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

Sun Yat-sen University logo

Sun Yat-sen University

Status and phase

Not yet enrolling
Phase 2

Conditions

Chemo-free Therapy
NSCLC
Neoadjuvant Immunotherapy

Treatments

Drug: Immunotherapy
Drug: antiangiogenesis therapy
Radiation: SBRT

Study type

Interventional

Funder types

Other

Identifiers

NCT07231575
STATION

Details and patient eligibility

About

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.

Enrollment

39 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

39 participants in 1 patient group

Preoperative Stereotactic body radiotherapy and Tislelizumab (immunotherapy) plus Anlotinib
Experimental group
Treatment:
Radiation: SBRT
Drug: antiangiogenesis therapy
Drug: Immunotherapy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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