Furmonertinib Plus Radiotherapy for EGFR+ NSCLC With Pleural Effusion

NCT07482605 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025 312 号 B
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Keywords

Furmonertinib; Radiotherapy; EGFR mutation; Lung adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  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 Outcomes (6)

• Overall Response Rate (ORR)

  At 3 months after completion of radiotherapy .

• Malignant Pleural Effusion Control Rate .

  At 1, 3, and 6 months after completion of radiotherapy .

• Disease Control Rate (DCR)

  At 3 and 6 months after completion of radiotherapy

• Overall Survival (OS)

  From date of first dose to date of death from any cause, assessed up to 36 months .

• Incidence of Treatment-Emergent Adverse Events

  From date of first dose to 30 days after last dose .

Study Arms (1)

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; Radiation: Thoracic Radiotherapy (TRT)

Interventions

Furmonertinib DRUG

80mg orally once daily, administered continuously except during the radiotherapy window.

experimental

Thoracic Radiotherapy (TRT) RADIATION

Radiotherapy targeting residual primary tumor, regional lymph nodes, and pleural metastases (40Gy/10Fx) and bone metastases (30Gy/10Fx).

experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Complicated with interstitial pneumonia or infectious fever before treatment;
• Complicated with autoimmune diseases or long-term oral corticosteroid use;
• Prior history of thoracic radiotherapy or thoracic surgery;
• Complicated with severe anemia, grade 3 WBC or PLT suppression;
• Allergic to third-generation TKIs;
• Obvious respiratory symptoms, intolerant to radiotherapy;
• 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;
• Poor control or continuous progression of pleural effusion after two consecutive months of TKI treatment;
• Patients with brain metastases or liver metastases.

Sponsors & Collaborators

• Jiangmen Central Hospital: lead

Related Publications (6)

• Li Q, Hu C, Su S, Ma Z, Geng Y, Hu Y, Jin H, Li H, Lu B. Impact of thoracic tumor radiotherapy on survival in non-small-cell lung cancer with malignant pleural effusion treated with targeted therapy: Propensity score matching study. Cancer Med. 2023 Jul;12(14):14949-14959. doi: 10.1002/cam4.6130. Epub 2023 Jun 8.

  PMID: 37288833 BACKGROUND

• Li W, Wu P, Liang Z, Li L, Chen Y, Zhang W, Zhang H, Fang C. Efficacy and safety of tyrosine kinase inhibitors with thoracic radiotherapy for patients with oncogene-mutated non-small cell lung cancer: a meta-analysis. Radiat Oncol. 2024 Nov 6;19(1):154. doi: 10.1186/s13014-024-02538-y.

  PMID: 39506792 BACKGROUND

• Hibino M, Hiranuma O, Takemura Y, Katayama Y, Chihara Y, Harada T, Fujita K, Kita T, Tamiya N, Tsuda T, Shiotsu S, Tamura Y, Aoyama T, Nakamura Y, Terashima M, Morimoto Y, Nagata K, Yoshimura K, Uchino J, Takayama K. Osimertinib and Bevacizumab Cotreatment for Untreated EGFR-Mutated NSCLC With Malignant Pleural or Pericardial Effusion (SPIRAL II): A Single-Arm, Open-Label, Phase 2 Clinical Trial. JTO Clin Res Rep. 2022 Oct 15;3(12):100424. doi: 10.1016/j.jtocrr.2022.100424. eCollection 2022 Dec.

  PMID: 36438852 BACKGROUND

• Nokihara H, Ogino H, Mitsuhashi A, Kondo K, Ogawa E, Ozaki R, Yabuki Y, Yoneda H, Otsuka K, Nishioka Y. Efficacy of osimertinib in epidermal growth factor receptor-mutated non-small-cell lung cancer patients with pleural effusion. BMC Cancer. 2022 Jun 1;22(1):597. doi: 10.1186/s12885-022-09701-2.

  PMID: 35650550 BACKGROUND

• Kiritani A, Amino Y, Uchibori K, Akita T, Harutani Y, Ogusu S, Tsugitomi R, Manabe R, Ariyasu R, Kitazono S, Yanagitani N, Nishio M. Efficacy of osimertinib in patients with EGFR-mutation positive non-small cell lung cancer with malignant pleural effusion. Thorac Cancer. 2024 Feb;15(5):402-409. doi: 10.1111/1759-7714.15210. Epub 2024 Jan 16.

  PMID: 38226415 BACKGROUND

• Li Q, Hu C, Su S, Ma Z, Geng Y, Hu Y, Li H, Lu B. Failure pattern and radiotherapy exploration in malignant pleural effusion non-small cell lung cancer treated with targeted therapy. Front Oncol. 2023 May 19;13:974735. doi: 10.3389/fonc.2023.974735. eCollection 2023.

  PMID: 37274290 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Pleural Effusion, Malignant; Adenocarcinoma of Lung

Interventions

aflutinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pleural Neoplasms; Pleural Effusion; Pleural Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Masking Description
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Oncology Department

Model Details: Model Description

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 19, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03