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RECRUITING
NCT06357598
PHASE4

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

Sponsor: The Affiliated Hospital of Qingdao University

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-01-18

Completion Date

2025-12-31

Last Updated

2024-04-10

Healthy Volunteers

No

Interventions

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.

Locations (1)

the Affiliated Hospital of Qingdao University

Qingdao, Shandong, China