The goal of this clinical trial is to learn if tislelizumab in combination with anlotinib and platinum-based doublet chemotherapy works to treat for resectable stage II-IIIB driver gene-negative NSCLC. It will also learn about the safety of tislelizumab in combination with anlotinib and platinum-based doublet chemotherapy.
The main questions it aims to answer are:
1. Does tislelizumab combined with anlotinib and platinum-based doublet perioperative therapy can increase pCR rate as well as MPR rate、EFS、DFS、ORR、OS for resectable stage II-IIIB driver gene-negative NSCLC? 2. Is tislelizumab combined with anlotinib and platinum-based doublet perioperative therapy safe?
Participants with histologically or cytologically confirmed NSCLC, potentially resectable, driver gene negative (II- IIIB stage), and without prior systemic treatment, who have signed the informed consent, will be screened for inclusion. After receiving 4 cycles of tislelizumab combined with anlotinib and platinum-based doublet chemotherapy, the subjects will be evaluated by a multidisciplinary team (MDT) to determine whether to proceed with radical surgical resection. The surgery will be performed within 3 to 7 weeks after the last neoadjuvant treatment. Postoperatively, patients will be divided into two subgroups based on the pathological results: For patients with postoperative pathological pCR, tislelizumab monotherapy will be used for maintenance treatment; For patients with postoperative pathological non-pCR, tislelizumab combined with anlotinib will be used for maintenance treatment. Both groups will continue treatment until disease progression as defined by RECIST 1.1, intolerable toxicity, withdrawal of informed consent, initiation of other anti-tumor therapy, death, or other situations specified in the protocol that require treatment cessation, whichever occurs first. The maximum treatment duration is 12 months. Survival and safety assessments will be continuously conducted thereafter.
Fully understand and voluntarily sign the informed consent for this study;
Age ≥18 years old and ≤75 years old, male or female;
Patients with histologically or cytologically confirmed resectable stage II-IIIB non-small cell lung cancer;
ECOG 0-1;
The pathological types of the patients were mixed with components of small cell lung cancer, neuroendocrine carcinoma, sarcoma, salivary gland tumor and mesenchymal tumor.
Central, caenorrhea squamous cell carcinoma or hemoptysis non-small cell lung cancer (hemoptysis >50 mL/ day);
The tumor is surrounded by large blood vessels, and there is a potential risk of hemoptysis after anlotinib treatment;
Presence of symptomatic or clinically significant thyroid dysfunction at screening (hypothyroidism controlled only with thyroid hormone replacement could be included);
Single group
tislelizumab in combination with anlotinib and platinum-based doublet chemotherapy
DrugAfter receiving 4 cycles of tislelizumab combined with anlotinib and platinum-based doublet chemotherapy, the subjects will be evaluated by a multidisciplinary team (MDT) to determine whether to proceed with radical surgical resection. The surgery will be performed within 3 to 7 weeks after the last neoadjuvant treatment. Postoperatively, patients will be divided into two subgroups based on the pathological results: For patients with postoperative pathological pCR, tislelizumab monotherapy will be used for maintenance treatment; For patients with postoperative pathological non-pCR, tislelizumab combined with anlotinib will be used for maintenance treatment. Both groups will continue treatment until disease progression, intolerable toxicity, withdrawal of informed consent, initiation of other anti-tumor therapy, death, or other situations specified in the protocol that require treatment cessation, whichever occurs first. The maximum treatment duration is 12 months
Pathological Complete Response (pCR) rate
Pathological complete response (pCR) is measured as the percentage of participants with a pathological complete response as assessed by the central pathologist at the time of definitive surgery. pCR is defined as having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes.
Major Pathological Response (mPR) rate
The percentage of participants with a major pathological response (mPR) as assessed by the Central Pathologist at the time of definitive surgery. mPR is defined as ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all the sampled regional lymph nodes.
Event-free Survival (EFS)
EFS is the time from the date of randomization to the date of first record of any of the following events: radiographic disease progression; local or distant progression or recurrence as assessed with imaging or biopsy as indicated; or death due to any cause. Radiographic disease progression during neoadjuvant phase that precludes surgery will be considered an event; a secondary malignancy will not be considered an event.
Disease-free survival (DFS)
defined as the period from the first day after radical surgery (when the disease is confirmed to be cured) to local recurrence or distant metastasis or the time of death for any reason was determined by the investigator during the period of adjuvant therapy and safety follow-up, whichever occurred first.Only patients who underwent R0 resection will be analyzed.
Objective response rate (ORR)
defined as the proportion of all patients with measurable disease at baseline as assessed by the investigator according to RECIST version 1.1 who achieved a complete response (CR) or partial response (PR). The proportion of patients achieving complete remission (CR) or partial remission (PR) among the patients
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