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

Beijing Tsinghua Chang Gung Hospital

Status and phase

Enrolling

Phase 2

Conditions

NSCLC, Stage III

Treatments

Drug: Carboplatin

Drug: Tislelizumab

Drug: Pemetrexed (Nonsquamous NSCLC) or Paclitaxel/Nab-paclitaxel(Squamous NSCLC)

Study type

Interventional

Funder types

Other

Identifiers

NCT05611879

21416-0-02

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.