Lung cancer and Pulmonary Tuberculosis
Conditions
Interventions
Trial Group: Tislelizumab plus Anlotinib
Sponsors
Fujian Fuzhou Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients voluntarily participate in this clinical study, sign informed consent forms, demonstrate good compliance, and are able to complete follow-up. 2.Age >=18 years, regardless of gender. 3.Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC). Definition of locally advanced or metastatic disease: Stage IIIB or higher according to the 8th edition of International Association for the Study of Lung Cancer (IASLC) TNM staging system, and not suitable for radical surgery or radiotherapy. 4.Confirmed negative for EGFR, ALK, and ROS1 mutations by genetic testing. 5.No prior systemic therapy for recurrent or metastatic disease; previous neoadjuvant or adjuvant chemotherapy is allowed if the interval between completion of therapy and recurrence or metastasis is =6 months. 6.Confirmed active pulmonary tuberculosis. Definition of active pulmonary tuberculosis: According to the Primary Care Guidelines for Pulmonary Tuberculosis (2018). 7.Expected survival >=12 weeks. 8.Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1. 9.At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (previously irradiated lesions can be considered measurable only if progression has been demonstrated). 10.Adequate organ function meeting the following criteria: 1)Complete blood count (no blood transfusion or G-CSF within 2 weeks prior to screening): a) Hemoglobin (Hb) >=90 g/L b) Absolute neutrophil count (ANC) >=1.5×10^9/L c) Platelet count (PLT) >=90×10^9/L d) White blood cell count (WBC) >=3.0×10^9/L 2)Other laboratory requirements (no albumin infusion within 14 days prior to screening): e) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =60mL/min (calculated by Cockcroft-Gault formula) h) QTc interval =50% 11.Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment and agree to use adequate contraception during the study and for 8 weeks after the last dose of study drug; male patients must be surgically sterile or agree to use adequate contraception during the study and for 8 weeks after the last dose of study drug.
Exclusion criteria
Exclusion criteria: 1.Radiologically confirmed tumor invasion or unclear margins with major vessels. 2.Radiologically confirmed significant cavitary or necrotic pulmonary lesions. Peripheral lesions with cavitation may be considered eligible. 3.Prior therapy for brain or leptomeningeal metastases (radiotherapy or surgery) is permitted if: documented radiological stability for >=4 weeks prior to randomization, systemic corticosteroids discontinued or reduced to 4 weeks, and absence of clinical symptoms. 4.Evidence of leptomeningeal carcinomatosis, spinal cord compression, or pulmonary lymphangitic carcinomatosis. 5.Symptomatic effusions (pleural, pericardial, or peritoneal) requiring drainage, or therapeutic drainage within 2 weeks prior to randomization. 6.History or concurrent malignancy, except for adequately treated: basal cell carcinoma of skin, superficial bladder cancer, squamous cell carcinoma of skin, cervical carcinoma in situ, or other carcinoma in situ with complete remission for >=5 years prior to screening and no anticipated need for treatment during study period. 7.Unresolved toxicity >CTCAE grade 1 from previous therapy at study initiation, excluding alopecia and grade 2 chemotherapy-induced peripheral neuropathy. 8.Severe cardiac, hepatic, or renal disease; neurological or psychiatric disorders; or active severe infections. 9.Intractable nausea/vomiting, chronic gastrointestinal conditions, inability to swallow oral medications, or extensive bowel resection potentially affecting drug absorption. 10.Prior exposure to anlotinib or other VEGFR-TKIs and PD-1/PD-L1 inhibitors. 11.Uncontrolled hypertension despite antihypertensive therapy (systolic BP >140 mmHg or diastolic BP >90 mmHg). 12.Proteinuria =++ on urinalysis with confirmed 24-hour urinary protein >1.0g. 13.Coagulopathy (INR >1.5 or PT >ULN+4 seconds or APTT >1.5 ULN), active bleeding diathesis, or current thrombolytic/anticoagulation therapy. 14.Clinically significant bleeding events or hemorrhagic diathesis within 3 months prior to randomization, including gastrointestinal hemorrhage, hemorrhagic gastric ulcer, fecal occult blood =++, or vasculitis. 15.Arterial or venous thromboembolic events within 6 months prior to randomization, including cerebrovascular events (TIA, cerebral hemorrhage, cerebral infarction), DVT, or pulmonary embolism. 16.History of interstitial lung disease, drug-induced pneumonitis, steroid-requiring radiation pneumonitis, or any evidence of active interstitial lung disease. 17.Active autoimmune disease including but not limited to systemic lupus erythematosus, ulcerative colitis, or autoimmune hemolytic anemia. 18.Known hypersensitivity to anlotinib, tislelizumab, or their excipients. 19.Pregnancy or lactation. 20.Any condition that, in the investigator's judgment, would compromise patient safety or study assessments.Anticipated poor compliance with study procedures, restrictions, or requirements as assessed by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival;Objective response rate;Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate; | — |
Countries
China
Contacts
Public ContactZheng Xiuxia
Fujian Fuzhou Pulmonary Hospital
Outcome results
None listed