ALK Tyrosine Kinase Inhibitors in ALK-rearranged Advanced Squamous Cell Carcinoma

Exclusion Criteria

• •1. Prior systemic therapy for locally advanced or metastatic disease.
• •2. Subjects who have received any of the following treatments must be excluded:
• •* Treatment with molecules such as EGFR, VEGFR antibodies within 4 weeks prior to the first dose of study drug.
• •* Have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity. Chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may be performed 7 days prior to the first dose.
• •* Ongoing (or inability to discontinue) possibly potent CYP1A2, CYP3A inhibitor (1 week), or inducer (2 weeks) drug therapy or herbal supplements within 1-2 weeks prior to the first dose.
• •3. Presence of spinal cord compression or meningeal metastasis.
• •4. History of other malignant tumors within 2 years.
• •5. Adverse events (except alopecia of any degree) of CTCAE \> grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.
• •6. History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
• •7. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.
• •8. Subjects with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection.
• •9. Heart-related diseases or abnormalities
• •10. Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by immunotherapy.
• •11. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due to previous bowel resection.
• •12. Live vaccine was given 2 weeks before the first medication.
• •13. Women who are breastfeeding or pregnant.
• •14. Hypersensitivity to the test drug and the ingredients.
• •15. Other conditions assessed by the investigator to be unsuitable for participation in the study.