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Trial Title:
Neoadjuvant of Tislelizumab Combined With Chemotherapy Followed by Surgery in Unresectable Stage Ⅲ NSCLC
NCT ID:
NCT05611879
Condition:
NSCLC, Stage III
Conditions: Official terms:
Paclitaxel
Carboplatin
Pemetrexed
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Tislelizumab: 200mg, IV, day 1 of each 21-day cycle, Neoadjuvant therapy : 3 cycles
Arm group label:
Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery
Intervention type:
Drug
Intervention name:
Pemetrexed (Nonsquamous NSCLC) or Paclitaxel/Nab-paclitaxel(Squamous NSCLC)
Description:
Pemetrexed: 500 mg/m^2, IV, day 1 of each 21-day cycle, 3 cycles. Paclitaxel:
60-75mg/m^2, IV, day 1 of each 21-day cycle, 3 cycles. Nab-paclitaxel: 260mg/m^2, IV, day
1 of each 21-day cycle, 3 cycles.
Arm group label:
Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
AUC 5 mg/mL/min by IV infusion Q3W, given on cycle day 2.
Arm group label:
Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Tsinghua Chang Gung Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Fan Yang, Dr.
Phone:
+86-10-56112345
Email:
Yfa01087@btch.edu.cn
Start date:
March 12, 2023
Completion date:
April 30, 2024
Lead sponsor:
Agency:
Beijing Tsinghua Chang Gung Hospital
Agency class:
Other
Source:
Beijing Tsinghua Chang Gung Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05611879
