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

November 15, 2025 updated by: Jianhua Fu, Sun Yat-sen University

Preoperative Stereotactic Body Radiotherapy and Tislelizumab (Immunotherapy) Plus Anlotinib for Operable Stage IB to III EGFR Wild-type Non-small Cell Lung Cancer（STATION）

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

39

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Preoperative Stereotactic body radiotherapy and Tislelizumab (immunotherapy) plus Anlotinib
Radiation: SBRT
SBRT 8Gy*3
Drug: Immunotherapy
Tislelizumab (immunotherapy) 200mg Q3W
Drug: antiangiogenesis therapy
Anlotinib 8mg D1-D14 Q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pathologic Complete Response(pCR, rate)
Time Frame: At the time of surgery
At the time of surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Major pathologic response rate(MPR rate)，Disease-free survival（DFS, month），Event-free survival（EFS,month）
Time Frame: Major Pathologic Response (MPR, rate ):At the time of surgery Disease-Free Survival（DFS, month):From enrollment to disease recurrence or death from any cause Event-Free Survival（EFS,month）：From enrollment to the first pre-specified event
Major Pathologic Response (MPR, rate ):At the time of surgery Disease-Free Survival（DFS, month):From enrollment to disease recurrence or death from any cause Event-Free Survival（EFS,month）：From enrollment to the first pre-specified event

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 10, 2025

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

May 30, 2032

Study Registration Dates

First Submitted

July 5, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Estimated)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 15, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STATION

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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