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 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT01871805
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed, locally advanced, not amenable to curative therapy, or metastatic NSCLC
* ALK-rearrangement confirmed by the Food and Drug Administration (FDA) approved test
* NSCLC that has failed crizotinib treatment
* Measurable disease as defined by RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\<=) 2
* Adequate hematologic, hepatic and renal function
Exclusion Criteria:
* Prior therapy with ALK inhibitor other than crizotinib
* Brain or leptomeningeal metastases that are symptomatic and/or requiring treatment
* History of serious cardiac dysfunction
* History of or current active infection with hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
* Clinically significant gastrointestinal abnormality that would affect absorption of the drug
* Pregnant or lactating women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01871805
Study Brief:
Protocol Section:
NCT01871805