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.
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;
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;
Parallel
Neoadjuvant chemo-immunotherapy
DrugThe neoadjuvant chemo-immunotherapy before radiotherapy comprised of chemotherapy plus Tislelizumab \[200 mg, once every 3 weeks (Q3W)\].
Bevacizumab
DrugThe Bevacizumab was administrated concurrently with neoadjuvant chemo-immunotherapy (7.5mg/kg) once every 3 weeks (Q3W).
Radiotherapy
RadiationDefinitive radiotherapy to the thoracic lesions.
Tislelizumab
DrugTislelizumab consolidation (200 mg) is performed once every 3 weeks after the neoadjuvant therapy and concurrent chemo-radiotherapy, and will continue on a Q3W schedule for a maximum duration of 12 months.
Progression free survival
From the start date of initial treatment to progression, death or last follow-up.
Overall survival
From the start date of initial treatment to death or to last follow-up.
Adverse Event
Toxicities were evaluated using the CTCAE 5.0
Health-related Quality of Life
An individual's or perceived physical and mental health during and after treatment.
Objective response rate
Tumor response to neoadjuvant immuno-chemotherapy and radiotherapy based on RECIST 1.1
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