Lung Cancer (NSCLC)
Conditions
Brief summary
This study will enroll patients with locally advanced non-small cell lung cancer (NSCLC). Patients will receive neoadjuvant chemotherapy combined with dual immune checkpoint blockade (PD-1/CTLA-4), bevacizumab and thymosin alpha 1, followed by concurrent chemoradiotherapy, and finally consolidation therapy with dual immune checkpoint blockade (PD-1/CTLA-4), surufatinib and thymosin alpha 1. The study aims to evaluate the efficacy and safety of this treatment regimen.
Interventions
DRUGNeoadjuvant therapy
The neoadjuvant regimen prior to radiotherapy consists of albumin-bound paclitaxel/pemetrexed, cisplatin, Bevacizumab, iparomlimab and tuvonralimab, and thymosin alpha 1.
RADIATIONRadiotherapy
Definitive dose of hypofractionated radiotherapy was delivered to patients, with concurrent chemotherapy and surufatinib.
Consolidation therapy consists of iparomlimab and tuvonralimab, surufatinib and thymosin alpha 1, for a total duration of 1 year.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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 locally advanced, unresectable (Stage III) non-small cell lung cancer (NSCLC); * EGFR, ALK, and ROS1 wild-type; * No prior chemotherapy, radiotherapy, surgery, targeted therapy, or 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
1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 2-year | PFS measures the time from the start date of treatment to disease progression, death from any cause or last follow up if alive. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 2-year | OS measures the time from the start date of treatment to death from any cause or last follow up if alive. |
| Objective response rate | 2 month after treatment | — |
| Treatment-related toxicity | through study completion, an average of 18 months | Treatment-related toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) 5.0 toxicity |
Countries
China
Contacts
Primary ContactDaQuan Wang, MD.
Outcome results
None listed