NSCLC (Non-small Cell Lung Cancer)
Conditions
Brief summary
This phase II trial employs a prospective, randomized, parallel-group design to evaluate the efficacy and safety of hypofractionated radiotherapy combined with tislelizumab and surufatinib. Eligible patients are randomly assigned to one of two arms: Experimental Group A receives hypofractionated chemoradiotherapy plus concurrent tislelizumab and surufatinib, followed by consolidation therapy with tislelizumab plus surufatinib; Experimental Group B receives the same hypofractionated chemoradiotherapy plus concurrent tislelizumab alone, followed by tislelizumab consolidation.
Interventions
RADIATIONRadiotherapy
Split-course hypofractionated thoracic radiotherapy
DRUGConcurrent chemotherapy
Weekly nab-paclitaxel and cisplatin during radiotherapy
DRUGTislelizumab
Tislelizumab 200mg every three weeks during and following radiotherapy
DRUGSurufatinib
Surufatinib during and following radiotherapy
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Males or females aged 18 to 75 years or older; * Patients must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC); * Unresectable Stage III disease according to AJCC 8th staging system; * Negative for known driver gene mutations； * Newly diagnosed patients or patients treated with ≤ 4 cycles of chemotherapy combined with or without immunotherapy; * Expected survival ≥ 12 weeks; * WHO Performance Status (PS) score of 0 or 1; * Female subjects must not be breastfeeding; * Women of childbearing potential (WOCBP) must agree to use contraception during the study treatment and for 5 months after the last dose of study drug (i.e., 30 days \[one ovulation cycle\] plus approximately five half-lives of the study drug); * Adequate organ and bone marrow function as defined by the following criteria: * Forced Expiratory Volume in 1 second (FEV1) ≥ 800 mL; * Absolute neutrophil count ≥ 1.5 × 10⁹/L; * Platelets ≥ 100 × 10⁹/L; * Hemoglobin ≥ 9.0 g/dL; * Creatinine clearance ≥ 50 mL/min as calculated by the Cockcroft-Gault formula (Cockcroft and Gault, 1976); * Serum bilirubin ≤ 1.5 × upper limit of normal (ULN); * AST and ALT ≤ 2.5 × ULN.
Exclusion criteria
* 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; * Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access; * Active or prior documented autoimmune disease within the past 2 years; * Active or prior documented inflammatory bowel disease (eg. Crohn's disease, ulcerative colitis); * History of primary immunodeficiency; * History of organ transplant that requires therapeutic immunosuppression; * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent; * Known history of tuberculosis; * History of another primary malignancy within 5 years prior to starting treatment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study; * Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 18-month | The time from randomization to the first documented disease progression or death from any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 18-month | The time from randomization to death from any cause, censored at the last follow-up date. |
| Treatment related toxicity | 18-month | Graded by CTCAE 5.0 |
Countries
China
Contacts
CONTACTDaQuan Wang, MD
Outcome results
None listed