Trial Title:
Adjuvant Treatment Based on MRD for EGFR Mutant NSCLC
NCT ID:
NCT05536505
Condition:
MRD
Conditions: Keywords:
NSCLC
Adjuvant
EGFR mutation
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Genetic
Intervention name:
Adjuvant treatment for MRD positivity
Description:
The MRD positive group would receive icotinib as adjuvant treatment. When the peripheral
blood MRD turned negative, the subjects entered the drug withdrawal observation period.
When the MRD turned positive again, the subjects resumed icotinib treatment. If EGFR
T790M mutation was found, researchers would resume medication and choose osimertinib
therapy.
Arm group label:
MRD Positivity Post Operation
Summary:
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).
Detailed description:
All subjects enrolled in this clinical trial will receive peripheral blood MRD status
assessment within 1 week and 1 month after surgery, and will be divided into MRD positive
group (+) and MRD negative group (-) according to their results , followed by MRD status
assessment every 12 weeks.
The MRD positive group would receive icotinib as adjuvant treatment. When the peripheral
blood MRD turned negative, the subjects entered the drug withdrawal observation period.
When the MRD turned positive again, the subjects resumed icotinib treatment. If EGFR
T790M mutation was found, researchers would resume medication and choose osimertinib
therapy.
The MRD negative group (-) directly entered the follow-up observation period. When the
MRD status of peripheral blood turned positive, the subjects received osimertinib
treatment. When the MRD turned negative again, the subjects entered the drug withdrawal
observation period.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Written informed consent provided.
2. Males or females aged ≥18 years, < 80 years.
3. Able to comply with the required protocol and follow-up procedures, and able to
receive oral medications.
4. Target population is completely resected pathological stage IB-IIIB NSCLC with EGFR
exon 19 deletions, L861Q mutation, G719X mutation and exon 21 L858R activating
mutation.
5. Patients who have recovered from R0 resection including lobectomy, sleeve surgery
and pneumonectomy.
6. ECOG performance status 0-1.
7. Life expectancy ≥12 weeks.
8. Adequate hematological function: Absolute neutrophil count (ANC) ≥1.8 x 109/L, and
Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain
or exceed this level).
9. Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN),
Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in
subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.
10. Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min.
11. Female subjects should not be pregnant or breast-feeding.
Exclusion Criteria:
1. Known severe hypersensitivity to icotinib, osimertinib or any of the excipients of
this product.
2. Inability to comply with protocol or study procedures.
3. A serious concomitant systemic disorder that, in the opinion of the investigator,
would compromise the patient's ability to complete the study.
4. A serious cardiac condition, such as myocardial infarction within 6 months, angina,
or heart disease.
5. Interstitial pneumonia.
6. Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib,
gefitinib, icotinib, cetuximab, trastuzumab).
7. Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g.
monoclonal antibody therapy).
8. Patients with prior radiotherapy to primary lesion or lymph nodes.
9. History of another malignancy in the last 5 years with the exception of the
following: Other malignancies cured by surgery alone and having a continuous
disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the
skin and cured in situ carcinoma of the uterine cervix are permitted.
10. Any unstable systemic disease (including active infection, uncontrolled hypertension
(systolic pressure > 160mmHg, diastolic pressure > 100mmHg), unstable angina,
congestive heart failure, myocardial infarction within the previous year, serious
cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
11. Eye inflammation or eye infection not fully treated or conditions predisposing the
subject to this.
12. Evidence of any other disease, neurological or metabolic dysfunction, physical
examination or laboratory finding giving reasonable suspicion of a disease or
condition that contraindicated the use of an investigational drug or puts the
subject at high risk for treatment-related complications.
13. Patient who has active serious infection (e.g. pyrexia of or 38.0℃ over) Patients
who harboring exon 20 T790M mutation, EGFR 20 insertions, ALK fusion, BRAF V600E
mutation, MET amplification and KRAS mutation.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Friendship Hospital, Capital Medical University
Address:
City:
Beijing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yong Cui
Facility:
Name:
Chongqing University Three Gorges Hospital
Address:
City:
Chongqing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yi Liu, MD
Facility:
Name:
The First People's Hospital of Foshan
Address:
City:
Foshan
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Wei-Quan Gu, MD
Facility:
Name:
Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Affiliated Cancer Hospital of Guangzhou Medical University
Address:
City:
Guangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jian Zhao, MD
Facility:
Name:
Nanfang Hospital Southern Medical University
Address:
City:
Guangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Kai-Can M Cai, MD
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guanzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Ri-Qiang Liao, MD
Contact backup:
Last name:
Si-Yang M. Liu, MD
Facility:
Name:
The Second Affiliated Hospital Zhejiang University School of Medicine
Address:
City:
Hangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jun-Qiang Fan, MD
Facility:
Name:
The First Affiliated Hospital of USTC Anhui Provincial Hospital
Address:
City:
Hefei
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Li Ke
Facility:
Name:
The Affiliated Hospital of Inner Mongolia Hospital
Address:
City:
Hohhot
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhan-Lin Guo
Facility:
Name:
The Affiliated Hospital of Qingdao University
Address:
City:
Qingdao
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhuang Yu, MD
Facility:
Name:
Zhongshan Hospital Fudan University
Address:
City:
Shanghai
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Di Ge, MD
Facility:
Name:
Shenzhen People's Hospital
Address:
City:
Shenzhen
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Guang-Suo Wang
Facility:
Name:
Tongji Hospital Tongji College of HUST
Address:
City:
Wuhan
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiang-Ning Fu, MD
Facility:
Name:
The First Affiliated Hospital of Xiamen University
Address:
City:
Xiamen
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Guo-Jun Geng
Facility:
Name:
Zhongshan City People's Hospital
Address:
City:
Zhongshan
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yi Liang, MD
Start date:
September 13, 2022
Completion date:
October 1, 2030
Lead sponsor:
Agency:
Guangdong Association of Clinical Trials
Agency class:
Other
Source:
Guangdong Association of Clinical Trials
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05536505
