This study is a randomized, open-label Phase 2 study to compare the efficacy and safety of IBI363 Combined with Chemotherapy or Pembrolizumab Combined with Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer.
Males and Females, age ≥18 years and ≤75 years;
Stage IB, II, IIIA or IIIB (N2) NSCLC (per AJCC8);
No administration of any anti-NSCLC therapy in the pre-operative period;
Be able to undergo the radical resection; Pulmonary function capacity capable of tolerating the proposed lung resection according to the surgeon.
Histologically confirmed the presence of small cell lung cancer, neuroendocrine carcinoma, sarcoma, salivary gland tumor, and mesenchymal tumor components, or mixed NSCLC with predominant squamous cell carcinoma features;
Tumor invasion of surrounding important structures, which is symptomatic or medical intervention indicated;
Pancoast tumor;
Malignant tumor nodule in the contralateral lung lobe;
Parallel
Pemetrexed
Drug500 mg/m2 D1 IV Q3W
Cisplatin
Drug75 mg/m2 D1 IV Q3W
IBI363
Drug1.5 mg/kg D1 IV Q3W
Carboplatin
DrugAUC 5 mg/ml/min D1 IV Q3W
Keytruda
Drug200mg D1 IV Q3W
Pathologic Complete Response (pCR) rate
pCR rate is defined as no residual invasive viable tumor in both the primary tumor (lung) and the sampled lymph nodes after neoadjuvant therapy.
Safety parameters: the incidence of all adverse events (AEs)
Safety parameters: the incidence of treatment-emergent adverse events (TEAEs)
Safety parameters: the incidence of immune-related adverse events (irAEs)
Event Free Survival (EFS)
EFS is defined as the time from the first dose to the first determination by the investigator with RECIST v1.1 of inoperable disease progression, postoperative local recurrence or distant metastasis, development of another primary tumor, or death from any cause, whichever occurred first.
Major Pathological Response (mPR) Rate
mPR rate is defined as ≤ 10% residual invasive viable tumor in both the primary tumor (lung) and the sampled lymph nodes after neoadjuvant therapy.
Objective Response Rate （ORR）Rate
ORR is defined as the proportion of subjects assessed by the investigators as achieving complete response (CR) or partial response (PR) according to the RECIST v1.1 criteria.
Disease Control Rate (DCR) Rate
ORR is defined as the proportion of subjects assessed by the investigators as achieving complete response (CR) 、partial response (PR) or stable Disease（SD） according to the RECIST v1.1 criteria.
Click on the lead sponsor to view all of their trials.
