Status:
NOT_YET_RECRUITING
The Efficacy of Double-dose Furmonertinib in the Treatment of Patients With Slow Osimertinib-resistant NSCLC
Lead Sponsor:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Conditions:
Non Small Cell Lung Cancer
EGFR Gene Mutation
Eligibility:
All Genders
18+ years
Brief Summary
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, mainl...
Detailed Description
According to the latest data released by the National Cancer Center in 2022, the incidence and mortality of cancer in China are increasing year by year. There are 4.064 million new cancer patients in ...
Eligibility Criteria
Inclusion
- 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;
- At least one tumor lesion in the patient can meet the following requirements: it has not been irradiated in the past and can be accurately measured, the longest diameter of the baseline phase is ≥ 10mm (in the case of lymph nodes, short axis ≥ 15mm is required), and the measurement method can be chest CT or PET-CT, as long as repeated measurements can be completed accurately;
- No treatable target was found in the second biopsy after drug resistance;
- The survival time was more than 3 months;
Exclusion
- Patients who have been treated with Furmonertinib;
- Patients who intend to use anticancer therapy other than Furmonertinib recently;
- Contraindications for the use of Furmonertinib;
Key Trial Info
Start Date :
November 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06117644
Start Date
November 1 2023
End Date
October 1 2026
Last Update
November 7 2023
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