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Trial Title:
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
Condition:
Non-Small Cell Lung Cancer
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Aflutinib
Conditions: Keywords:
furmonertinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Furmonertinib
Description:
Drug: Furmonertinib
Arm group label:
Group A: Furmonertinib 160mg QD
Arm group label:
Group B: Furmonertinib 240mg QD
Other name:
AST2818
Summary:
This is a prospective, randomised, uncontrolled phase II clinical trial planned to
include 84 subjects with metastatic lung adenocarcinoma that had progressed after first-
or second-line treatment with Osmertinib, who were randomly assigned to trial group 1 and
trial group 2, and were given Furmonertinib 160 mg and 240 mg once/day, orally,
respectively, with efficacy evaluated every 6 weeks until disease progression,
intolerable toxic side effects, or Subjects voluntarily withdrew informed consent.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically or cytologically confirmed metastatic lung adenocarcinoma
- 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:
- Previous chemotherapy or immunotherapy
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Changhai Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuchao Dong
Phone:
021-31166666
Email:
dongyc1020@aliyun.com
Start date:
May 1, 2024
Completion date:
September 2026
Lead sponsor:
Agency:
Changhai Hospital
Agency class:
Other
Collaborator:
Agency:
The General Hospital of Eastern Theater Command
Agency class:
Other
Collaborator:
Agency:
Shanghai Chest Hospital
Agency class:
Other
Collaborator:
Agency:
Fujian Provincial Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai Changzheng Hospital
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital Bengbu Medical College
Agency class:
Other
Collaborator:
Agency:
The First People's Hospital of Changzhou
Agency class:
Other
Collaborator:
Agency:
Second Affiliated Hospital of Wannan Medical College
Agency class:
Other
Source:
Changhai Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06394674
