Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT06634667
Eligibility Criteria:
Inclusion Criteria:
* 1\. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
* 2\. Age ≥ 18 years.
* 3\. Histopathology is confirmed non-small cell lung cancer .
* 4.Patients with advanced non-small cell lung cancer (NSCLC) who experienced small cell transformation after EGFR-TKI resistance.
* 5\. Predicted survival ≥ 12 weeks. .
* 6\. ECOG 0-2.
* 7\. Adequate bone marrow hematopoiesis and organ function.
Exclusion Criteria:
* 1\. History of other malignant tumors within 2 years.
* 2\. 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.
* 3\. History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
* 4\. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.
* 5\. 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.
* 6\. Heart-related diseases or abnormalities
* 7\. 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.
* 8\. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due to previous bowel resection.
* 9\. Live vaccine was given 2 weeks before the first medication.
* 10\. Women who are breastfeeding or pregnant.
* 11\. Hypersensitivity to the test drug and the ingredients.
* 12\. Other conditions assessed by the investigator to be unsuitable for participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06634667
Study Brief:
Protocol Section:
NCT06634667