Furmonertinib Plus Radiotherapy for EGFR+ NSCLC With Pleural Effusion

Starting soon · Phase 2

Conditions studied: Lung Cancer (NSCLC), Malignant Pleural Effusions (Mpe)- Pleurodesis

In brief

This study is designed as a prospective, multi-center investigation to explore the efficacy and safety of furmonertinib combined with upfront thoracic radiotherapy with or without metastatic lesion radiotherapy in subjects with EGFR-mutant NSCLC and malignant pleural effusion (MPE), aiming to provide additional evidence-based medical support for optimizing the management of NSCLC-MPE subjects. In addition, peripheral blood ctDNA next-generation sequencing (NGS) will be performed at two time points-before the first furmonertinib treatment and one month after the completion of thoracic radiotherapy-to identify subpopulations most likely to benefit from this therapeutic approach and to elucidate resistance mechanisms specific to the radiotherapy-plus-furmonertinib combination, ultimately facilitating more personalized care for these subjects.

Key facts

Study ID

NCT07482605

Run by

Jiangmen Central Hospital

People needed

63

Starts

2026-07-01

Expected to finish

2028-01-01

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years.
• Histologically or cytologically confirmed advanced lung adenocarcinoma.
• Unlimited number of metastatic lesions, but with involvement of no more than 3 organs.
• Previously untreated, clinical stage IV disease per AJCC/UICC 9th edition.
• Presence of pleural effusion as indicated by chest CT or ultrasound; cytological confirmation of malignant cells in the pleural effusion is preferred. If malignant cells are not detected in the pleural effusion, chest CT with contrast or whole-body PET/CT must demonstrate unequivocal pleural nodular metastases.
• After 8-10 weeks of furmonertinib therapy with or without therapeutic thoracentesis, the overall radiographic response is assessed as effective (CR + PR + SD), and malignant pleural effusion is adequately controlled (defined as no pleural effusion or only minimal pleural effusion on ultrasound or chest CT: maximum depth < 3 cm, estimated volume < 500 mL). Concurrent minimal pericardial effusion is permissible (defined as maximum diastolic width < 1 cm on echocardiography, estimated volume < 100 mL).
• No prior thoracic radiotherapy.
• Positive for EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R).
• No prior systemic anticancer therapy.
• ECOG performance status 0-2, with a life expectancy of ≥ 12 weeks.
• At least one measurable lesion per RECIST 1.1.
• Adequate bone marrow function to tolerate anticancer treatment: WBC ≥ 3 × 10⁹/L, Hb ≥ 80 g/L, PLT ≥ 75 × 10⁹/L, and absolute neutrophil count (NEUT) ≥ 1.5 × 10⁹/L.
• Essentially normal hepatic and renal function:
• Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (CrCl) ≥ 50 mL/min;
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN is acceptable in patients with liver metastases);
• Total bilirubin (TBIL) ≤ 1.5 × ULN;
• Albumin ≥ 30 g/L and prealbumin ≥ 150 g/L.
• Asymptomatic brain metastases.
• Written informed consent obtained from all subjects.

You may not qualify if…

• Pre-existing interstitial lung disease (ILD) or infectious fever prior to treatment.
• Radiographic progression (PD) after 8-10 weeks of TKI therapy, or development of grade ≥ 2 ILD.
• Concurrent autoimmune disease requiring long-term oral corticosteroid therapy.
• Severe anemia.
• Known hypersensitivity to furmonertinib.
• Significant respiratory symptoms (e.g., chest tightness, cough) that preclude tolerance to radiotherapy.
• Active hepatitis B or C virus infection with concomitant grade > 2 hepatic impairment. Patients may be considered eligible if liver function recovers to grade 1 after active hepatoprotective therapy and antiviral treatment.
• Poorly controlled or continuously progressive pleural effusion after 8-10 weeks of furmonertinib therapy.
• Symptomatic brain metastases.

Full record on ClinicalTrials.gov

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