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

NCT07231575 | Not Yet Recruiting Phase 2

• 1 other identifier: STATION
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Neoadjuvant Immunotherapy; NSCLC; Chemo-free Therapy

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response(pCR, rate)

  At the time of surgery

Secondary Outcomes (1)

• Major pathologic response rate(MPR rate)，Disease-free survival（DFS, month），Event-free survival（EFS,month）

  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

Study Arms (1)

Preoperative Stereotactic body radiotherapy and Tislelizumab (immunotherapy) plus Anlotinib

EXPERIMENTAL

Radiation: SBRT; Drug: Immunotherapy; Drug: antiangiogenesis therapy

Interventions

SBRT RADIATION

SBRT 8Gy\*3

Preoperative Stereotactic body radiotherapy and Tislelizumab (immunotherapy) plus Anlotinib

Immunotherapy DRUG

Tislelizumab (immunotherapy) 200mg Q3W

Preoperative Stereotactic body radiotherapy and Tislelizumab (immunotherapy) plus Anlotinib

antiangiogenesis therapy DRUG

Anlotinib 8mg D1-D14 Q3W

Preoperative Stereotactic body radiotherapy and Tislelizumab (immunotherapy) plus Anlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Interventions

Immunotherapy

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: November 17, 2025
• Study Start: November 10, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): May 30, 2032
• Last Updated: November 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share