NCT07482605

Furmonertinib Plus Radiotherapy for EGFR+ NSCLC With Pleural Effusion

A Prospective, Multicenter Study on the Safety and Efficacy of Furmonertinib Combined With Local Chest Radiotherapy in EGFR+ Non-small Cell Lung Adenocarcinoma Patients With Malignant Pleural Effusion

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: Jiangmen Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer (NSCLC)
• Malignant Pleural Effusions (Mpe)- Pleurodesis

Interventions

Type	Name	Description
DRUG	Furmonertinib	80mg orally once daily, administered continuously except during the radiotherapy window.
RADIATION	Thoracic Radiotherapy (TRT)	Radiotherapy targeting residual primary tumor, regional lymph nodes, and pleural metastases (40Gy/10Fx) and bone metastases (30Gy/10Fx).

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-10-30
• Completion: 2028-01-01
• First posted: 2026-03-19
• Last updated: 2026-03-20