Furmonertinib Plus Radiotherapy for EGFR+ NSCLC With Pleural Effusion

Sponsor
Jiangmen Central Hospital
Study ID
NCT07482605
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 1, 2026
Status verified
Mar 2026
Primary completion
Oct 30, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
63 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: experimental
    Patients receive furmonertinib combined with upfront thoracic radiotherapy. Furmonertinib is paused during the radiotherapy period and resumed after completion until disease progression.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: From date of first dose to date of first documented disease progression or death from any cause, assessed up to 24 months. ]

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