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

NCT05611879 | Unknown Phase 2 DMC

• 1 other identifier: 21416-0-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

NSCLC, Stage III

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Major pathological response rate (MPR)

  At time of surgery

• Pathology complete response rate(pCR)

  At time of surgery

• R0 Resection rate

  At time of surgery

• Perioperative G3-4 Adverse Events (AEs)

  Up to 1 month post surgery

Study Arms (1)

Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery

EXPERIMENTAL

Participants will receive neoadjuvant Tislelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection.

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

Interventions

Tislelizumab DRUG

Tislelizumab: 200mg, IV, day 1 of each 21-day cycle, Neoadjuvant therapy : 3 cycles

Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery

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

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.

Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery

Carboplatin DRUG

AUC 5 mg/mL/min by IV infusion Q3W, given on cycle day 2.

Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

tislelizumab; Pemetrexed; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals

Study Officials

• Donghong Chen, Dr.

  Beijing Tsinghua Chang Gung Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fan Yang, Dr.

CONTACT

+86-10-56112345; Yfa01087@btch.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 10, 2022
• Study Start: March 12, 2023
• Primary Completion: February 29, 2024
• Study Completion: April 30, 2024
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)