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 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT01101334
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed stage IIIB or IV NSCLC.
* Recurrent disease (either no response to treatment or subsequent relapse after an objective response) that has progressed after first line therapy.
* Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 criteria.
* ≥ 18 years of age.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
* Adequate organ and bone marrow function.
* Resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0 grade ≤ 1.
* Agreement to use effective contraception while on treatment and for at least 3 months after end of treatment.
Exclusion Criteria:
* Treatment with anticancer therapy within 3 weeks before study treatment.
* Therapeutic or palliative radiation therapy within 2 weeks or major surgery within 4 weeks before study treatment (except for radiotherapy for brain metastases).
* Administration of other thiazolidinediones (TZDs) within 4 weeks before study treatment.
* Current need for concomitant use of other TZDs during the study.
* Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection at time of screening.
* History of any of the following conditions within 6 months before initiating study treatment: diabetes mellitus requiring treatment with insulin or TZD agents; myocardial infarction with significant impairment of cardiac function; severe/unstable angina pectoris; coronary/peripheral artery bypass graft; New York Heart Association (NYHA) class III or IV congestive heart failure; malabsorption syndrome, chronic diarrhea (lasting \> 4 weeks), inflammatory bowel disease, or partial bowel obstruction.
* Pericardial or pleural effusion (eg, requiring drainage) or pericardial involvement with the tumor. Participants with minimal pleural effusion may be eligible upon request by Investigator and approval by Sponsor.
* Pregnant or breast feeding.
* Prior treatment with epidermal growth factor receptor (EGFR) inhibitors.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01101334
Study Brief:
Protocol Section:
NCT01101334