Actively Recruiting
To Assess the Efficacy and Safety of Furmonertinib in Patients With Epidermal Growth Factor Receptor 20ins Mutation Positive Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy
Led by Juan LI, MD · Updated on 2024-01-05
20
Participants Needed
1
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase II, prospective, multi-centre study. To assess the efficacy and safety of furmonertinib in patients with epidermal growth factor receptor 20ins mutation positive stage IB-IIIA Non-small Cell Lung Carcinoma, following complete tumour resection with or without adjuvant chemotherapy. The study plans to enroll 20 subjects, treating with furmonertinib 160mg/d, until disease recurrence, death or intolerability. The maximum duration of treatment is three years. The primary endpoint is DFS. The secondary endpoint include DFS rate , OS and the change of HRQoL. In addition, the peripheral blood ctDNA will be collected and analyzed in this study
CONDITIONS
Official Title
To Assess the Efficacy and Safety of Furmonertinib in Patients With Epidermal Growth Factor Receptor 20ins Mutation Positive Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent before any study procedures
- Male or female aged 18 years or older
- Complete surgical removal of primary non-small cell lung cancer with negative margins
- Post-operative cancer stage IB, II, or IIIA based on pathology
- Fully recovered from surgery and any standard post-operative therapy
- Confirmed EGFR 20 insertion mutation diagnosed by Tier 3A hospitals
- ECOG performance status of 0 to 1
- Negative pregnancy test for premenopausal women with childbearing potential; females must not be breastfeeding
You will not qualify if you...
- Patients who only had segmentectomy or wedge resection
- Previous anticancer therapy except adjuvant platinum-based chemotherapy
- Current use of medications or supplements that strongly induce cytochrome P450 3A4
- Treatment with investigational drugs within five half-lives before study
- Other malignancies unless treated and disease-free for over 5 years
- Unresolved toxicities from prior treatments above grade 1 (except hair loss and certain neuropathies)
- Severe or uncontrolled systemic diseases including uncontrolled high blood pressure and active bleeding disorders
- Active infections such as hepatitis B, hepatitis C, or HIV
- Mean resting QTc interval over 470 msec on ECG
- Abnormal heart rhythms or conduction issues on ECG
- Risk factors for QTc prolongation or sudden unexplained death under 40 in first-degree relatives
- History of interstitial lung disease or related lung conditions requiring steroids
- Inadequate bone marrow or organ function
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sichuan cancer hospital
Chengdu, Sichuan, China, 610000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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