Actively Recruiting
Adjuvant Treatment Based on MRD for EGFR Mutant NSCLC
Led by Guangdong Association of Clinical Trials · Updated on 2022-09-14
180
Participants Needed
16
Research Sites
420 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A prospective, multicenter clinical study designed to explore the efficacy of postoperative adjuvant EGFR-TKIs therapy based on MRD status in patients with stage IB-IIIB EGFR-mutant non-squamous non-small cell lung cancer (non-squamous NSCLC). Primary endpoints include 3-year Disease-Free Survival rate (3y-DFS) and median disease-free survival (mDFS).
CONDITIONS
Official Title
Adjuvant Treatment Based on MRD for EGFR Mutant NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent.
- Male or female aged 18 to under 80 years.
- Able to follow the study protocol, attend follow-up, and take oral medications.
- Completely resected pathological stage IB-IIIB NSCLC with EGFR exon 19 deletions, L861Q, G719X, or exon 21 L858R mutations.
- Recovered from R0 resection including lobectomy, sleeve surgery, or pneumonectomy.
- ECOG performance status of 0 or 1.
- Life expectancy of at least 12 weeks.
- Adequate blood counts: ANC ≥1.8 x 10^9/L, Platelets ≥100 x 10^9/L, Hemoglobin ≥9 g/dL.
- Adequate liver function: Total bilirubin ≤1.5 x ULN; AST and ALT ≤2.5 x ULN without liver metastases or ≤5 x ULN with liver metastases.
- Adequate kidney function: Serum creatinine ≤1.25 x ULN or estimated creatinine clearance ≥60 ml/min.
- Female participants must not be pregnant or breastfeeding.
You will not qualify if you...
- Known severe allergy to icotinib, osimertinib, or their components.
- Unable to comply with study procedures.
- Serious systemic disorders that may prevent study completion.
- Serious heart conditions such as recent myocardial infarction (within 6 months), angina, or heart disease.
- Interstitial pneumonia.
- Previous treatment with HER-targeting agents (e.g., erlotinib, gefitinib, icotinib, cetuximab, trastuzumab).
- Prior chemotherapy or systemic anti-tumor therapy.
- Prior radiotherapy to the primary tumor or lymph nodes.
- History of another cancer within the past 5 years except certain cured cancers.
- Unstable systemic diseases including active infections, uncontrolled hypertension, unstable angina, congestive heart failure, serious arrhythmias, hepatic, renal, or metabolic diseases.
- Untreated eye inflammation or infection.
- Any other disease or condition that increases risk with study treatment.
- Active serious infection (fever 38.0°C or higher).
- Presence of certain genetic mutations including exon 20 T790M, EGFR 20 insertions, ALK fusion, BRAF V600E, MET amplification, or KRAS mutation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Not Yet Recruiting
2
Chongqing University Three Gorges Hospital
Chongqing, China
Not Yet Recruiting
3
The First People's Hospital of Foshan
Foshan, China
Not Yet Recruiting
4
Fujian Medical University Union Hospital
Fuzhou, China
Not Yet Recruiting
5
Affiliated Cancer Hospital of Guangzhou Medical University
Guangzhou, China
Not Yet Recruiting
6
Nanfang Hospital Southern Medical University
Guangzhou, China
Not Yet Recruiting
7
Guangdong Provincial People's Hospital
Guanzhou, China
Actively Recruiting
8
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
Not Yet Recruiting
9
The First Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei, China
Not Yet Recruiting
10
The Affiliated Hospital of Inner Mongolia Hospital
Hohhot, China
Not Yet Recruiting
11
The Affiliated Hospital of Qingdao University
Qingdao, China
Not Yet Recruiting
12
Zhongshan Hospital Fudan University
Shanghai, China
Not Yet Recruiting
13
Shenzhen People's Hospital
Shenzhen, China
Not Yet Recruiting
14
Tongji Hospital Tongji College of HUST
Wuhan, China
Not Yet Recruiting
15
The First Affiliated Hospital of Xiamen University
Xiamen, China
Not Yet Recruiting
16
Zhongshan City People's Hospital
Zhongshan, China
Not Yet Recruiting
Research Team
Y
Yi-Long Wu, MD
CONTACT
R
Ri-Qiang Liao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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