Actively Recruiting
Furmonertinib Monotherapy and Combination Therapy in Advanced EGFR Mutant NSCLC With Uncleared ctDNA
Led by Sun Yat-sen University · Updated on 2022-08-31
280
Participants Needed
26
Research Sites
303 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
A
Allist Pharmaceuticals, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
EGFR mutation positive advanced NSCLC patients with uncleared ctDNA have poor prognosis, whether they can benefit from combination therapy has not been reported. This study aims to investigate the efficacy and safety of combination therapy compared with furmonertinib monotherapy in advanced EGFR mutant NSCLC with uncleared circulating tumor cell DNA.
CONDITIONS
Official Title
Furmonertinib Monotherapy and Combination Therapy in Advanced EGFR Mutant NSCLC With Uncleared ctDNA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent before any study procedures
- Be at least 18 years old
- Have an ECOG performance status of 0 to 1 with no significant worsening in the last 2 weeks and life expectancy of at least 12 weeks
- Have pathologically confirmed non-squamous non-small cell lung cancer
- Have advanced or metastatic non-small cell lung cancer that cannot be treated with surgery or radiotherapy
- Have EGFR 19Del or L858R mutation confirmed by histology or cytology and circulating tumor DNA test
- Have untreated advanced non-small cell lung cancer not suitable for curative surgery or radiotherapy
- Have at least one measurable tumor lesion according to RECIST 1.1
- For premenopausal women with childbearing potential, have a negative pregnancy test within 7 days before first dose and not be lactating
- Willing to use contraception during the study and for a period after stopping treatment
- Agree voluntarily to follow the study treatment and follow-up plan and accept oral medication
- Agree voluntarily to genetic research and provide sufficient fresh blood samples for testing
You will not qualify if you...
- Have squamous cell lung carcinoma
- Have a history of allergy to the study drug or similar drugs
- Have EGFR exon 20 insertion mutations confirmed at any time
- Have received prior treatments including EGFR tyrosine kinase inhibitors, intrapleural perfusion therapy within the last 28 days unless stable, major surgery within 4 weeks, radiotherapy affecting bone marrow within 4 weeks, certain strong CYP3A4 inhibitors or inducers within 7 days, traditional Chinese medicines with anti-tumor effects within 7 days, drugs that prolong QTc interval requiring continued use, or investigational drugs within 14 days or 5 half-lives
- Have received prior systemic anti-cancer therapy for advanced NSCLC within 6 months except certain neoadjuvant or adjuvant therapy
- Have unresolved toxic reactions from prior treatments exceeding grade 1 (except alopecia) or grade 2 for neuropathy
- Have spinal cord compression or symptomatic and unstable brain metastases unless treated, stable, and off steroids for at least 2 weeks
- Have other active or recent cancers within 5 years except controlled skin basal cell carcinoma, cervical carcinoma in situ, or breast ductal carcinoma in situ
- Have active digestive diseases or conditions causing gastrointestinal bleeding or inability to absorb oral medication
- Have severe or uncontrolled systemic diseases including uncontrolled hypertension, active bleeding, or infection
- Have a history of interstitial lung disease or related lung conditions requiring steroids
- Have known corneal injury
- Have inadequate bone marrow or organ function
- Have QT prolongation or significant heart rhythm abnormalities
- Are likely to have poor compliance with study requirements
- Are pregnant or breastfeeding
- Have had bone marrow transplant or blood transfusion within 120 days before genetic sample collection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
The First Hospital of Jilin University
Changchun, China
Not Yet Recruiting
2
Sichuan Provincial People's Hospital
Chengdu, China
Not Yet Recruiting
3
Dongguan People's Hospital
Dongguan, China
Not Yet Recruiting
4
Affiliated Dongyang Hospital of Wenzhou Medical University, Dongyang People's hospital
Dongyang, China
Not Yet Recruiting
5
The First People's Hospital of Foshan
Foshan, China
Not Yet Recruiting
6
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, China
Not Yet Recruiting
7
Nanfang Hospital, Southern Medical University
Guangzhou, China
Not Yet Recruiting
8
Sun Yat-sen University cancer center
Guangzhou, China
Actively Recruiting
9
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
Not Yet Recruiting
10
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
Not Yet Recruiting
11
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
Not Yet Recruiting
12
Zhejiang Provincial Hospital of Chinese Medicine
Hangzhou, China
Not Yet Recruiting
13
Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Sun Yat-sen University
Jiangmen, China
Not Yet Recruiting
14
Affiliated Jinhua Hospital, Zhejiang University School of Medicine
Jinhua, China
Not Yet Recruiting
15
Mianyang Central Hospital
Mianyang, China
Not Yet Recruiting
16
The First Affiliated Hospital of Nanchang University
Nanchang, China
Not Yet Recruiting
17
Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute
Shenyang, China
Not Yet Recruiting
18
Shijiazhuang People's hospital
Shijiazhuang, China
Not Yet Recruiting
19
The Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, China
Not Yet Recruiting
20
The Third Affiliated Hospital of Wenzhou Medical University, Rui'an People's Hospital
Wenzhou, China
Not Yet Recruiting
21
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Not Yet Recruiting
22
Yijishan Hospital, Wannan Medical College
Wuhu, China
Not Yet Recruiting
23
Tangdu Hospital, Fourth Military Medical University
Xi'an, China
Not Yet Recruiting
24
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Not Yet Recruiting
25
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
Not Yet Recruiting
26
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Not Yet Recruiting
Research Team
Z
Zhang MD Li, 58
CONTACT
F
Fang Wen Feng, 46
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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