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 @ 6:34 PM
Ignite Modification Date:
2025-12-24 @ 6:34 PM
NCT ID:
NCT01964157
Eligibility Criteria:
Inclusion Criteria:
* Subjects with histologically or cytologically confirmed, unresectable NSCLC that carries a ROS1 rearrangement, as per FISH assay (Abbott Molecular Inc.)
* ECOG performance status of 0 to 2
* Male or female; ≥ 20 years of age
* Subjects must have received at least 1 platinum doublet to treat their locally advanced or metastatic NSCLC
* Subjects whose disease has progressed within 6 months Subjects with measurable lesion (using RECIST 1.1 criteria)
* Subjects must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 2
* Subjects must have archival tissue sample available, collected either at the time of diagnosis of NSCLC or any time since
* Provision of written informed consent prior to any study specific procedures
Exclusion Criteria:
* Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy.
* Any major operation or irradiation within 4 weeks of baseline disease assessment
* Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug
* Subjects 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
* Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ or treated thyroid cancer.
* Subjects with an uncontrolled major cardiovascular disease (including AMI within 12 months, unstable angina within 6 months, over NYHA class III congestive heart failure, congenital long QT syndrome, 2° or more AV Block and uncontrolled hypertension)
* Pregnant or lactating female
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01964157
Study Brief:
Protocol Section:
NCT01964157