Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-01-07 @ 7:16 AM
Study NCT ID:
NCT06634667
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-10
First Post:
2024-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Third-generation EGFR-TKI Plus Anlotinib as Maintenance for NSCLC With Small Cell Transformation After EGFR-TKI Resistance
Sponsor:
Hunan Province Tumor Hospital
Organization:
Study Overview
Official Title:
Efficacy and Safety of Third-generation EGFR-TKI Combined With Anlotinib as Maintenance Therapy Following 4-6 Cycles of Chemotherapy and Immunotherapy in NSCLC With Small Cell Transformation After EGFR-TKI Resistance: a Single-arm Prospective Phase II Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: