Trial Title:
First-line Furmonertinib in Advanced NSCLC Patients With EGFR Uncommon Mutation
NCT ID:
NCT05548348
Condition:
Non-small Cell Lung Cancer
EGFR G719X
EGFR L861Q
EGFR S768I
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Aflutinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Furmonertinib 160 mg, Q.D.
Description:
Furmonertinib will be administered orally at a dose of 160 mg per time, Q.D.
Arm group label:
Furmonertinib treatment
Other name:
AST2818 160 mg, Q.D.
Summary:
Furmonertinib, a newly-designed pan-EGFR-TKI with a trifluoroethoxypyridine-based
molecule structure, has shown promising clinical efficacy in EGFR
Ex19del/L858R/T790M/Ex20ins mutant advanced NSCLC with an acceptable safety profile
without new signals from 80mg to 240mg dose level in phase 1-3 clinical trials. Whether
EGFR G719X/S768I/L861Q mutation positive advanced NSCLC patients can benefit from
first-line furmonertinib 160mg per day has not been reported. This study aims to
investigate the efficacy and safety of furmonertinib 160mg per day in EGFR
G719X/S768I/L861Q mutant patients under first-line treatment of advanced NSCLC setting.
Detailed description:
This is a single arm, multicenter study which will recruit about 30 patients in China.
The study is designed to evaluate the efficacy and safety of furmonertinib in the
first-line treatment of patients with EGFR G719X/S768I/L861Q mutations in advanced NSCLC.
Furmonertinib will be administered orally at a dose of 160 mg per time, Q.D.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Provide informed consent prior to any study specific procedures;
- 18 -70 years of age;
- ECOG PS of 0 to 1 at screening with no clinically significant deterioration in the
previous 2 weeks, life expectancy ≥12 weeks;
- Pathologically confirmed Non-Small Cell Lung Cancer (NSCLC);
- Locally advanced or metastatic NSCLC not amenable to curative surgery or
radiotherapy (stage IIIB-IV, according to the 8th edition of the AJCC staging
system);
- Patient with EGFR G719X or S768I or L861Q mutation diagnosed histologically or
cytologically, the reports must be issued or recognized by Tier 3A hospitals. The
mutations above may exist alone or together;
- No previous systemic anti-tumor therapy for locally advanced or metastatic NSCLC;
- According to RECIST 1.1, patients have at least one tumor lesion at baseline that
meets the following requirements: accurately and repeatably measurable at baseline
have no radiotherapy or biopsy;
- For premenopausal women with childbearing potential, a pregnancy test must be
performed within 14 days before the first dose, and the pregnancy test (blood or
urine test) must be negative; female subjects must not be lactating;
- Willing to use contraception (male patients); Voluntary and agree to follow the
study treatment protocol as well as follow-up plan, and can accept the oral medicine
treatment.
Exclusion Criteria:
- small cell lung carcinoma;
- History of hypersensitivity to active or inactive excipients of investigational
product (IP) or drugs with a similar chemical structure or class to investigational
product (IP);
- Confirmed EGFR Ex20ins or Ex19del or L858R or T790M mutant;
- Patient who receive prior treatment including: any Epidermal growth factor receptor
tyrosine kinase inhibitors (EGFR-TKI); the patients who have received intrapleural
perfusion therapy can only be enrolled 28 days or more after the pleural effusion is
stable; major surgery within 4 weeks of the first dose of investigational product
(IP); radiotherapy treatment to more than 30% of the bone marrow or with a wide
field of radiation within 4 weeks of the first dose of IP; CYP3A4 strong inhibitor
or strong inducer is used within 7 days prior to the first dose, or need to receive
these drugs during the study period; traditional Chinese medicine and traditional
Chinese medicine preparations with anti-tumor as indications and with adjuvant
treatment of tumor is used within 7 days prior to the first dose, or need to receive
these drugs during the study period; patients who are receiving drugs known to
prolong QTc interval or may cause torsade de pointe and need to continue to receive
these drugs during the study period; the time from the treatment with any other
investigational product or its analogue to the first dose does not exceed 5
half-lives of the drug or 14 days, whichever is longer.
- Prior treatment with any systemic anti-cancer therapy for advanced Non-Small Cell
Lung Cancer (NSCLC) including chemotherapy, biologic therapy, target therapy,
immunotherapy, or any investigational drug, except neoadjuvant or adjuvant therapy
before 6 months prior to the first dose IP;
- At the beginning of study treatment, any unresolved toxic reaction to prior
treatment is present, which exceeds Grade 1 in accordance with Common Terminology
Criteria for Adverse Events (CTCAE) (except for alopecia), and exceeds Grade 2 for
prior platinum treatment-related neuropathy;
- Spinal cord compression; symptomatic and unstable brain metastases, except for those
patients who have completed definitive therapy, are not on steroids, and have a
stable neurological status for at least 2 weeks after completion of the definitive
therapy and steroids.
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to
swallow the formulated product, or previous significant bowel resection that would
preclude adequate absorption of IP;
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled
hypertension, active bleeding diatheses, and active infection, which in the
Investigator's opinion makes it undesirable for the patient to participate in the
trial;
- Past medical history of Interstitial Lung Disease (ILD), drug-induced Interstitial
Lung Disease, radiation pneumonitis that required steroid treatment, or any evidence
of clinically active Interstitial Lung Disease;
- Any evidence of corneal injury;
- Inadequate bone marrow reserve or organ function;
- QT prolongation or any clinically important abnormalities in rhythm and heart
function;
- Pregnancy or lactation;
- Patients who may have poor compliance with the research procedures and requirements,
etc., as judged by investigators.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Second Affilicated Hospital of Chongqing Medical University
Address:
City:
Chongqing
Zip:
400010
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhenzhou Yang
Phone:
+8613883270881
Investigator:
Last name:
Zhenzhou Yang, M.D.
Email:
Principal Investigator
Facility:
Name:
Chongqing University Cancer Hospital
Address:
City:
Chongqing
Zip:
400030
Country:
China
Status:
Recruiting
Contact:
Last name:
Yongsheng Li
Phone:
+8617784310187
Email:
lys@cqu.edu.cn
Investigator:
Last name:
Yongsheng Li, M.D. & Ph.D.
Email:
Principal Investigator
Facility:
Name:
Army Specialty Medical Center
Address:
City:
Chongqing
Zip:
400042
Country:
China
Status:
Recruiting
Contact:
Last name:
Mengxia Li
Phone:
+8618580408265
Investigator:
Last name:
Mengxia Li, M.D.
Email:
Principal Investigator
Start date:
September 26, 2022
Completion date:
October 31, 2025
Lead sponsor:
Agency:
Chongqing University Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Army Specialty Medical Center
Agency class:
Other
Collaborator:
Agency:
The Second Affilicated Hospital of Chongqing Medical University
Agency class:
Other
Source:
Chongqing University Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05548348
