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Neoadjuvant SBRT and Tisleliz...

Neoadjuvant SBRT and Tislelizumab (Immunotherapy) Plus Anlotinib for Resectable EGFR Wild-type NSCLC

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-10

Study Completion Date

2032-05-30

Brief Summary

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The neoadjuvant strategy of immunotherapy combined with chemotherapy has been recommended for resectable or potentially resectable tumors without driver-gene alterations.However, the AE of chemotherapy is more than 40%，which bring fear to the patients，especially for those who cannot tolerate or refuse chemotherapy.Several studies indicated that the strategies of chemo-free ,such as the combination of immunotherapy with antiangiogenic therapy or with SBRT, were safe and well tolerated, without increasing adverse reactions. Both of them have a promising efficacy with a manageable toxicity profile in patients with resectable NSCLC. The investigators aim to assess the activity and safety of neoadjuvant SBRT and immunotherapy plus antiangiogenic therapy in patients with resectable NSCLC.

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Detailed Description

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Conditions

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Neoadjuvant Immunotherapy NSCLC Chemo-free Therapy

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Preoperative Stereotactic body radiotherapy and Tislelizumab (immunotherapy) plus Anlotinib

Group Type EXPERIMENTAL

SBRT

Intervention Type RADIATION

SBRT 8Gy\*3

Immunotherapy

Intervention Type DRUG

Tislelizumab (immunotherapy) 200mg Q3W

antiangiogenesis therapy

Intervention Type DRUG

Anlotinib 8mg D1-D14 Q3W

Interventions

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SBRT

SBRT 8Gy\*3

Intervention Type RADIATION

Immunotherapy

Tislelizumab (immunotherapy) 200mg Q3W

Intervention Type DRUG

antiangiogenesis therapy

Anlotinib 8mg D1-D14 Q3W

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1.18 years or older 2. Eastern Cooperative Oncology Group performance status: 0 or 1 3. Clinical stage IB to IIIB (T3-4N2) Resectable NSCLC 4. Adequate cardiopulmonary and haematological function.

Exclusion Criteria

1. Known EGFR-sensitising mutations and EML4-ALK fusions
2. Concomitant malignancy, history of another cancer within the past 3 years.
3. Current or previous use of immunosuppressive medication,active autoimmune disease, and interstitial lung disease or idiopathic pulmonary fibrosis on a screening radiographic scan

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers