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 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT02299505
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of stage IIIB (and is not a candidate for definitive multimodality therapy) or IV ALK-positive NSCLC.
* Patients may have received one prior treatment regimen with crizotinib (all other ALK inhibitors are excluded).
* Patients may have received prior chemotherapy, biologic therapy, or other investigational agents. ALK inhibitors other than crizotinib are excluded.
* Patient has a World Health Organization (WHO) performance status 0-2.
Exclusion Criteria:
* Prior treatment with an ALK inhibitor other than crizotinib.
* History of carcinomatous meningitis.
* Presence or history of a malignant disease other than an ALK-positive advanced tumor that has been diagnosed and/or required therapy within the past 3 years.
* Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months)
* Patient has history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention).
* Patient has other severe, acute, or chronic medical conditions
* Patient is currently receiving treatment with warfarin sodium (Coumadin®) or any other coumarin-derivative anticoagulants.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02299505
Study Brief:
Protocol Section:
NCT02299505