Study of Tislelizumab for Locally Advanced Non-Small Cell Lung Cancer Following Neoadjuvant Chemotherapy Plus Tislelizumab ± Bevacizumab and Definitive Concurrent Chemoradiation Therapy

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

The phase II Study is to explore the efficacy and safety of Tislelizumab as consolidation therapy in patients with locally advanced non-small cell lung cancer who have not progressed following neoadjuvant chemotherapy plus Tislelizumab ± Bevacizumab and definitive concurrent chemoradiation therapy.

Eligibility criteria

Qualifiers

Provision of signed, written and dated informed consent prior to any study specific procedures;

Male or female aged 18~75 years old;

Patients must have histologically- or cytologically-documented NSCLC who present with locally advanced (Stage III) disease;

Without prior chemotherapy, radiotherapy, surgery, targeted therapy or immunotherapy;

Disqualifiers

Concurrent enrolment in another clinical study, unless it is an observational(non-interventional) clinical study;

Mixed small cell and non-small cell lung cancer histology;

Current or prior use of immunosuppressive medication within 28 days before the first dose of Tislelizumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Systemic steroid administration required to manage toxicities arising from radiation therapy delivered as part of the chemoradiation therapy for NSCLC is allowed.

Prior exposure to any anti-programmed cell death protein(PD)-1 or anti-PD-L1 antibody;

Trial design

Treatments tested in this trial

  • Neoadjuvant chemo-immunotherapy
  • Bevacizumab
  • Radiotherapy
  • Tislelizumab

Treatment groups

116 Participants
are divided into 2 treatment groups

Sponsors and collaborators