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 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 12:19 AM
NCT ID:
NCT00615758
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) and/or metastatic (stage IV) NSCLC
* No previous therapy for advanced/metastatic NSCLC is allowed
* age \>18 years
* bidimensionally measurable disease
* non-smokers (or ex-smokers with less than 5 pack-years smoking history)
* adenocarcinoma histology
* performance status (WHO) 0-3
* adequate liver (serum bilirubin \<1.5 times the upper normal limit (UNL); AST and ALT \<2.5 times the UNL in the absence of demonstrable liver metastases, or \<5 times the UNL in the presence of liver metastases); adequate renal function (serum creatinine \<1.5 times the UNL); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
* previous radiotherapy, either in the adjuvant setting or for the treatment of metastatic disease is allowed provided that the measurable lesions are outside the radiation fields
* patient able to take oral medication
* tissue sample for tumour mutational analysis is required
Exclusion Criteria:
* serious chronic skin conditions (e.g. psoriasis, eczema) that would preclude study participation
* active infection
* history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
* malnutrition (loss of ≥ 20% of the original body weight)
* performance status: 4
* psychiatric illness or social situation that would preclude study compliance
* pregnant or lactating women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00615758
Study Brief:
Protocol Section:
NCT00615758