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
Age ≥ 18 years and ≤ 70 years
Patients with non-small cell lung cancer diagnosed by pathologic histology or cytology, and the primary focus or lymph node metastasis test is clearly negative for EGFR/ALK/ROS1;
Tumor tissue PD-L1 expression TPS <1%
Patients with resectable stage IB (≥4 cm) to IIIB (N2) NSCLC (according to the staging criteria of the American Joint Committee on Cancer, 7th edition)
Patients with large cell carcinoma and mixed cell lung cancer, mixed with small cell lung cancer components;
Presence of locally advanced unresectable or metastatic disease;
Patients in whom imaging shows that the tumor has invaded a vital vascular perimeter or in whom, in the judgment of the investigator, there is a high likelihood that the tumor will invade a vital vessel and cause a fatal hemorrhage during the follow-up study; or patients in whom there is a significant cavitating or necrotic tumor in the lung;
Has undergone any systemic anticancer therapy for NSCLC, including cytotoxic drug therapy, immunologic drug therapy, experimental therapy;
Single group
cadonilimab+paclitaxel/albumin-bound paclitaxel+carboplatin
DrugPD-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
Major pathological response (MPR)
MPR is defined as the percentage of residual viable tumour cells (%RVT) in the tumour bed of no more than 10%.
Pathologic complete response (pCR)
pCR is defined as no invasive and no in situ residuals in lung and nodes
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
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.
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.
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