Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07482605

PHASE2

Furmonertinib Plus Radiotherapy for EGFR+ NSCLC With Pleural Effusion

Sponsor: Jiangmen Central Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-07-01

Completion Date

2028-01-01

Last Updated

2026-07-07

Healthy Volunteers

Conditions

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

Interventions

DRUG

Furmonertinib

Subjects will receive furmonertinib 80 mg orally once daily. The drug will be suspended before radiotherapy initiation, maintained on hold during the entire radiotherapy course, and withheld for an additional 3 days after radiotherapy ends, after which it will be resumed.

RADIATION

Thoracic Radiotherapy (TRT)

The radiotherapy target volume encompasses residual primary pulmonary lesions, regional lymph node metastases, and pleural metastases, with the option to additionally irradiate osseous, adrenal, hepatic, or brain metastases (with a maximum of 6 total irradiated sites and no more than 3 involved organs). Consolidative cranial irradiation for brain metastases will be deferred in cases where the residual lesion diameter is \<1 cm following furmonertinib therapy and the patient remains free of clinically significant neurological symptoms.

Inclusion Criteria: 1. Age ≥ 18 years. 2. Histologically or cytologically confirmed advanced lung adenocarcinoma. 3. Unlimited number of metastatic lesions, but with involvement of no more than 3 organs. 4. Previously untreated, clinical stage IV disease per AJCC/UICC 9th edition. 5. 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. 6. 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). 7. No prior thoracic radiotherapy. 8. Positive for EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R). 9. No prior systemic anticancer therapy. 10. ECOG performance status 0-2, with a life expectancy of ≥ 12 weeks. 11. At least one measurable lesion per RECIST 1.1. 12. 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. 13. Essentially normal hepatic and renal function: 1. Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (CrCl) ≥ 50 mL/min; 2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN is acceptable in patients with liver metastases); 3. Total bilirubin (TBIL) ≤ 1.5 × ULN; 4. Albumin ≥ 30 g/L and prealbumin ≥ 150 g/L. 14. Asymptomatic brain metastases. 15. Written informed consent obtained from all subjects. Exclusion Criteria: 1. Pre-existing interstitial lung disease (ILD) or infectious fever prior to treatment. 2. Radiographic progression (PD) after 8-10 weeks of TKI therapy, or development of grade ≥ 2 ILD. 3. Concurrent autoimmune disease requiring long-term oral corticosteroid therapy. 4. Severe anemia. 5. Known hypersensitivity to furmonertinib. 6. Significant respiratory symptoms (e.g., chest tightness, cough) that preclude tolerance to radiotherapy. 7. 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. 8. Poorly controlled or continuously progressive pleural effusion after 8-10 weeks of furmonertinib therapy. 9. Symptomatic brain metastases.