Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07482605
Brief Summary:
This study aims to prospectively and multi-centrally explore the efficacy and safety of furmonertinib combined with upfront thoracic radiotherapy in treating NSCLC participants with EGFR mutations and malignant pleural effusion, thereby providing more evidence-based medical evidence for improved diagnosis and treatment of NSCLC-MPE participants . Additionally, NGS testing of ctDNA from peripheral blood will be performed before the first furmonertinib treatment, before the first thoracic radiotherapy and after its completion, and after disease progression. This will help identify individuals who benefit from this treatment modality and investigate new resistance mechanisms to furmonertinib under the radiotherapy plus TKI combination model, ultimately serving participants better.
Detailed Description:
This study plans to prospectively and multi-centrally enroll 63 participants with stage IVA non-small cell lung adenocarcinoma harboring EGFR-sensitive mutations (exon 19 deletion, exon 21 L858R mutation) and malignant pleural effusions (MPE). After initial treatment with 2 months of furmonertinib ± thoracentesis and drainage, leading to good control of malignant pleural effusion,participants will receive thoracic radiotherapy (irradiation sites include residual primary lung tumor, regional lymph node metastases, and pleural metastases). Radiation prescription: DT 4000cGy/10F, 4Gy/fraction, once daily, 5 days/week (BED=56Gy, EQD2=46.67Gy, α/β=10). Radiotherapy for bone metastases: 3000cGy/10F, 3Gy/fraction, once daily, 5 days/week. Furmonertinib will be suspended before radiotherapy, during radiotherapy, and for 3 days after completion of radiotherapy. After radiotherapy, furmonertinib maintenance will continue until disease progression or unacceptable toxicity. This study hypothesizes that this treatment modality can effectively control malignant pleural effusion, significantly improve PFS in participants(and potentially OS), and that treatment-related toxicities will be tolerable.Furthermore, by dynamically monitoring ctDNA in peripheral blood using NGS technology before the initial furmonertinib treatment, before and after the first course of thoracic radiotherapy, and after disease progression, the investigators aim to identify individuals suitable for this treatment model and uncover new resistance mechanisms to furmonertinib under the radiotherapy plus TKI combination, thereby guiding clinical practice.
Study:
NCT07482605
Study Brief:
Protocol Section:
NCT07482605