This study is a single-arm prospective clinical trial. The primary objective of the study is to explore the efficacy and safety of preoperative neoadjuvant therapy with Tislelizumab combined with Anlotinib and Nab-Paclitaxel in resectable stage III non-small cell lung cancer.Finally, it provides new evidence-based medical evidence for the perioperative treatment of non-small cell lung cancer.
Age 18-75 years old, gender is not limited;
Histologically confirmed Stage III non-small cell lung cancer (AJCC Stage 8th edition)
The tumor is resectable after assessment by the attending surgeon
EGFR/ALK mutation negative or unknown (unknown only for squamous non-small cell lung cancer)
A history of received treatment for current lung cancer, including radiotherapy and all systemic antitumor agents, including chemotherapy, immunotherapy, targeted therapy or antiangiogenic therapy.
Patients with known EGFR gene mutation, ALK rearrangement, ROS-1 fusion, RET fusion, HER-2 mutation, MET mutation, but if patients with squamous non-small cell lung cancer, the EGFR mutation status and ALK mutation status are unknown, it is not required to conduct tests during screening
There are multiple factors influencing patients taking oral medication (such as inability to swallow, chronic diarrhea, intestinal obstruction)
Allergy to any study drug (Tislelizumab, Anlotinib, albumin-bound Paclitaxel) or excipients.
Single group
neoadjuvant therapy
Drugtislelizumab （200mg，iv, q3w） + Anlotinib （10mg, orally, D1-14, q3w）+nab-paclitaxel（260mg/m2，q3w）3-4cycle
Surgery
Procedure/SurgerySurgery should be performed 4 to 6 weeks after the last neoadjuvant therapy (at least 4 weeks after the end of anlotinib treatment).
Adjuvant therapy
DrugTislelizumab: 200mg, iv, Q3W, 1year at most(including preoperative treatment medication, a total of 17 cycles).
pathological complete response (pCR)
pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
Major Pathological Response (mPR) Rate
mPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.
R0 resection rate
R0 Resection Rate: The pathological results will showed that the incision margin was negative and no residual cancer cells were found under the microscope.
Event-Free Survival(EFS)
The time from the start of randomization (or the start of treatment in a one-arm trial) to the first occurrence of any of the following events: disease progression without surgical treatment, local or distant recurrence, death from any cause, etc.
overall survival(OS)
Time from randomization to death (from any cause)
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