Third-generation EGFR-TKI Plus Anlotinib as Maintenance for NSCLC With Small Cell Transformation … (NCT06634667) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Third-generation EGFR-TKI Plus Anlotinib as Maintenance for NSCLC With Small Cell Transformation After EGFR-TKI Resistance
China30 participantsStarted 2024-11-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 gas…
What they're measuring
1
progression-free survival (PFS)
Timeframe: Time from standard chemotherapy plus immunotherapy to study completion, or up to 36 month