Stage III Non-small Cell Lung Cancer
Conditions
Brief summary
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.
Interventions
The neoadjuvant chemo-immunotherapy before radiotherapy comprised of chemotherapy plus Tislelizumab \[200 mg, once every 3 weeks (Q3W)\].
DRUGBevacizumab
The Bevacizumab was administrated concurrently with neoadjuvant chemo-immunotherapy (7.5mg/kg) once every 3 weeks (Q3W).
RADIATIONRadiotherapy
Definitive radiotherapy to the thoracic lesions.
DRUGTislelizumab
Tislelizumab 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.
Sponsors
Sun Yat-sen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* For inclusion in neoadjuvant therapy, patients should fulfil the following criteria: * 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; * A recent tumour biopsy (taken following completion of the most recent therapy) is an optional requirement, provided that a biopsy procedure is technically feasible and the procedure is not associated with unacceptable clinical risk; * Life expectancy ≥12 weeks; * World Health Organization (WHO) Performance Status of 0 or 1; * Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients within 14 days before the use of study drug (HCG has a minimum sensitivity of 25 IU/L or equivalent); * Women must be non-breastfeeding * Forced expiratory volume in 1 second (FEV1) ≥800ml * Absolute neutrophil count \>1.5 x 109/L (1500 per mm3) * Platelets \>100 x 109/L (100,000 per mm3) * Haemoglobin≥9.0 g/dL (5.59 mmol/L) * Serum creatinine clearance(CL) \>50 mL/min by the Cockcroft-Gault formula (Cockcroft and -Gault 1976) * Serum bilirubin ≤1.5 x upper limit of normal (ULN). Aspartate Transaminase(AST) and Alanine Transaminase(ALT) ≤2.5 x ULN
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 2-year | From the start date of initial treatment to progression, death or last follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 2-year | From the start date of initial treatment to death or to last follow-up. |
| Adverse Event | 2-year | Toxicities were evaluated using the CTCAE 5.0 |
| Health-related Quality of Life | 2-year | An individual's or perceived physical and mental health during and after treatment. |
| Objective response rate | 2-year | Tumor response to neoadjuvant immuno-chemotherapy and radiotherapy based on RECIST 1.1 |
Countries
China
Contacts
Primary ContactBo Qiu, MD
Backup ContactDaQuan Wang, MD
Outcome results
None listed