Actively Recruiting
A Study of Icotinib With Chemotherapy as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer
Led by Peking University Cancer Hospital & Institute · Updated on 2021-11-03
27
Participants Needed
1
Research Sites
266 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase II, single-Arm, prospective study of neoadjuvant Icotinib with chemotherapy for the treatment of patients with epidermal growth factor receptor mutation positive, resectable for stage II to IIIB(N2) Non-small Cell Lung Cancer
CONDITIONS
Official Title
A Study of Icotinib With Chemotherapy as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent to participate in the study.
- Male or female aged 18 to 75 years.
- Histologically or cytologically confirmed lung adenocarcinoma diagnosed within 60 days before enrollment.
- Clinical stage IIA, IIB, IIIA, or IIIB lung cancer assessed by specific imaging or biopsy and suitable for surgery.
- EGFR mutation detected by ARMS method, specifically Ex19del or L858R mutations.
- At least one measurable lesion on CT scan appropriate for repeat measurement.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate blood, liver, and kidney function for neoadjuvant therapy.
- Cardiopulmonary function suitable for surgery confirmed by ECG, echocardiography, pulmonary function, or blood gas analysis.
- Negative serum pregnancy test for women of childbearing potential.
- Women of non-childbearing potential must meet one of: postmenopausal for at least 12 months or confirmed by FSH level; documented hysterectomy and/or bilateral oophorectomy; or medically confirmed ovarian failure.
- Male participants must agree to use barrier contraception.
You will not qualify if you...
- Mixed squamous cell carcinoma, large cell carcinoma, or small cell lung cancer.
- Previous systemic anti-cancer treatment for NSCLC including chemotherapy, biologic therapy, immunotherapy, or investigational drugs.
- Pregnant or breastfeeding women.
- Current use of medications or herbal supplements that strongly induce CYP3A4 enzyme and cannot be stopped before treatment.
- Severe or uncontrolled systemic diseases such as uncontrolled hypertension or active bleeding.
- Active significant infections including hepatitis B, hepatitis C, HIV, or AIDS-related illnesses.
- Significant cardiovascular disease active or within 3 months before enrollment including stroke, heart attack, unstable angina, heart failure class II or higher, serious heart rhythm problems, or prolonged QT interval.
- History of allergy to Icotinib or similar drugs, severe nausea or vomiting, gastrointestinal diseases affecting drug absorption, or major bowel surgery affecting absorption.
- History or evidence of interstitial lung disease or radiation pneumonitis requiring steroid treatment.
- Inadequate bone marrow, kidney, or liver function as defined by specific blood count and chemistry thresholds.
AI-Screening
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Trial Site Locations
Total: 1 location
1
BeijingCancerH
Beijing, China, 100176
Actively Recruiting
Research Team
N
NAN Wu, M.D.
CONTACT
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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