This is a randomized, open-label, multicenter phase II study. The trial plans to enroll 164 subjects with resectable stage IIA-IIIB (N2) NSCLC. Participants will be randomized 1:1 into either the ivonescimab plus chemotherapy or penpulimab plus chemotherapy treatment arm. After 3-4 cycles of neoadjuvant therapy, surgical resection will be performed. The primary objective is to compare the pathological complete response (pCR) rate assessed by local pathologists between ivonescimab-based and penpulimab-based chemo-immunotherapy regimens in the neoadjuvant treatment of resectable NSCLC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
164
Ivonescimab (AK112) + platinum-based doublet chemotherapy
Penpulimab (AK105) + platinum-based doublet chemotherapy
Peking University People's Hospital
Beijing, Beijing Municipality, China
Hunan Cancer Hospital
Changsha, Hunan, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Pathologic Complete Response (pCR) Rate
Pathologic complete response (pCR) rate is defined as the percentage of participants with no residual viable tumor in lung primary or lymph nodes as evaluated by systematic pathological review of surgical specimens.
Time frame: Within 1 month after surgery
Major Pathologic Response (MPR) Rate
Major pathologic response (MPR) rate is defined as the percentage of participants with less than 10% of residual viable tumor in lung primary or lymph nodes as evaluated by systematic pathological review of surgical specimens. Viable tumors in situ carcinoma should not be included in MPR calculation.
Time frame: Within 1 month after surgery
Event-Free Survival (EFS)
Defined as the time from the first dose to the occurrence of any of the following events (whichever occurs first), assessed in the Intention-To-Treat (ITT) population: Disease progression (based on RECIST v1.1 criteria by investigators); Local recurrence or distant metastasis; Death from any cause
Time frame: the time from the first dose to the occurrence of any of the following events (whichever occurs first), assessed in the Intention-To-Treat (ITT) population: Disease progression (based on RECIST v1.1 criteria by investigators); Local recurrence or dist
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