Lung Cancer (NSCLC)
Conditions
Keywords
Unresectable Locally Advanced Non-Small Cell Lung Cancer, Induction Chemoimmunotherapy, Hypofractionated Concurrent Chemoradiotherapy, Tislelizumab
Brief summary
This is a prospective, randomized phase II study evaluating concurrent chemoradiotherapy combined with full-course immunotherapy or consolidative immunotherapy in patients with unresectable, locally advanced non-small cell lung cancer.
Detailed description
This is a prospective, randomized phase II study evaluating concurrent chemoradiotherapy combined with full-course immunotherapy or consolidative immunotherapy in unresectable, locally advanced non-small cell lung cancer. Patients are randomized in a 1:1 ratio to experimental group and control group. The experimental group will receive induction chemoimmunotherapy, concurrent chemoradiotherapy, and full-course immunotherapy during the chemoradiotherapy phase and consolidation phase. Patients in the control group will receive concurrent chemoradiotherapy and consolidative immunotherapy.
Interventions
Nab-paclitaxel 260 mg/m² + cisplatin 75 mg/m² + tislelizumab 200 mg on day 1, Q3W，3 cycles.
RADIATIONradiotherapy
Thoracic radiotherapy at a definitive dose using intensity-modulated radiation therapy or Volumetric Modulated Arc Therapy.
DRUGConcurrent Chemotherapy
Nab-paclitaxel 50 mg/m² + cisplatin 25 mg/m² on day 1, weekly.
Tislelizumab 200 mg on day 1, every 3 weeks.
DRUGfull-course immunotherapy
Immunotherapy (Tislelizumab 200 mg d1) will be administered during the concurrent chemoradiotherapy phase and consolidation phase, but not on radiotherapy days.
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
* Male or female patients aged 18-75 years ; * Histologically or cytologically confirmed, locally advanced, unresectable stage III non-small cell lung cancer (NSCLC); * Wild-type EGFR, ALK, and ROS1; * No prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy; * Availability of unstained archival tumor tissue samples sufficient for analysis; * Life expectancy of ≥12 weeks; * World Health Organization (WHO) performance status of 0 or 1; * Female patients must not be breastfeeding; * Adequate organ and bone marrow function, meeting all of the following criteria: Forced expiratory volume in 1 second (FEV1) ≥800 mL; Absolute neutrophil count ≥1.5 × 10⁹/L; Platelet count ≥100 × 10⁹/L; Hemoglobin ≥9.0 g/dL; Creatinine clearance ≥50 mL/min, calculated using the Cockcroft-Gault formula (Cockcroft and Gault, 1976); Serum bilirubin ≤1.5 times the upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times ULN.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival rate | 18 months | From the first day of treatment to the day of progression or the day of death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 18 months | It was calculated from the first day of treatment to the day of death. |
| Objective response rate | 1 year | The proportion of patients evaluated as CR or PR |
| Incidence of Treatment-related Adverse Events | 1 year | Adverse effects are graded according to the CTCAE 5.0 version. |
Countries
China
Contacts
CONTACTDaQuan Wang
CONTACTHui Liu
PRINCIPAL_INVESTIGATORHui Liu
Sun Yat-Sen University Cancer Center
Outcome results
None listed