The purpose of this study is to observe and evaluate the efficacy and safety of cadonilimab combined with chemotherapy in patients with resectable IB (≥ 4cm) - IIIB (N2) stage PD-L1 negative non-small cell lung cancer
This study is design to prospectively investigate the safety and efficacy of cadonilimab combined with chemotherapy in patients with resectable IB (≥ 4cm) - IIIB (N2) stage PD-L1 negative NSCLC. This is a single-institution, single-arm phase 2 clinical trial. Patients will receive 3 cycles of neoadjuvant chemotherapy. The surgery was performed 3-6 weeks after the completion of neoadjuvant chemotherapy. After surgery patients could receive up to 12 months of adjuvant chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
PD-1/CTLA-4 bispecific antibody,Cadonilimab 10mg/kg IV, q3w, paclitaxel 175mg/m2 or albumin-bound paclitaxel 260mg/m2 ivgtt d1, q3w carboplatin AUC 5 ivgtt d1, q3w
Sichuan Provincial Tumor Hospital
Chengdu, Sichuan, China
RECRUITINGMajor pathological response (MPR)
MPR is defined as the percentage of residual viable tumour cells (%RVT) in the tumour bed of no more than 10%.
Time frame: At time of surgery
Pathologic complete response (pCR)
pCR is defined as no invasive and no in situ residuals in lung and nodes
Time frame: At time of surgery
Objective response rate (ORR)
ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1
Time frame: Up to 1 year
Event free survival at 24 months (EFS24)
EFS24 is defined as patient outcomes were evaluated at diagnosis and in the subsets of patients achieving event-free status at 24 months from diagnosis.
Time frame: Up to 2 year
Treatment-Emergent Adverse Event (TEAE)
TEAE is defined as any adverse and unexpected change in body structure, function, or chemistry or any exacerbation of an existing condition (i.e., any clinically significant adverse change in frequency and/or intensity) during treatment. The type, frequency, and severity of TEAE will be assessed during treatment.
Time frame: Up to 2 year
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