The advent of immunotherapy has changed the treatment landscape for patients with non-small cell lung cancer. It has become the mainstay of perioperative treatment for patients with resectable non-small cell lung cancer。 Cadonilimab is the world's first bispecific antibody drug targeting PD-1 and CTLA-4. Previous studies on AK104 have demonstrated preliminary efficacy in both treatment-naïve advanced NSCLC patients and immunotherapy-resistant patients, showing a favorable safety and tolerability profile. This study aims to evaluate the effectiveness of neoadjuvant bispecific antibody AK104 compared with neoadjuvant chemotherapy combined with a PD-1 inhibitor in the treatment of resectable non-small cell lung cancer (NSCLC) with high PD-L1 expression.
The advent of immunotherapy has changed the treatment landscape for patients with non-small cell lung cancer. It has become the mainstay of perioperative treatment for patients with resectable non-small cell lung cancer。 Cadonilimab is the world's first bispecific antibody drug targeting PD-1 and CTLA-4. Previous studies on AK104 have demonstrated preliminary efficacy in both treatment-naïve advanced NSCLC patients and immunotherapy-resistant patients, showing a favorable safety and tolerability profile. This study aims to evaluate the effectiveness of neoadjuvant bispecific antibody AK104 compared with neoadjuvant chemotherapy combined with a PD-1 inhibitor in the treatment of resectable non-small cell lung cancer (NSCLC) with high PD-L1 expression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Eligible patients will be randomly assigned in a 1:1 ratio to either the PD-1 combined with chemotherapy group or the AK104 monotherapy group. Treatment will be administered every 3 weeks, with patients undergoing three preoperative treatment cycles before surgery.
PCR
a complete absence of viable tumor cells in the primary tumor site and surgically removed lymph nodes after neoadjuvant treatment
Time frame: up to 60 months
MPR
≤10% residual viable tumor cells in the lung and sampled lymph nodes
Time frame: up to 60 months
ORR
a partial or complete response according to RECIST, version 1.1
Time frame: up to 60 months
OS
the time from randomization to death from any cause
Time frame: up to 60 months
EFS
the time from randomization to progression of disease, recurrence of disease, or death from any cause.
Time frame: up to 60 months
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Incidence of serious adverse events (SAEs) occurring during treatment according to NCI-CTCAE v5.0
Time frame: up to 60 months
R0 rate
Proportion of patients achieving R0 resection
Time frame: up to 60 months
Conversion rate of surgery
Conversion rate from initially unresectable to resectable NSCLC following neoadjuvant therapy
Time frame: up to 60 months
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