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:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT01391260
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed diagnosis of non-squamous NSCLC; Stage ⅢA-ⅢB(not suitable for surgery) or stage Ⅳ(only single-site single transfer );
* Untreated patients, or who completed ≤ 2 cycles of first-line chemotherapy (chemotherapy regimen: paclitaxel, docetaxel + cisplatin) within the previous month;
* Patients with tumor EGFR mutation positive (exon 19 deletion mutation or exon 21 L858R substitution mutation);
* Patients must be informed of the investigational nature of the study and must sign an informed consent form;
* Presence of at least one measurable/evaluable according to RECIST criteria.
* ECOG performance Status 0-2 ;
* Patients must have a life expectancy \> 12 weeks;
* Patients with laboratory values as follows:WBC\>4.0 x 109/L; ANC≥1.5 x 109/L; PLT≥100 x 109/L; HGB≥10 g/dL; CR≤1.5 x ULN; TBIL\<1.5 x ULN; AST and ALT≤1.5 x ULN; LDH≤1.5 x ULN; AKP≤5 x ULN;
* FEV 1≥1.0L and \>50% Corresponding normal values;
* Patient candidate to standard platinum-based chemotherapy;
* Patients must be nonpregnant and non-lactating.Patients of childbearing potential must implement an effective method of contraception during the study. All female Patients, except those who are postmenopausal or surgically sterilized, must have a negative pre-study serum or urine pregnancy test.
Exclusion Criteria:
* Any evidence of clinically active interstitial lung disease;
* Diagnosis of any other malignancy during the last 5 years, except for in situ carcinoma of cervix uterine and squamous cell carcinoma of the skin；
* Pregnancy or lactating；
* Serious concomitant infection;
* MI within preceding 6 months or symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia;
* As judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg, unstable or uncompensated respiratory, cardiac, hepatic, or renal disease);
* Patients who are not suitable to participate in the trial according to researchers.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01391260
Study Brief:
Protocol Section:
NCT01391260