Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT02332512
Eligibility Criteria:
Inclusion Criteria:
1. Subjects \>/= 18 years and \</=70 years of age at the time of Informed Consent.
2. Advanced relapsed or refractory predominantly NSCLC with documented wild-type EGFR.
3. At least one measurable lesion according to RECIST 1.1.
4. Failure of second line of chemotherapy.
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
6. Patients must have recovered from any AEs of prior treatments before randamization.
7. Adequate bone marrow,liver and renal function as assessed by the following laboratory tests conducted within 1 week before randomization. HB ≥ 90g/L; ANC≥1.5×10E+9/L; PLT≥80×10E+9/L; ALT and AST \< 2.5×ULN; TBIL ≤1.25×ULN; Cr ≤1.25×ULN;CL\>45 ml/min.
8. Life expectancy of at least three months.
9. Written informed consent and the willingness and ability to comply with all aspects of the protocol.
Exclusion Criteria:
1. Presence of types of small-cell, squamous-cell, adeno-squamous-cell lung cancer.
2. Pregnant or breast-feeding women.
3. Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female≥ 470 ms).Severe or uncontrolled systemic disease such as clinically significant hypertension(systolic pressure \>/= 140 mm Hg and/or diastolic pressure \>/= 90 mm Hg), and Grade III-IV cardiac insufficiency, according to NYHA criteria or echocardiography check: LVEF\<50%.
4. Factors to affect oral administration(inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction).
5. Coagulation disfunction,hemorrhagic tendency or receiving anticoagulant therapy\>/= CTCAE 2 pneumorrhagia or \>/= CTCAE 3 hemorrhage in other organs within 4 weeks.
6. Bone fracture or wounds that was not cured.
7. Arterial thrombus or phlebothrombosis within 12 months and taking anticoagulant agents.
8. Mental diseases and psychotropic substances abuse.
9. Previous treatment with an trial agent within 4 weeks
10. Previous treatment with VEGFR,platelet derived growth factor receptor(PDGFR) TKIs.
11. Proteinuria ≥ (++) or 24 hours total urine protein \> 1.0 g.
12. Other coexisting malignant disease (except basal-cell carcinoma and carcinoma in situ of uterine cervix).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02332512
Study Brief:
Protocol Section:
NCT02332512