Evaluation of the efficacy of KN046 combined with acitinib as a neoadjuvant therapy for resectable NSCLC through primary pathological response rate and surgical resection rate
The purpose of this study is to evaluate the rate of major pathological remission (MPR) with preoperative use of KN046 versus axitinib, and thus to assess the efficacy of KN046 in combination with axitinib in patients with Stage IB-IIIB (Stage IIIB only T3N2M0) NSCLC (according to the 8th edition of the AJCC classification) who are scheduled to undergo surgery. Eligible subjects for this study were candidates for surgery for resectable stage IB-IIIB (stage IIIB only T3N2M0) NSCLC as judged by the investigator, with no evidence of distant metastases as assessed, and no evidence of unresectable local regional tumour extension.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
KN046 combined with axitinib as a neoadjuvant treatment regimen
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
RECRUITINGShanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGMPR
MPR is defined as the presence of ≤ 10% of active tumor cells in postoperative pathology (primary lesion).
Time frame: one month within postsurgery
Surgical resection rate
Surgical resection rate: refers to the proportion of subjects who completed the surgery according to the plan, defined as the distance from the last neoadjuvant treatment administration, and the surgical time ≤ 6 weeks.
Time frame: six weeks after last cycle of neoadjuvant therapy
Complication rate
The incidence and severity of AE (classified according to CTCAE v5.0), severity, and their relationship with experimental treatment; Any abnormal results of laboratory tests, vital signs, and physical examinations;
Time frame: three months within postsurgery
pCR
PCR is defined as postoperative pathology (primary lesion) showing the absence of viable tumor cells
Time frame: one month within postsurgery
ORR
Defined as the proportion of subjects who achieved complete remission (CR) or partial remission (PR) according to RECIST 1.1
Time frame: one month within postsurgery
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