Status:
UNKNOWN
Gefitinib With Chemotherapy or Anti-angiogenesis in NSCLC Patients With Bim Deletion or Low EGFR Mutation Abundance
Lead Sponsor:
Qilu Pharmaceutical Co., Ltd.
Conditions:
Non-small-cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is an open-label, multicenter, randomized, phase II clinical trial, which aims to evaluate the effectiveness and safety of gefitinib versus combination of gefitinib and doublet chemotherapy or ap...
Detailed Description
BIM (bcl-2 interacting mediator of cell death) deletion polymorphism and low EGFR mutation abundance were poor clinical response markers to epidermal growth factor receptor tyrosine kinase inhibitors ...
Eligibility Criteria
Inclusion
- Volunteered for attending the study, and signed informed consent form (ICF)to participate in the study.
- Cytologically and Histologically documented, locally advanced or recurrent or metastatic (stage IIIb, IIIc, IV) non-small cell lung cancer patients .
- EGFR mutation (exon 19 deletion or exon 21 L858R) with Bim deletion or low abundance for EGFR mutation.
- Age range: 18 years to 75 years.
- Patients must have measurable lesion according to the RECIST (version 1.1) criteria.
- Life expectancy of ≥ 12 weeks
- ECOG (Eastern Cooperative Oncology Group) performance status of ≤ 1.
- Patients hadn't received past system treatment, including cytotoxic drugs; For patients who have received adjuvant or neoadjuvant chemotherapy appears recurrence or metastasis more than 6 months from accepting the last dose of chemotherapy drugs
- Adequate organ function as defined by the following criteria:
- Bone marrow function: absolute neutrophil count ≥ 1,500,000,000/L and platelet count ≥100,000,000,000/L and hemoglobin ≥9g/dL.
- Liver function: Total bilirubin ≤ 1.5 ULN (upper limit of normal). AP (alkaline phosphatase), AST ( aspartate aminotransferase) and ALT (alanine transaminase) ≤ 3 ULN in the absence of liver metastases or up to 5 ULN in case of liver metastases.
- Renal function: creatinine clearance ≥ 60 ml/min. (based on modified Cockcroft-Gault formula).
- INR （international normalized ratio）≤ 1.5, and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 ULN.
- For all females of childbearing potential a negative serum/urine pregnancy test must be obtained within 48 hours before enrollment. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential.
- Fertile men and women must use effective contraception.
Exclusion
- Histology confirmed for squamous carcinomas, including mixed gland scale cancer, small cell lung cancer.
- Poor controlled hypertension, it means systolic pressure ≥140 mmHg and/or diastolic pressure ≥90 mmHg after drug therapy.
- There are imaging evidence of tumor invading or closing to the pulmonary vessels (e.g., pulmonary artery, superior vena cava).
- Thrombosis in 6 months before enrollment, including pulmonary thrombosis or deep venous thrombosis., or patient had medical evidence or history of thrombosis or bleeding tendency regardless of the severity.
- Patients with medical history of hemoptysis (defined as about 2.5ml bright blood) 2 weeks before the enrollments.
- Proteinuria ≥++, or 24h proteinuria ≥1.0g.
- A uncontrolled clinical infection, activity, including but not limited to acute pneumonia.
- Patients with known liver disease: the hepatitis B virus (HBV) infection and hepatitis b virus DNA (HBV DNA) ≥ 500 copy number or ≥100 IU/ml; or more; or hepatitis C virus (HCV) infection; or liver cirrhosis, etc.
- Patients who are at risk of human immunodeficiency virus (HIV) or syphilis infection.
- Patients who have a difficulty in swallowing or drug absorption.
- There are diseases of alimentary canal such as active duodenal ulcer, the ulcerous colitis, intestinal obstruction or other conditions which can cause gastrointestinal bleeding or perforation in the investigator's opinion; or patient has a history of intestinal perforation, intestinal fistula.
- Evaluation of cardiac function: left ventricular ejection fraction \< 50% (echocardiography); Moderate or above disorders of mitral valve and tricuspid shut down;, serious/unstable angina or acute myocardial infarction coronary artery bypass surgery in 6 months before enrollment; patients with class 2 and above cardiac dysfunction according to New York heart association (NYHA) classification
- Stroke and transient ischemic in 12 months before enrollment.
- severe ulcer in the skin wound, trauma and mucosa or fractures have been not fully healed.
- Patients received CYP3A4 strong inhibitor and/or inducer in 2 weeks before enrollment; Patients received P-gp and breast cancer resistance protein (BCRP) substrates drug in 2 weeks before enrollment.
- Patients received other anti-tumor treatment at the same time.
- Patients exist serious psychological or mental abnormalities, so patient compliance is not sufficient.
- Poorly controlled serous cavity effusion, including but not limited to malignant pleural effusion, malignant pericardial effusion and malignant peritoneal effusion.
- Patients have a weight loss (≥10%) within 6 weeks before enrollment.
- The pregnancy of female patients test is positive or lactation women.
- Patients haven't been diagnosed other malignant disease, except the basal cell carcinoma and cervical carcinoma.
Key Trial Info
Start Date :
October 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03267654
Start Date
October 12 2017
End Date
December 30 2021
Last Update
August 3 2020
Active Locations (1)
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1
Shanghai Pulmonary Hospital;
Shanghai, Shanghai Municipality, China, 200000