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:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2025-12-24 @ 2:43 PM
NCT ID:
NCT03634059
Eligibility Criteria:
Inclusion Criteria:
1. Age:18 to 75 years old (man or female);
2. Pathologically diagnosed with non-squamous NSCLC;
3. Imageology diagnosed with locally advanced/metastatic or recurrent (stage ⅢB - IV);
4. Histologically or cytologic confirmed，harboring an activating EGFR mutation (19del or 21 L858R);
5. None previous chemotherapy or targeted therapy.（NOTE: neoadjuvant and adjuvant therapy is allowed）;
6. At least one measurable lesion (measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1)；
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
8. Major organ function has to meet the following criteria:
1. HB≥90g/L；
2. ANC≥1.5×109/L；
3. PLT≥80×109/L；
4. ALT and AST≤2.5ULN, but≤5ULN if the transferanse elevation is due to liver metastases;
5. TBIL≤1.5ULN;
6. Serum creatinine≤1.25ULN; Endogenous creatinine clearance rate\>45 ml/min;
9. Life expectancy greater than or equal to 3 months;
10. Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 7 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks;
11. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
Exclusion Criteria:
1. Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg);
2. Patients who suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association(NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)\<50%;
3. Radiologically documented evidence of major blood vessel invasion or encasement by cancer;
4. A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc);
5. Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (++). Has melena and hematemesis in two months;
6. Coagulant function abnormality (INR \> 1.5 ULN, APTT \> 1.5 ULN), with bleeding tendency;
7. Patients with pregnant or planning a pregnancy;
8. Patients with other malignant tumors within 5 years (except for the treated skin basal cell carcinoma and cervical carcinoma in situ);
9. History of psychiatric drugs abuse and can't quit or patients with mental disorders;
10. Less than 4 weeks from the last clinical trial;
11. The researchers think inappropriate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03634059
Study Brief:
Protocol Section:
NCT03634059