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 - N/A
Healthy Volunteers
Not accepted

Interventions

  • Furmonertinib — DRUG
    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.
  • Thoracic Radiotherapy (TRT) — RADIATION
    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.

Study Details

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 Dates

First listed
Mar 19, 2026
Start date
Jul 1, 2026
Status verified
Jul 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
    Subjects will receive an initial 10-12 weeks of furmonertinib therapy with or without therapeutic thoracentesis to achieve adequate control of malignant pleural effusion, followed by thoracic radiotherapy targeting residual primary pulmonary lesions, regional lymph node metastases, and pleural metastatic lesions, with or without radiotherapy to osseous, adrenal, hepatic, or brain metastases. Oral furmonertinib will be withheld before, during, and for 3 days after radiotherapy. Resumption of furmonertinib maintenance will occur 3 days after radiotherapy completion and continue until disease progression or unacceptable toxicity.

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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