Table 1.

Study Inclusion and Exclusion Criteria.

Inclusion criteria

Exclusion criteria

1. Pathologically and/or cytologically diagnosed with IIIB–IVB NSCLC according to AJCC Cancer Staging Manual (8th edition).22 2. Patients without driver gene mutations who have received at least first-line systemic chemotherapy (immune checkpoint inhibitors or anti-vascular drug therapy) and developed disease progression, relapse, or intolerance 3. Patients with driver gene mutations (EGFR mutation or ALK fusion-positive) who have developed disease progression, relapse, or intolerance after receiving the corresponding standard targeted drug therapy 4. Men or women aged 18 to 75 y 5. ECOG PS score of 0 to 2 and Expected survival time ≥24 wk 6. Measurable lesion based on RECIST v 1.123 7. Adequate liver and kidney function (Cr ≥ 60 mL/min; TB ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN); 8. Hb ≥ 100 g/L; NEU ≥ 1.5 × 109/L; PLT ≥ 100 × 109/L 9. Agree to use contraception during the trial and for 6 mo thereafter 10. Informed consent provided by the patient or family member.

1. Unstable brain metastases or bleeding risk 2. Previously used anlotinib or apatinib 3. Other types of concurrent malignant tumors 4. Unable to take oral medications due to dysphagia, chronic diarrhea, or intestinal obstruction 5. Pregnant or breastfeeding women 6. Mental illness or intellectual disability 7. Allergic to or intolerant of the study drug

Abbreviations: AJCC, American Joint Committee on Cancer; NSCLC, non-small-cell lung cancer; EGFR, epidermal growth factor receptor; ALK, anaplastic lymphoma kinase; ECOG PS, Eastern Cooperative Oncology Group performance status; RECIST, Response Evaluation Criteria in Solid Tumors; Cr, creatinine clearance rate; ALT, alanine aminotransferase; AST, aspartate aminotransferase; TB, total bilirubin; Hb, hemoglobin; NEU, neutrophils; PLT, platelet; hCG, human chorionic gonadotropin