Furmonertinib Plus Radiotherapy for EGFR+ NSCLC With Pleural Effusion

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangmen Central Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

Complicated with interstitial pneumonia or infectious fever before treatment;

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;

Trial design

Treatments tested in this trial

  • Furmonertinib
  • Thoracic Radiotherapy (TRT)

Treatment groups

63 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators