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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+
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Furmonertinib

    Drug

    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.

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
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.

Time frame
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.

Time frame
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.

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: