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Furmonertinib Plus Radiotherapy for EGFR+ NSCLC With Pleural Effusion

ConditionsLung Cancer (NSCLC)Malignant Pleural Effusions (Mpe)- Pleurodesis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangmen Central Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Furmonertinib

    Drug

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

  • Thoracic Radiotherapy (TRT)

    Radiation

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

Treatment groups

63 Participants
are divided into 1 treatment group
Group A: experimentalExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
From date of first dose to date of first documented disease progression or death from any cause, assessed up to 24 months.

Secondary outcomes

1

Overall Response Rate (ORR)

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

Time frame
At 3 months after completion of radiotherapy .
2

Malignant Pleural Effusion Control Rate .

Proportion of subjects with controlled malignant pleural effusion (complete response + partial response) according to MPE response criteria.

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

Disease Control Rate (DCR)

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

Time frame
At 3 and 6 months after completion of radiotherapy
4

Overall Survival (OS)

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

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangmen Central Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: