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The Efficacy of Double-dose Furmonertinib in the Treatment of Patients With Slow Osimertinib-resistant NSCLC

ConditionsNon Small Cell Lung CancerEGFR Gene MutationNon Small Cell Lung Cancer Stage IIIANon-small Cell Lung Cancer Stage IV
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University

About this trial

This study is a single-center, prospective, single-arm study of the efficacy of double-dose Furmonertinib in the treatment of patients with slow Osimertinib-resistant non-small cell lung cancer, mainly in patients with advanced non-small cell lung cancer with EGFR-sensitive mutations in stage IIIB or IV, slow drug resistance after treatment with Osimertinib, and no therapeutic target was found by secondary biopsy after drug resistance.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old;

EGFRm NSCLC of local progression (IIIB stage) or metastasis (IV stage);

previously confirmed to have EGFR (Ex19del or L858R) mutation, or T790M, received Osimertinib treatment. According to Recist 1.1 imaging findings, the focus progressed slowly and there was no systemic explosive progress (definition of slow progress: disease control > 6 months, slightly increased tumor load and symptom score ≤ 1);

patients who intend to use Furmonertinib (double dose, 160mg) anticancer therapy;

Disqualifiers

Patients who have been treated with Furmonertinib;

Patients who intend to use anticancer therapy other than Furmonertinib recently;

Contraindications for the use of Furmonertinib;

Trial population

Mainly targeted at IIIB or IV stage EGFR sensitive mutation advanced non-small cell lung cancer patients with slow drug resistance after Osimertinib treatment, and no treatable target was found by secondary biopsy after drug resistance.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Furmonertinib

    Drug

    Furmonertinib 40 mg/tablet, 4 tablets, QD

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Furmonertinib1 intervention

Trial outcomes

Primary outcomes

1

ORR

Objective response rate (ORR) including rate of CR and PR on based of RECIST 1.1

Time frame
Observation time 1-2 months.

Secondary outcomes

1

OS

Overall survival (OS) defined as the median time from randomization to death from any cause.

Time frame
through study completion (36 months)
2

PFS

Progression-free survival (PFS) the time from first dose of the study drug until the date of disease progression or death by any cause.

Time frame
through study completion (36 months)
3

DCR

Disease control rate (DCR) including rate of CR, PR and SD on based of RECIST 1.1

Time frame
through study completion (36 months)
4

AE

AE refers to any adverse medical event that occurs in patients who have taken a drug or in clinical research subjects, which is not necessarily causal to the drug.

Time frame
through study completion (36 months)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Lead sponsor

Source ClinicalTrials.gov

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