RecruitingPhase 2NCT06379087

Radiation Therapy Followed by Tislelizumab and Anlotinib Aeoadjuvant/Adjuvant Therapy for Stage II-IIIA NSCLC

Prospective Phase II Study of Hypofractionated Radiotherapy Sequential Tislelizumab and Anlotinib in the Neoadjuvant and Adjuvant Therapy for Stage II-IIIA Non-Small Cell Lung Cancer

Sponsor

Ji Yongling

Enrollment

20 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Summary

This study is a single-center, prospective, single-arm exploratory clinical study of hypofractionated radiotherapy followed by tislelizumab and anlotinib neoadjuvant and adjuvant therapy. It is designed for patients with stage II-IIIA non-small cell lung cancer. The efficacy and safety of hypofractionated radiotherapy sequential tislelizumab and anlotinib in the neoadjuvant and adjuvant treatment of stage II-IIIA non-small cell lung cancer are observed. Finally, it provides new evidence-based medical evidence for the perioperative treatment of non-small cell lung cancer.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether giving immunotherapy drugs (tislelizumab and anlotinib) before and after surgery — along with a short course of radiation before surgery — improves outcomes for patients with early-stage non-small cell lung cancer (NSCLC). **You may be eligible if...** - You are between 18 and 75 years old - You have stage II or IIIA non-small cell lung cancer confirmed by tissue testing - Your tumor does not have EGFR, ALK, or ROS1 gene changes - Your tumor can be surgically removed - You are in good general health (ECOG 0-1) - You are expected to live at least 1 more year - You are using contraception if you are able to become pregnant **You may NOT be eligible if...** - Your tumor has EGFR, ALK, or ROS1 mutations - Your cancer is not surgically removable - You are pregnant or breastfeeding - You have serious heart, liver, or kidney problems 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

DRUGAnlotinib Hydrochloride Capsule

Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor that inhibits both tumor angiogenesis and tumor cell proliferation by blocking VEGFR, FGFR, PDGFR, and c-Kit simultaneously.

DRUGTislelizumab Injection

Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody.

RADIATIONHypofractionated Radiotherapy

Hypofractionated Radiotherapy Extent of radiotherapy: Primary lesion in the lung. Radiotherapy technique: IGRT. Radiotherapy delivery equipment: linear accelerator or TOMO accelerator or CyberKnife.

Locations(1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

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NCT06379087