Non-small Cell Lung Cancer
Conditions
Brief 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.
Detailed description
This prospective interventional clinical study aims to evaluate the efficacy and safety of third-generation EGFR-TKI combined with anlotinib as maintenance therapy following 4-6 cycles of chemotherapy and immunotherapy in patients with advanced NSCLC who developed small cell transformation after EGFR-TKI resistance.Approximately 30 non-small cell lung cancer patients who developed small cell transformation after EGFR-TKI resistance were enrolled and treated with 4-6 cycles of chemotherapy plus immunotherapy followed by maintenance therapy with third-generation EGFR-TKI combined with anlotinib.The study is expected to commence recruitment in mainland China in about November 2024. It is expected that the trial will end in December 2026.
Interventions
DRUGthird-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.
Sponsors
Hunan Province Tumor Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Time from standard chemotherapy plus immunotherapy to study completion, or up to 36 month | To assess overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as the proportion of subjects who have a complete response (CR) or a partial response (PR) |
| Adverse events (AEs) according to CTCAE 5.0 | Time from standard chemotherapy plus immunotherapy to study completion, or up to 36 month | Number of participants with adverse events (AEs) according to CTCAE 5.0 |
Countries
China
Contacts
Primary ContactYongchang Zhang
Backup ContactLiang Zeng
Outcome results
None listed