGFR and ALK driver mutations
- With an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 - 1.
- With a life expectancy \> 6 months.
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- No prior systemic treatment (including surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy) for lung cancer.
- Informed consent to undergo radical surgery.
- No contraindications to surgery, as assessed by a thoracic surgeon.
- With adequate organ function, and with laboratory test results meeting the following criteria:
- Absolute neutrophil count (ANC) ≥ 1.5×10^9/L without the use of granulocyte colony-stimulating factor in the past 14 days
- Platelet count ≥ 100×10^9/L without blood transfusion in the past 14 days
- Hemoglobin (Hb) level ≥ 90 g/L without blood transfusion or erythropoietin administration in the past 14 days.
- Serum creatinine ≤ 1.5 × upper limit of normal (ULN) and creatinine clearance (calculated by the Cockcroft-Gault equation) ≥ 60 mL/min.
- Total bilirubin ≤ 1.5×ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN.
- Good coagulation, defined as prothrombin time/international normalized ratio (INR) ≤ 1.5 × ULN.
- Normal thyroid function, defined as thyroid-stimulating hormone (TSH) level within the reference range. Subjects with baseline TSH level beyond the normal range may also be enrolled if total T3 (or free T3) and free T4 levels are within the normal range.
- The cardiac enzyme levels are within the normal limits (enrollment is also permitted if the investigator deems laboratory abnormalities as clinically insignificant).
- Females of childbearing potential must agree to use contraceptive methods throughout the study and for 6 months post-study. Patients must have a negative serum or urine pregnancy test within 7 days prior to enrollment and should not be lactating. Male patients must agree to use contraceptive methods throughout the study and for 6 months post-study.
- Subjects have full understanding of the study and voluntarily sign the informed consent form before any trial-related procedure is initiated.
Who cannot join
- History of other malignancies within 5 years prior to the initial dose, excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ following radical resection.
- Positive for EGFR and ALK driver mutations or unknown
- Ongoing participation in another interventional clinical trial, or receipt of other investigational agents or devices within 4 weeks prior to the first dose.
- Prior multidisciplinary treatment for lung cancer, including but not limited to surgery, radiotherapy, chemotherapy, and/or immunotherapy (e.g., PD-1 or PD-L1 inhibitors and CTLA-4 inhibitors).
- Use of systemic therapy with anti-tumor traditional Chinese patent medicines or immunomodulatory drugs (including thymopeptides, interferons, and interleukins, except for topical use for pleural effusions) within 2 weeks before the first dose.
- Active autoimmune disease necessitating systemic treatment (e.g., disease-modifying drugs, glucocorticoids, and immunosuppressants) within 2 years before the first dose. Replacement therapies such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency are not classified as systemic therapy.
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- Use of systemic glucocorticoid therapy (excluding intranasal, inhaled, or other topical applications) or any other immunosuppressive treatment within 7 days before the first dose. Note: Glucocorticoids at physiological doses (≤ 10 mg/day of prednisone or equivalent) are allowed.
- History of allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
- Allergic to the active substance or excipients of the study drug.
- Incomplete recovery from toxicity and/or complications due to prior interventions (i.e., ≤ grade 1 or baseline, excluding fatigue and alopecia) before treatment initiation.
- Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV-1/2 antibody).
- Untreated active hepatitis B, defined as positive HBsAg along with HBV-DNA levels exceeding the ULN as determined by the clinical laboratory of the research center. Note: Subjects with hepatitis B may be eligible if they meet the following criteria:
- The HBV viral load is \< 1000 copies/mL (200 IU/mL) before the first dose, with subjects being required to undergo anti-HBV therapy throughout chemotherapy to prevent viral reactivation.
- For subjects with anti-HBc(+), HBsAg(-), anti-HBs(-), and HBV viral load (-), no HBV prophylaxis is required, although viral reactivation should be monitored closely.
- Subjects with active hepatitis C virus (HCV) infection, defined as positive HCV antibody and HCV-RNA levels above the threshold of detection.
- Administration of a live vaccine within 30 days before the first dose. Note: administration of inactivated influenza vaccine by injection within 30 days before the first dose is allowed; however, subjects with a history of administration of intranasal live attenuated influenza vaccines will be excluded.
- Pregnant or lactating women.
