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

ConditionsNeoadjuvant ImmunotherapyNSCLCChemo-free Therapy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • SBRT

    Radiation

    SBRT 8Gy\*3

  • Immunotherapy

    Drug

    Tislelizumab (immunotherapy) 200mg Q3W

  • antiangiogenesis therapy

    Drug

    Anlotinib 8mg D1-D14 Q3W

Treatment groups

39 Participants
are divided into 1 treatment group
Group A: Preoperative Stereotactic body radiotherapy and Tislelizumab (immunotherapy) plus AnlotinibExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Pathologic Complete Response(pCR, rate)

Time frame
At the time of surgery

Secondary outcomes

1

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: