High-dose Furmonertinib in the Treatment in Patients With Advanced, Metastatic NSCLC With Progressed After First- or Second-line Treatment With Osimertinib
NCT ID: NCT06394674
Last Updated: 2024-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
84 participants
INTERVENTIONAL
2024-05-01
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A: Furmonertinib 160mg QD
Furmonertinib (AST2818) 160mg QD. All patients enrolled into this group will receive furmonertinib 160mg daily.
Furmonertinib
Drug: Furmonertinib
Group B: Furmonertinib 240mg QD
Furmonertinib (AST2818) 240mg QD. All patients enrolled into this group will receive furmonertinib 240mg daily.
Furmonertinib
Drug: Furmonertinib
Interventions
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Furmonertinib
Drug: Furmonertinib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Progression of imaging-confirmed extracranial lesions after first- or second-line treatment with Osimertinib
* Previous genetic testing for a definite EGFR-sensitive mutation and imaging-confirmed extracranial lesion progression after first-line treatment with Osimertinib; or previous genetic testing for a definite T790M mutation and imaging-confirmed extracranial lesion progression after second-line treatment with Osimertinib.
* Pre-existing clinical benefit after treatment with Osimertinib, including CR, PR, SD (duration \>6 months);
* Patients with at least 1 measurable lesion according to the criteria for evaluating the efficacy of solid tumors (RECIST 1.1)
* Normal functioning of major organs
* Pre-menopausal women of childbearing potential with a negative serum or urine pregnancy test within 7 days prior to the first dose of the drug
* Subjects volunteered and signed a written informed consent form.
Exclusion Criteria
* Patients with non-lung adenocarcinoma, including squamous lung cancer or mixed histological types
* Progression of imaging-confirmed extracranial lesions after prior Osimertinib treatment with accessible treatment options after genetic testing
* Patients with symptomatic brain metastases, meningeal metastases or spinal cord compression
* Any unrecovered CTCAE \> grade 1 toxicity reaction following prior Osimertinib treatment at the start of study drug therapy
* Other malignant tumors within 5 years or history of other malignant tumours; except effectively controlled basal cell carcinoma of the skin, carcinoma in situ of the uterine cervix, ductal carcinoma in situ of the breast, papillary carcinoma of the thyroid, superficial bladder tumors, etc.
* History of interstitial pneumonia with previous diagnosis
* Other circumstances that, in the judgement of the investigator, make them unsuitable for inclusion in the study
18 Years
75 Years
ALL
No
Sponsors
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The General Hospital of Eastern Theater Command
OTHER
Shanghai Chest Hospital
OTHER
Fujian Provincial Hospital
OTHER
Shanghai Changzheng Hospital
OTHER
The First Affiliated Hospital of Bengbu Medical University
OTHER
The First People's Hospital of Changzhou
OTHER
Second Affiliated Hospital of Wannan Medical College
OTHER
Changhai Hospital
OTHER
Responsible Party
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Locations
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Changhai Hospital
Shanghai, , China
Countries
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Facility Contacts
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Other Identifiers
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CHEC2023-155
Identifier Type: -
Identifier Source: org_study_id
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