- Subjects with any severe or uncontrolled systemic condition, including but not limited to:
- Significant resting ECG abnormalities in rhythm, conduction, or morphology (e.g., complete left bundle branch block, second- and higher-degree heart block, ventricular arrhythmias, or atrial fibrillation), corresponding to severe and difficult-to-control symptoms.
- Unstable angina, congestive heart failure, or New York Heart Association (NYHA) class ≥ 2 chronic heart failure.
- History of arterial thrombosis, embolism, or ischemia, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months preceding enrollment.
- Uncontrolled blood pressure, with systolic blood pressure (SBP) \> 140 mmHg or diastolic blood pressure (DBP) \> 90 mmHg.
- History of non-infectious pneumonitis necessitating glucocorticoid therapy within 1 year before the first dose, or current clinically active interstitial lung disease.
- Active tuberculosis.
- Active or uncontrolled infection requiring systemic treatment.
- Clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.
- Liver diseases, including cirrhosis, decompensated liver disease, and acute/chronic active hepatitis.
- Poorly controlled diabetes mellitus, with fasting blood glucose (FBG) \> 10 mmol/L.
- Urine protein ≥++ on routine urinalysis, along with a 24-hour urine protein level of \> 1.0 g.
- A psychiatric disorder that limits the patient's ability to comply with the treatment or to follow the protocol.
- A history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study; or, any condition that is judged by the Investigator to be inappropriate for the study.
Trial locations and contacts
1 site in 1 country.
Yi Zhang, MD, PhD contact
China1 site
Xuanwu Hospital, Capital Medical University
Beijing, 100053
Yi Zhang, 86-010-83922345, steven9130@sina.com
Yi Zhang
About this study
Official title: Efficacy and Safety of Thymosin α1 Plus Immune Checkpoint Inhibitors and Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Stage II - IIIB Non Small Cell Lung Cancer: A Prospective, Multicenter, Randomized, Controlled Trial
This study aims to explore the efficacy and safety of thymosin α-1 (Tα1) plus chemotherapy and PD-1 inhibitors as neoadjuvant therapy for operable non-small cell lung cancer
- Conditions
- Resectable Non-Small-Cell Lung Cancer
- Being tested
- Thymosin Alpha 1, Tislelizumab, Platinum-doublet chemotherapy
- Keywords
- non-small-cell lung cancer, resectable, thymosin alpha-1, PD-1 inhibitor, pCR
- 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 Alpha 1Drug
Also called thymalfasin
4.8 mg subcutaneous injection twice weekly over 12 weeks
TislelizumabDrug
200mg, IV, d1 of each 21-d cycle, four cycles
Platinum-doublet chemotherapyDrug
Chemotherapy regimen: (1) for squamous cell carcinoma: cisplatin/carboplatin + paclitaxel; and (2) for non-squamous cell carcinoma: cisplatin/carboplatin + pemetrexed.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Neoadjuvant therapy with platinum-doublet chemotherapy plus tislelizumab for four cycles, followed by surgery and adjuvant therapy. Receives: Drug: Tislelizumab; Drug: Platinum-doublet chemotherapy |
| Experimental group | Experimental | Neoadjuvant therapy with platinum-doublet chemotherapy plus tislelizumab and Tα1 for four cycles, followed by surgery and adjuvant therapy. Receives: Drug: Thymosin Alpha 1; Drug: Tislelizumab; Drug: Platinum-doublet chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response rate
The rate of no viable tumor cells in the resected specimen including lymph node region evaluated by H\&E staining
Measured: at the time of surgey
Secondary outcomes (3)
major pathological response rate
The rate of ≤ 10% viable tumor cells in the resected specimen evaluated by H\&E staining
Measured: at the time of surgey
Rate of R0 resection
The rate of participants undergoing R0 resection
Measured: at the time of surgey
Incidence of irAE
The occurrence rate of immune-related adverse events
Measured: From the first dose of PD-1 inhibitors to the three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start15 Oct 2024 (estimated)
- Primary completion30 Jun 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 Resectable Non-Small-Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- 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
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhang yi, Xuanwu Hospital, Beijing
- Investigators
- Yi Zhang, Study director, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607926
- Sponsor's protocol ID
- XWh-NSCLC-NEO-ZDX
- Status last verified
- Sep 2024
- First submitted
- 17 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- 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 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Thymosin α1 Plus Immune Checkpoint Inhibitors and Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Stage II - IIIB Non Small Cell Lung Cancer: A Prospective, Multicenter, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT06607926
- Acronym / sponsor ID
- XWh-NSCLC-NEO-ZDX
- Conditions
- Resectable Non-Small-Cell Lung Cancer
- Keywords
- non-small-cell lung cancer, resectable, thymosin alpha-1, PD-1 inhibitor, pCR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 23 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.
