Tislelizumab Plus Chemotherapy for Neoadjuvant Treatment of Resectable Non-small Cell Lung Cancer

Predictive biomarker discovery and clinical trials of the efficacy and safety of tislelizumab combined with chemotherapy in non-small cell lung cancer

Status

Recruiting

Phases

Phase 2

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2200056784

Enrollment

Unknown

Registered

2022-02-16

Start date

2020-10-12

Completion date

Unknown

Last updated

2023-09-11

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

Interventions

single-arm :Tislelizumab Plus Chemotherapy ,Q3W

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Stage II-IIIA Non-small cell lung cancer diagnosed by cytology or histology; 2. Agree to have histologic tumor sample collected; 3. Untreated, resectable non-small cell lung cancer with a diameter larger than 2cm; 4. Agree to have radical surgery; 5. No surgery contraindications decided by thoracic surgeons; 6. At least one measurable focus(RECIST v1.1); 7. Male or female>=18 years old, and=1.5*10^9/L, PLT>=100*10^9/L, HGB>=9g/dL; 10. Liver function: TBIL=2.8g/dL; 11. Renal function: Cr=40mL/min; 12. Written informed consent form being signed.

Exclusion criteria

Exclusion criteria: 1. EGFR sensitive by histologic tumor sample biopsy; 2. Previous anti-cancer therapy, including radiation therapy, chemotherapy, immunotherapy and traditional Chinese medicine therapy; 3. Use of immuno-inhibitory drugs within 4 weeks of initial IBI308 treatment, not including nasal, inhaled or other routes of topical glucocorticoids or physiological doses of systemic glucocorticoids; 4. Known or suspicious active autoimmune disease(congenital or acquired), such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroiditis, etc.; 5. Known allogeneic organ transplantation (excluding cornea) or allogeneic hematopoietic stem cell transplantation; 6. Allergic to monoclonal antibodies; 7. Suffering from interstitial lung disease; 8. Suffering from other serious uncontrolled diseases.

Design outcomes

Primary

Measure	Time frame
drug-related adverse event;surgery complications;	—

Secondary

Measure	Time frame
overall response rate;major pathologic response;disease free survival;recurrence rate of 1 and 2 years;overall survival;Correlation of molecular markers(PD-L1 expression, TMB, etc.) on efficacy and adverse reactions of tislelizumab combined with chemotherapy in NSCLC patients;pathologic complete response;	—

Countries

China

Contacts

Public ContactHao Long

Sun Yat-sen University Cancer Center

longhao@sysucc.org.cn+86 020-87343261

Outcome results

None listed

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