Neoadjuvant of Tislelizumab Combined With Chemotherapy Followed by Surgery in Unresectable Stage Ⅲ NSCLC

• Status: Recruiting
• Trial end date: 2024-04-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this conversion therapy study is to evaluate the safety and efficacy of neoadjuvant of Tislelizumab combined with platinum doublet for stage III unresectable locally advanced NSCLC.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tsinghua Chang Gung Hospital
• Treatments: Carboplatin; Paclitaxel; Pemetrexed

Criteria

Inclusion Criteria:

• Written informed consent provided.

• Unresectable stage III non-small cell lung cancer confirmed by histopathology or cytology.

• ECOG score is 0 or 1.

• Adequate hematological function, liver function and renal function.

Exclusion Criteria:

• Previously received systemic anti-tumor therapy for non-small cell lung cancer.

• history or current (non-infectious) pneumonia/interstitial pneumonia requiring steroid treatment.

• History or active pulmonary tuberculosis.

• Active infections that require systemic treatment.

• History or suspected autoimmune disease or immune deficiency who, in the judgment of the investigator, cannot tolerate immunotherapy.

• Untreated active Hepatitis B.

• Has a known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive).

• Grade 3 or above peripheral neuropathy.

• Severe allergic history to pemetrexed, paclitaxel, albumin-bound paclitaxel, carboplatin or other preventive drugs.

• Underlying severe or uncontrolled disease.

• Malignant tumors other than NSCLC within 5 years.

• Any medical condition requiring systemic treatment with corticosteroids (prednisone or equivalent at a dose of >10mg/ day) or other immunosuppressive agents within 14 days prior to treatment.