This study aims to explore the efficacy and safety of thymosin α-1 (Tα1) plus chemotherapy and PD-1 inhibitors as neoadjuvant therapy for operable non-small cell lung cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Tislelizumab, Drug: Platinum-doublet chemotherapyNeoadjuvant therapy with platinum-doublet chemotherapy plus tislelizumab for four cycles, followed by surgery and adjuvant therapy. |
| Experimental group | Experimental | Drug: Thymosin Alpha 1, Drug: Tislelizumab, Drug: Platinum-doublet chemotherapyNeoadjuvant therapy with platinum-doublet chemotherapy plus tislelizumab and Tα1 for four cycles, followed by surgery and adjuvant therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Males and females aged ≥ 18 years and ≤ 70 years
- With operable NSCLC confirmed by imaging studies and histopathology. (Stage II-IIIB[N2], according to the 8th Edition of the American Joint Committee on Cancer (AJCC-TNM) Staging Manual). Operable NSCLC, as defined by the Multidisciplinary Consensus Statement on the Clinical Management of Patients with Stage III Non-Small Cell Lung Cancer (2019 edition), includes resectable and potentially resectable cases. Resectable stage III NSCLC mainly includes stage IIIA N0-1, N2 with a single mediastinal lymph node metastasis and a short diameter \< 2 cm and some T4N1 (with solitary carcinomatous nodules in different lobes of the same lung). Potentially resectable stage III NSCLC includes some IIIA and IIIB tumors, usually including a single N2 mediastinal lymph node with a short diameter \< 3 cm, a potentially resectable superior sulcus tumor, and a potentially resectable T3 or T4 central tumor.
- Presence of at least one measurable lesion on imaging as per the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Negative for EGFR and ALK driver mutations
- With an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 - 1.
Key exclusion criteria (31 listed)
- History of other malignancies within 5 years prior to the initial dose, excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ following radical resection.
- Positive for EGFR and ALK driver mutations or unknown
- Ongoing participation in another interventional clinical trial, or receipt of other investigational agents or devices within 4 weeks prior to the first dose.
- Prior multidisciplinary treatment for lung cancer, including but not limited to surgery, radiotherapy, chemotherapy, and/or immunotherapy (e.g., PD-1 or PD-L1 inhibitors and CTLA-4 inhibitors).
- Use of systemic therapy with anti-tumor traditional Chinese patent medicines or immunomodulatory drugs (including thymopeptides, interferons, and interleukins, except for topical use for pleural effusions) within 2 weeks before 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 Alpha 1Also: thymalfasin4.8 mg subcutaneous injection twice weekly over 12 weeks | Drug | Experimental group |
| Tislelizumab200mg, IV, d1 of each 21-d cycle, four cycles | Drug | Control group, Experimental group |
| Platinum-doublet chemotherapyChemotherapy regimen: (1) for squamous cell carcinoma: cisplatin/carboplatin + paclitaxel; and (2) for non-squamous cell carcinoma: cisplatin/carboplatin + pemetrexed. | Drug | Control group, Experimental group |
Primary outcome
Pathologic complete response rate
Time frame: at the time of surgey
The rate of no viable tumor cells in the resected specimen including lymph node region evaluated by H\&E staining
3 secondary outcomes
major pathological response rate
Time frame: at the time of surgey
Rate of R0 resection
Time frame: at the time of surgey
Incidence of irAE
Time frame: From the first dose of PD-1 inhibitors to the three months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 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.
Yi Zhang, MD, PhD contact
Yi Zhang study director
Xuanwu Hospital, Beijing
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 Alpha 1, Tislelizumab and Platinum-doublet chemotherapy in people with Resectable Non-Small-Cell Lung Cancer, run by Xuanwu Hospital, Beijing 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 20 inclusion and 31 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 23 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 Xin Zhao, MD (+86-010-83922345, zx89316@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response rate (time frame: at the time of surgey). 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 23 Sep 2024.