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

NSCLC, Stage III Clinical Trial

Official title:

Efficacy and Safety of Tislelizumab With Platinum Doublet Chemotherapy as Neoadjuvant Therapy for Participants With Initially Unresectable Stage III Non-small Cell Lung Cancer: A Single-arm, Phase II Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05611879
• Other study ID #: 21416-0-02
• Status: Recruiting
• Phase: Phase 2
• Start date: March 12, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: December 2023
• Source: Beijing Tsinghua Chang Gung Hospital
• Contact: Fan Yang, Dr.
• Phone: +86-10-56112345
• Email: Yfa01087[@]btch.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 30, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• NSCLC, Stage III

Intervention

Drug:
• Tislelizumab
Tislelizumab: 200mg, IV, day 1 of each 21-day cycle, Neoadjuvant therapy : 3 cycles
• Pemetrexed (Nonsquamous NSCLC) or Paclitaxel/Nab-paclitaxel(Squamous NSCLC)
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.
• Carboplatin
AUC 5 mg/mL/min by IV infusion Q3W, given on cycle day 2.

Locations

Country	Name	City	State
China	Beijing Tsinghua Chang Gung Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tsinghua Chang Gung Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resectability rate	Resectability rate is defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy.	At time of surgery
Secondary	Major pathological response rate (MPR)	MPR rate is defined as the percentage of participants having =10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.	At time of surgery
Secondary	Pathology complete response rate(pCR)	pCR rate is defined as the percentage of participants lacking of evidence of viable tumor cells in the pathological examination of resected specimens.	At time of surgery
Secondary	R0 Resection rate	R0 Resection rate is defined as the percentage of patients who were able to undergo R0 Resection surgery after neoadjuvant therapy.	At time of surgery
Secondary	Perioperative G3-4 Adverse Events (AEs)	The number of participants experiencing an perioperative G3-4 AE will be assessed.	Up to 1 month post surgery