Furmonertinib Plus Radiotherapy for EGFR+ NSCLC With Pleural Effusion (NCT07482605) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Furmonertinib Plus Radiotherapy for EGFR+ NSCLC With Pleural Effusion
63 participantsStarted 2026-03-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years but ≤ 75 years;
✓. Histologically or cytologically confirmed advanced lung adenocarcinoma;
✓. Chest CT or whole-body PET-CT indicates pleural invasion with pleural effusion, and pleural fluid cytology confirms the presence of cancer cells. After 2 months of treatment with furmonertinib ± thoracentesis drainage, malignant pleural effusion is controlled (no pleural effusion or only ≤ 100 ml of pleural effusion), and a small amount of pericardial effusion may be present;
✓. No prior history of thoracic radiotherapy or thoracic surgery;
✓. Positive for EGFR-sensitive mutations (19del/L858R);
✓. No prior systemic anti-tumor therapy;
✓. ECOG performance status 0-1, with a life expectancy of ≥ 12 weeks;
✓. At least one measurable lesion (according to RECIST 1.1);
Exclusion criteria
✕. Complicated with interstitial pneumonia or infectious fever before treatment;
What they're measuring
1
Progression-Free Survival (PFS)
Timeframe: From date of first dose to date of first documented disease progression or death from any cause, assessed up to 24 months.
✕. Complicated with autoimmune diseases or long-term oral corticosteroid use;
✕. Prior history of thoracic radiotherapy or thoracic surgery;
✕. Complicated with severe anemia, grade 3 WBC or PLT suppression;
✕. Allergic to third-generation TKIs;
✕. Obvious respiratory symptoms, intolerant to radiotherapy;
✕. Active hepatitis B or hepatitis C infection, or currently undergoing antiviral treatment; patients with a clear history of HBV infection whose HBV DNA is at an undetectable level after previous active treatment may be enrolled;
✕. Poor control or continuous progression of pleural effusion after two consecutive months of TKI treatment;