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

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

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.

Study Overview

• Status: Recruiting
• Conditions: NSCLC, Stage III
• Intervention / Treatment: Drug: Tislelizumab; Drug: Pemetrexed (Nonsquamous NSCLC) or Paclitaxel/Nab-paclitaxel(Squamous NSCLC); Drug: Carboplatin

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Fan Yang, Dr.; Phone Number: +86-10-56112345; Email: Yfa01087@btch.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Tsinghua Chang Gung Hospital
      • Contact: Fan Yang, Dr.; Phone Number: +86-10-56112345; Email: Yfa01087@btch.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery; Participants will receive neoadjuvant Tislelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection.

Drug: Tislelizumab; Tislelizumab: 200mg, IV, day 1 of each 21-day cycle, Neoadjuvant therapy : 3 cycles; Drug: 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.; Drug: Carboplatin; AUC 5 mg/mL/min by IV infusion Q3W, given on cycle day 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Beijing Tsinghua Chang Gung Hospital
• Investigators: Principal Investigator: Donghong Chen, Dr., Beijing Tsinghua Chang Gung Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2023
• Primary Completion (Estimated): February 29, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: November 4, 2022
• First Submitted That Met QC Criteria: November 4, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Folic Acid Antagonists; Carboplatin; Paclitaxel; Pemetrexed; Tislelizumab
• Other Study ID Numbers: 21416-0-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No