RecruitingPhase 4NCT06357598

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


Sponsor

The Affiliated Hospital of Qingdao University

Enrollment

30 participants

Start Date

Jan 18, 2024

Study Type

INTERVENTIONAL

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether giving immunotherapy (a treatment that boosts the immune system) combined with chemotherapy before surgery can help make inoperable Stage III non-small cell lung cancer (NSCLC) resectable — meaning surgeons may then be able to remove it. **You may be eligible if...** - You are 18–75 years old - You have been newly diagnosed with Stage III NSCLC that cannot be fully removed by surgery right now - Your cancer does not carry EGFR or ALK gene mutations - You have not had any prior treatment (no chemo, radiation, surgery, or targeted therapy) for this cancer - You are in generally good health (able to perform daily activities) - Your heart and lungs are strong enough for potential future surgery **You may NOT be eligible if...** - You have an autoimmune disease (like lupus, rheumatoid arthritis, or inflammatory bowel disease) - You have HIV, active hepatitis B, or hepatitis C - You have had another cancer in the last 5 years - You have pulmonary fibrosis or severe lung disease - You have poorly controlled high blood pressure or serious heart problems - You are pregnant or breastfeeding - You have previously received immunotherapy (anti-PD-1/PD-L1 drugs) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTislelizumab

Tislelizumab: 200mg, ivgtt, day 1 of each 21-day cycle, neoadjuvant therapy : 2-4 cycles; Adjuvant therapy: 16cycles at most.

DRUGPemetrexed (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.

DRUGCarboplatin 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.

PROCEDURESurgery

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

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NCT06357598