This study is a prospective, multicenter, open-label, single-arm Phase II clinical trial. The study recruits patients with stage III unresectable non-small cell lung cancer according to the 8th edition of the AJCC/UICC staging system. It aims to observe and evaluate the efficacy and safety of anti-PD-1/CTLA-4 antibody in combination with paclitaxel polymer micelles and platinum-based therapy for stage III unresectable non-small cell lung cancer.
This study includes a screening period (the maximum time interval from screening to the start of treatment ≤21 days), a treatment period (including the induction therapy phase, local therapy phase \[surgery or radiotherapy\], and consolidation therapy phase), and a follow-up period (including safety follow-up and survival follow-up). The primary endpoint is the objective response rate after induction therapy. Secondary endpoints include the pathological complete response rate in operable patients, major pathological response rate, surgical conversion rate, R0 resection rate, and 18-month event-free survival rate, among others.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
The induction therapy regimen is as follows: Apalotamab: 5 mg/kg, every 3 weeks (q3w), administered via intravenous infusion. Paclitaxel polymer micelles in combination with platinum: In cycle 1, paclitaxel polymer micelles 230 mg/m² administered via intravenous infusion over ≥3 hours, with the option to escalate the dose in cycle 2 according to the instructions for use, followed by cisplatin 70 mg/m² or carboplatin AUC 5 mg/mL/min. The local treatment regimen involves re-evaluation by a multidisciplinary team (MDT), surgery, or radical radiotherapy or single fractionated segmental radiotherapy (two radiotherapy regimens for the investigator to choose from). The consolidation therapy regimen consists of apalotamab consolidation for 1 year or up to a maximum of 17 cycles, with the decision to combine with chemotherapy left to the discretion of the treating physician on an individual basis.
Jiangsu Provincial Cancer Hospital
Nanjing, China
RECRUITINGObjective response rate ,ORR
Time frame: Approximately four months
Pathological complete remission rate, pCR
Time frame: Approximately four months
Major pathological response rate , MPR
Time frame: Approximately four months
Surgical conversion rate, SCR
Time frame: Approximately four months
R0 resection rate
Time frame: Approximately four months
18-month event-free survival rate
Time frame: 18-month
Event Free Survival,EFS
Time frame: up to 5 years after treatment discontinuation
Overall survival ,OS
Time frame: up to 5 years after treatment discontinuation
Safety
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: From ICF through 100 days after the last dose of study treatment
PD-L1 expression
Time frame: Within 3 years
Tumor mutation burden (TMB)
Time frame: Within 3 years
Next-generation sequencing (NGS), and chemotherapy drug sensitivity analysis
First, use NGS to identify the molecular characteristics of the tumor, and then infer or experimentally verify its sensitivity to specific chemotherapeutic drugs based on these characteristics, thereby achieving precision medicine in clinical practice or research.
Time frame: Within 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.