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Application and demonstration of tislelizumab in adjuvant treatment of stage II-IIIA NSCLC

Application and demonstration of tislelizumab in adjuvant treatment of stage II-IIIA NSCLC

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060484
Enrollment
Unknown
Registered
2022-06-03
Start date
2022-06-01
Completion date
Unknown
Last updated
2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung cancer (NSCLC)

Interventions

Sponsors

Affiliated Hospital of Zunyi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Obtain written informed consent from patients; 2. Aged 18-75 years, no gender limit; 3. Pathologically confirmed patients with stage ?-?A NSCLC (UICC/AJCC Stage 8); 4. Have received lobectomy or pneumonectomy; 5. EGFR driver gene mutation negative; 6. ECOG PS score =1.5x10^9/L, platelet >=100x10^9/L, hemoglobin >=90 g/L; 9. Blood biochemical examination: ALT and AST < 2.5 times the upper limit of normal value; Crea < 1.5 times the upper limit of normal value; 10. Good follow-up compliance; 11. Fertile patients must consent to the use of effective contraceptive measures to ensure that they do not become pregnant during and for three months after the test.

Exclusion criteria

Exclusion criteria: 1. Any systemic anticancer therapy for NSCLC before or after surgery, including cytotoxic drug therapy, targeted drug therapy (including tyrosine kinase inhibitors or monoclonal antibodies), experimental therapy; 2. Local radiotherapy for NSCLC; 3. Patients with cancers other than NSCLC (except cured cervical carcinoma in situ, cured basal cell carcinoma, and bladder epithelial tumor) within 5 years prior to the start of treatment in this study; 4. Had any medical condition requiring systemic therapy with corticosteroids (daily dose > 10 mg prednisone or equivalent) or other immunosuppressive agents during the 14 days prior to enrollment; The use of epinephrine substitute steroids (prednisone or equivalent at a daily dose of > 10 mg) for topical, ocular, intra-articular, intranasal, or inhaled corticosteroids is permitted with minimum systemic absorption and short-term (>=7 days) use of prescribed corticosteroids, or to treat non-autoimmune diseases, active autoimmune diseases, or a history of autoimmune diseases that may recur; 5. Severe infections, including but not limited to hospitalization due to infection complications, bacteremia, or severe pneumonia, occurred within 4 weeks prior to enrollment; 6. Severe chronic or active infections (including tuberculosis) requiring systemic (oral or intravenous) antibiotics within 14 days prior to enrollment; 7. History of interstitial pulmonary disease, non-infectious pneumonia or poorly controlled diseases, including pulmonary fibrosis and acute pulmonary disease; 8. Patients with untreated chronic hepatitis B or hepatitis B virus (HBV) DNA>= 500 IU/mL who are HBV carriers, or those with active hepatitis C virus (HCV) should be excluded. Note: Non-active hepatitis B, surface antigen (HBsAg) carriers, treated and stable hepatitis B carriers (HBV DNA < 500 IU/mL), cured hepatitis C patients could be enrolled; 9. Received any other investigational drug treatment or participated in other clinical trials within 28 days; 10. Patients with poor compliance, in violation of the provisions of test; 11. Conditions considered unsuitable for inclusion by other researchers.

Design outcomes

Primary

MeasureTime frame
Disease free survival;

Countries

China

Contacts

Public ContactQu Wendong

Affiliated Hospital of Zunyi Medical University

quwendonga@126.com+86 13765911742

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026