A Phase II Trial 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

Status: Recruiting
Location: See location...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Bo Qiu, MD
qiubo@sysucc.org.cn
+86-020-87343031
Backup
DaQuan Wang, MD
wangdq@sysucc.org.cn
+86-020-87343031
Time Frame
Start Date: 2022-01-01
Estimated Completion Date: 2024-12-30
Participants
Target number of participants: 116
Treatments
Experimental: Neoadjuvant Chemotherapy Plus Tislelizumab + Bevacizumab
Patients in experimental group will receive Tislelizumab consolidation (200 mg/q3w) after the neoadjuvant chemotherapy plus Tislelizumab + Bevacizumab and concurrent chemoradiotherapy.
Active_comparator: Neoadjuvant Chemotherapy Plus Tislelizumab
Patients in this group will receive Tislelizumab consolidation (200 mg/q3w) after the neoadjuvant chemotherapy plus Tislelizumab and concurrent chemoradiotherapy.
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov