third-generation EGFR-TKI combined with anlotinib: third-generation EGFR-TKI combined with anlotinib as maintenance therapy following 4 to 6 cycles of chemotherapy and immunotherapy until progressive disease.
Study summary
This study aimed to evaluate the efficacy and safety of third-generation EGFR-TKI plus anlotinib as maintenance after chemotherapy plus immunotherapy in advanced NSCLC with small cell transformation after EGFR-TKI resistance.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
progression-free survival (PFS) — Time from standard chemotherapy plus immunotherapy to study completion, or up to 36 month PFS was defined as the duration from the start of standard chemotherapy plus immunotherapy to disease progression or last follow up
Trial sites (1)
Facility
City
Region
Status
Yongchang Zhang
Changsha
Hunan
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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