Phase II Study on Sintilimab Combined With Docetaxel for Chemotherapy Failure Advanced NSCLC: the SUCCESS Study

Inclusion Criteria:

• Sign written informed consent before any trial-related processes are implemented
• Age ≥ 18 years old and ≤ 75 years old
• Life expectancy exceeds 3 months
• The investigator confirmed at least one measurable lesion according to the RECIST 1.1standard
• Histological or cytological diagnosis of NSCLC and stage IIIB/IV stage tumors (according to the International Association for the Study of Lung Cancer)Chest tumorstaging manual 8th edition judgment) or in multimodal treatment (radiotherapy,surgical resection or radical chemoradiotherapy local treatment)Subjects with relapseor disease progression after treatment for locally advanced disease.
• Subjects must have previously been treated with a platinum-containing dualchemotherapy (carboplatin or cisplatin) regimen for advanced or metastatictumorsisease progression occurred during or after the period. i) receiving maintenance therapy (referring to treatment with no progress aftertreatment with a platinum-containing dual chemotherapy regimen) and progress Subjectsare eligible for inclusion. Ii) treatment of locally advanced disease withplatinum-containing adjuvant, neoadjuvant therapy or radical chemoradiotherapy, andcompletion of treatment Subjects with tumor recurrence or metastasis within 6 monthsafter treatment are eligible.selected. Iii) administration of platinum-containing adjuvant, neoadjuvant therapy or radicalchemoradiotherapy for treatment of locally advanced disease >6 months laterTumorrecurrence, and later progressed during or after treatment of a recurrent tumor with aplatinum-based regimen Subjects are eligible for inclusion.
• Patients confirmed by histological specimens who are not eligible for EGFR, ALK orROS1 targeted therapy (with no tumor) EGFR-sensitive mutations and no evidence of ALK,ROS1 gene rearrangement);
• The Eastern Cancer Cooperative Group (ECOG) has a fitness status score of 0 or 1
• Good hematopoietic function, defined as absolute neutrophil count ≥1.5×109/L, plateletcount ≥100×109/L, hemoglobin≥90g/L [no blood transfusion or erythropoietin (EPO)within 7 days] Dependency];
• Good liver function, defined as total bilirubin level ≤ normal upper limit (ULN);patients without liver metastases, Aspartate aminotransferase (AST) and alanineaminotransferase (ALT) levels ≤ 1.5 times ULN, alkaline phosphatase ≤ 2.5 times ULNFor patients with recorded liver metastases, AST and ALT levels ≤ 5 times ULN;

Exclusion Criteria:

• Small cell lung cancer
• Currently participating in interventional clinical research treatment, or receivingother research medications within 4 weeks prior to the first dose or Used researchequipment;
• Previously received the following treatments: anti-PD-1, anti-PD-L1 or anti-PD-L2drugs or for another stimulus or association a drug that inhibits T cell receptors (eg, CTLA-4, OX-40, CD137);
• Systemic systemic treatment of Chinese patent medicines or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use of pleuraleffusion) with anti-lung cancer indications within 2 weeks prior to the first dose, orbefore the first dose Major surgical treatment within 3 weeks;
• Pulmonary radiation therapy >30 Gy within 6 months prior to first dose
• Completed palliative radiotherapy within 7 days prior to the first dose