This is a prospective single-center, open-label, phase II study evaluating the efficacy of sintilimab plus anlotinib as a neoadjuvant regimen in the treatment of IB-IIIB resectable non-small cell lung cancer.
Providing written informed consent prior to initiating the study.
Regardless of sex, aged ≥18 years and ≤75 years.
Histologically confirmed NSCLC.
At least one radiologically measureable lesion according to response evaluation criteria in solid tumors version 1.1(RECIST V1.1).
Other malignancy rather than NSCLC diagnosed within 5 years prior to the first dose of the study given, except for definitively treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or in situ carcinoma.
Enrolled in an ongoing interventional clinical trial, or receiving other study drugs or study medical devices within 4 weeks prior to the first dose of this study drugs.
A history of receiving the following therapies: anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death ligand-1 (anti-PD-L1) or anti-programmed cell death ligand-2 (anti-PD-L2) drugs, or drugs targeting T cell receptor (such as cytotoxic T-lymphocyte-associated protein 4, tumor necrosis factor receptor superfamily member 4 and CD137).
A history of receiving targeted therapy such as anti-vascular endothelial growth receptor (VEGR)/ vascular endothelial growth factor receptor (VEGFR), rapidly accelerated fibrosarcoma(RAF), mitogen-activated protein kinase(MAPK), platelet-derived growth factor Receptor(PDGFR) or fibroblast growth factor receptor(FGFR).
Single group
Sintilimab
Drug200mg, every 3 weeks, 3 cycles, in the neoadjuvant setting, and adjuvant 200mg,every 3 weeks no more than one year
Anlotinib
Drug8mg, orally, D1-14, every 3 weeks, 2 cycles in only neoadjuvant setting
major pathological response (MPR)
Viable tumor cells are no more than 10% in the resected specimen
pathological complete response (pCR)
Viable tumor cells are not found in the resected specimen
treatment-related adverse events (TRAEs)
TRAEs including immune-related adverse reaction are documented and graded based on the US National Cancer Institute's Common Terminology Criteria for Adverse Events 5.0 criteria.
disease-free survival (DFS)
DFS is defined as the duration between the date of surgery and the date on which tumor recurrence is confirmed
rate of operative complications
The rate of surgical complications (such as bleeding, bronchopleural fistula,ect) are recorded and graded according to Clavien-Dindo criteria
minimal residual disease (MRD)
MRD is evaluated by testing circulating tumor DNA (ctDNA) in peripheral blood sample using next-generation sequencing(NGS) method. Each participant will undergo a minium of 3 tests for MRD.
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