Furmonertinib Plus Radiotherapy for EGFR+ NSCLC With Pleural Effusion

March 18, 2026 updated by: Lin Xiao, Jiangmen Central Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study plans to prospectively and multi-centrally enroll 63 participants with stage IVA non-small cell lung adenocarcinoma harboring EGFR-sensitive mutations (exon 19 deletion, exon 21 L858R mutation) and malignant pleural effusions (MPE). After initial treatment with 2 months of furmonertinib ± thoracentesis and drainage, leading to good control of malignant pleural effusion,participants will receive thoracic radiotherapy (irradiation sites include residual primary lung tumor, regional lymph node metastases, and pleural metastases). Radiation prescription: DT 4000cGy/10F, 4Gy/fraction, once daily, 5 days/week (BED=56Gy, EQD2=46.67Gy, α/β=10). Radiotherapy for bone metastases: 3000cGy/10F, 3Gy/fraction, once daily, 5 days/week. Furmonertinib will be suspended before radiotherapy, during radiotherapy, and for 3 days after completion of radiotherapy. After radiotherapy, furmonertinib maintenance will continue until disease progression or unacceptable toxicity. This study hypothesizes that this treatment modality can effectively control malignant pleural effusion, significantly improve PFS in participants(and potentially OS), and that treatment-related toxicities will be tolerable.Furthermore, by dynamically monitoring ctDNA in peripheral blood using NGS technology before the initial furmonertinib treatment, before and after the first course of thoracic radiotherapy, and after disease progression, the investigators aim to identify individuals suitable for this treatment model and uncover new resistance mechanisms to furmonertinib under the radiotherapy plus TKI combination, thereby guiding clinical practice.

Study Type

Interventional

Enrollment (Estimated)

63

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years but ≤ 75 years;
  2. Histologically or cytologically confirmed advanced lung adenocarcinoma;
  3. 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;
  4. No prior history of thoracic radiotherapy or thoracic surgery;
  5. Positive for EGFR-sensitive mutations (19del/L858R);
  6. No prior systemic anti-tumor therapy;
  7. ECOG performance status 0-1, with a life expectancy of ≥ 12 weeks;
  8. At least one measurable lesion (according to RECIST 1.1);
  9. Signed informed consent obtained;
  10. No more than 3 bone metastases.

Exclusion Criteria:

  1. Complicated with interstitial pneumonia or infectious fever before treatment;
  2. Complicated with autoimmune diseases or long-term oral corticosteroid use;
  3. Prior history of thoracic radiotherapy or thoracic surgery;
  4. Complicated with severe anemia, grade 3 WBC or PLT suppression;
  5. Allergic to third-generation TKIs;
  6. Obvious respiratory symptoms, intolerant to radiotherapy;
  7. Active hepatitis B or hepatitis C infection, or currently undergoing antiviral treatment; patients with a clear history of HBV infection whose HBV DNA is at an undetectable level after previous active treatment may be enrolled;
  8. Poor control or continuous progression of pleural effusion after two consecutive months of TKI treatment;
  9. Patients with brain metastases or liver metastases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental
Patients receive furmonertinib combined with upfront thoracic radiotherapy. Furmonertinib is paused during the radiotherapy period and resumed after completion until disease progression.
Drug: Furmonertinib
80mg orally once daily, administered continuously except during the radiotherapy window.
Radiation: Thoracic Radiotherapy (TRT)
Radiotherapy targeting residual primary tumor, regional lymph nodes, and pleural metastases (40Gy/10Fx) and bone metastases (30Gy/10Fx).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
PFS defined as time from first dose of furmonertinib to disease progression per RECIST v1.1 or death from any cause, whichever occurs first.
From date of first dose to date of first documented disease progression or death from any cause, assessed up to 24 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: At 3 months after completion of radiotherapy .
Proportion of subjects achieving complete response (CR) or partial response (PR) according to RECIST v1.1.
At 3 months after completion of radiotherapy .
Malignant Pleural Effusion Control Rate .
Time Frame: At 1, 3, and 6 months after completion of radiotherapy .
Proportion of subjects with controlled malignant pleural effusion (complete response + partial response) according to MPE response criteria.
At 1, 3, and 6 months after completion of radiotherapy .
Disease Control Rate (DCR)
Time Frame: At 3 and 6 months after completion of radiotherapy
Proportion of subjects achieving CR, PR, or stable disease (SD) according to RECIST v1.1.
At 3 and 6 months after completion of radiotherapy
Overall Survival (OS)
Time Frame: From date of first dose to date of death from any cause, assessed up to 36 months .
Time from first dose of furmonertinib to death from any cause.
From date of first dose to date of death from any cause, assessed up to 36 months .
Incidence of Treatment-Emergent Adverse Events
Time Frame: From date of first dose to 30 days after last dose .
Frequency, severity, and relationship of adverse events assessed by CTCAE v5.0.
From date of first dose to 30 days after last dose .
Peripheral Blood ctDNA Level
Time Frame: 48 hours prior to the first furmonertinib treatment, 48 hours prior to the first thoracic radiotherapy, 48 hours after the completion of the last thoracic radiotherapy, and 48 hours after CT indicates disease progression.
Dynamic changes in circulating tumor DNA (ctDNA) concentration in peripheral blood measured by next-generation sequencing (NGS).
48 hours prior to the first furmonertinib treatment, 48 hours prior to the first thoracic radiotherapy, 48 hours after the completion of the last thoracic radiotherapy, and 48 hours after CT indicates disease progression.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangmen Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

October 30, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025 312 号 B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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