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 @ 7:09 PM
Ignite Modification Date:
2025-12-24 @ 7:09 PM
NCT ID:
NCT02450903
Eligibility Criteria:
Key Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of Stage IIIb or IV NSCLC that carries an ALK rearrangement as determined locally by Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) test.
* Patients must have NSCLC that has progressed at study enrollment.
* Patients must have received previous treatment with alectinib for treatment of locally advanced or metastatic NSCLC. Prior therapy with crizotinib as ALK inhibitor therapy in addition to alectinib is allowed. Alectinib doesn't need to be the last therapy prior to study enrollment. No particular sequence of prior alectinib and crizotinib is required for enrollment.
* Patients must be chemotherapy-naïve or have received only one line of prior cytotoxic chemotherapy.
* Age 18 years or older at the time of informed consent.
Key Exclusion Criteria:
* Patients with known hypersensitivity to any of the excipients of LDK378.
* Prior therapy with other ALK inhibitor investigational agents except crizotinib and alectinib.
* Prior systemic anti-cancer (including investigational) therapy aside from alectinib, crizotinib and one regimen of previous cytotoxic chemotherapy for locally advanced or metastatic NSCLC.
* Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
* Patient with history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis.
* Patients with history of carcinomatous meningitis.
* Patient with a concurrent malignancy or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.
* Patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02450903
Study Brief:
Protocol Section:
NCT02450903