Furmonertinib Plus Radiotherapy for EGFR+ NSCLC With Pleural Effusion

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

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

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