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Lung Cancer (NSCLC)Phase 2NCT07482605

Furmonertinib Plus Radiotherapy for EGFR+ NSCLC With Pleural Effusion

A Phase 2 study testing Furmonertinib and Thoracic Radiotherapy (TRT) in people with Lung Cancer (NSCLC) and Malignant Pleural Effusions (Mpe)- Pleurodesis, run by Jiangmen Central Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Furmonertinib and Thoracic Radiotherapy (TRT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
No sites listed yet
Study dates
1 Jul 2026to 1 Jan 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.
  • 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).
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  • No prior thoracic radiotherapy.
  • Positive for EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R).
  • No prior systemic anticancer therapy.
  • ECOG performance status 0-2, with a life expectancy of ≥ 12 weeks.
  • At least one measurable lesion per RECIST 1.1.
  • 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.
  • Essentially normal hepatic and renal function:
  • Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (CrCl) ≥ 50 mL/min;
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN is acceptable in patients with liver metastases);
  • Total bilirubin (TBIL) ≤ 1.5 × ULN;
  • Albumin ≥ 30 g/L and prealbumin ≥ 150 g/L.
  • Asymptomatic brain metastases.
  • Written informed consent obtained from all subjects.

Who cannot join

  • 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.
  • Known hypersensitivity to furmonertinib.
  • Significant respiratory symptoms (e.g., chest tightness, cough) that preclude tolerance to radiotherapy.
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  • 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.
  • Poorly controlled or continuously progressive pleural effusion after 8-10 weeks of furmonertinib therapy.
  • Symptomatic brain metastases.

About this study

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

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.

Read the detailed description

This study is designed as a prospective, multi-center investigation that plans to enroll 63 subjects with stage IV non-small cell lung adenocarcinoma harboring EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R mutation) complicated by malignant pleural effusions (MPE). Subjects will receive an initial 10-12 weeks of furmonertinib therapy with or without therapeutic thoracentesis to achieve adequate control of MPE, 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 (total irradiated sites ≤6, involved organs ≤3). For brain metastases, consolidative radiotherapy will be withheld if residual tumor diameter is <1 cm after furmonertinib treatment and no significant neurological symptoms are present.

  1. Radiotherapy techniques: Depending on the availability at each participating center, subjects may receive one of the following modalities:
  • Intensity-modulated radiation therapy (IMRT),
  • Volumetric-modulated arc therapy (VMAT),
  • Stereotactic body radiation therapy (SBRT),
  • Stereotactic radiosurgery (SRS), or
  • Fractionated stereotactic radiosurgery (fSRS).
  1. Prescription doses for primary and metastatic lesions: Based on institutional technical capabilities and the dose constraints of organs at risk in the radiotherapy plan, the following stereotactic or hypofractionated regimens are permissible:
  • Hypofractionated radiotherapy: DT 3000-4000 cGy/10 fractions, 3-4 Gy/fraction, once daily, 5 days/week;
  • SBRT: 27-50 Gy/3-5 fractions, 8-10 Gy/fraction, once daily, every other day;
  • SRS (for brain metastases): 20-24 Gy/fraction;
  • fSRS (for brain metastases): 27 Gy/3 fractions or 30 Gy/5 fractions.

Oral furmonertinib will be withheld before, during, and for 3 days after the completion of radiotherapy. Furmonertinib maintenance will be resumed 3 days after radiotherapy completion and continued until disease progression or unacceptable toxicity. We hypothesize that this treatment paradigm will effectively control MPE, significantly improve progression-free survival (and potentially overall survival), with manageable treatment-related toxicity.

Additionally, dynamic monitoring of peripheral blood ctDNA via next-generation sequencing (NGS) will be performed at two time points-before the first furmonertinib administration and one month after the completion of thoracic radiotherapy-to identify individuals most likely to benefit from this regimen and to elucidate resistance mechanisms to furmonertinib under the radiotherapy-plus-TKI combination, thereby informing clinical decision-making.

Being tested
Furmonertinib, Thoracic Radiotherapy (TRT)
Keywords
Furmonertinib, Radiotherapy, EGFR mutation, Lung adenocarcinoma
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Pleural Effusion, Malignant, Adenocarcinoma of Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FurmonertinibDrug

    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 groups in NCT07482605
Study groupRoleWhat they receive
experimentalExperimentalSubjects 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.
Receives: Drug: Furmonertinib; Radiation: Thoracic Radiotherapy (TRT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Overall Response Rate (ORR)

    Proportion of subjects achieving complete response (CR) or partial response (PR) according to RECIST v1.1.

    Measured: Evaluations are performed at 1 month post-radiotherapy, and subsequently every 3 months, with a total follow-up period of 18 months.

  2. Malignant pleural effusion recurrence rate

    Rate of MPE recurrence during the entire follow-up period following fumonertinib and local radiotherapy.

    Measured: Evaluations are performed at 1 month post-radiotherapy, and subsequently every 3 months, with a total follow-up period of 18 months.

  3. Disease Control Rate (DCR)

    Proportion of subjects achieving CR, PR, or stable disease (SD) according to RECIST v1.1.

    Measured: Evaluations are performed at 1 month post-radiotherapy, and subsequently every 3 months, with a total follow-up period of 18 months.

  4. Overall Survival (OS)

    Time from first dose of furmonertinib to death from any cause.

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

  5. Adverse event

    Frequency, severity, and relationship of adverse events assessed by CTCAE v5.0.

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

  6. Peripheral Blood ctDNA Level

    Dynamic changes in circulating tumor DNA (ctDNA) concentration in peripheral blood measured by next-generation sequencing (NGS).

    Measured: Next-generation sequencing (NGS) was used to detect circulating tumor DNA (ctDNA) in peripheral blood samples collected before the first furmonertinib treatment and 1 month after the completion of thoracic radiotherapy (2 time points in total).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion30 Oct 2027 (estimated)
  4. Study completion1 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Model Description
Masking
None (open label)
Enrolment
63 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07482605
Sponsor's protocol ID
2025 312 号 B
Status last verified
Jul 2026
First submitted
26 Feb 2026
Last updated
17 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37288833

  • 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.

    PubMed 39506792

  • 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.

    PubMed 36438852

  • 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.

    PubMed 35650550

  • 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.

    PubMed 38226415

  • 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.

    PubMed 37274290

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Furmonertinib and Thoracic Radiotherapy (TRT) in people with Lung Cancer (NSCLC) and Malignant Pleural Effusions (Mpe)- Pleurodesis, run by Jiangmen Central Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07482605, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.

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