NCT06357598

Preoperative Neoadjuvant Immunotherapy Combined With Chemotherapy for Stage Ⅲ Unresectable Non-small Cell Lung Cancer

Preoperative Neoadjuvant Immunotherapy Combined With Chemotherapy for Newly Diagnosed Stage Ⅲ Unresectable Non-small Cell Lung Cancer: a Open-label, Single-arm Prospective Clinical Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The Affiliated Hospital of Qingdao University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Explorative study, which evaluates the effect of Tislelizumab combined with chemotherapy in neoadjuvant treatment of stage Ⅲ unresectable non-small-cell lung carcinoma.

Detailed description

This is a open-label, single-arm prospective clinical trial to evaluate the efficacy and safety of Tislelizumab combined with chemotherapy in neoadjuvant treatment of newly diagnosed stage Ⅲ unresectable non-small cell lung cancer.

Conditions

• Non-small-cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	Tislelizumab	Tislelizumab: 200mg, ivgtt, day 1 of each 21-day cycle, neoadjuvant therapy : 2-4 cycles; Adjuvant therapy: 16cycles at most.
DRUG	Pemetrexed (Non-squamous NSCLC) or Nab-paclitaxel(Squamous NSCLC)	Pemetrexed: 500 mg/m\^2, ivgtt, day 1 of each 21-day cycle, 2-4 cycles. Nab-paclitaxel: 260mg/m\^2, ivgtt, day 1 of each 21-day cycle, 2-4 cycles.
DRUG	Carboplatin or Cisplatin	Carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 ivgtt on day 1 of each 21-day cycle for 2-4 cycles. Cisplatin: 75 mg/m\^2, ivgtt, day 1 of each 21-day cycle, 2-4 cycles.
PROCEDURE	Surgery	Surgery must be done within the 4th-6th week from day 1 the last cycle of neoadjuvant treatment.

Timeline

• Start date: 2024-01-18
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2024-04-10
• Last updated: 2024-04-10

Locations

1 site across 1 country: China