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 @ 7:44 PM
Ignite Modification Date:
2025-12-24 @ 7:44 PM
NCT ID:
NCT00694603
Eligibility Criteria:
Inclusion Criteria:
* Pathologically confirmed stage IIIB or IV recurrent or progressive NSCLC
* Patients must have progressed while receiving treatment with a tyrosine kinase inhibitor targeting the EGFR pathway
* Measurable disease, as defined by RECIST criteria
* Patients must have a suitable frozen or paraffin-embedded tissue sample available for EGFR mutational analysis. Prior EGFR mutational analyses are allowable
* Patients with asymptomatic brain metastasis are eligible; however, they must have completed radiotherapy/radiosurgery at least 3 weeks prior to enrollment and be clinically stable
* ECOG Performance Status 0-2
* 18 years of age or older
* Negative pregnancy test within 7 days of treatment or be categorized as not of child-bearing potential
* Bone marrow function, renal function, hepatic function as outlined in protocol
Exclusion Criteria:
* Women who are pregnant of breastfeeding
* Active concurrent malignancy
* Major thoracic or abdominal surgery within 30 days prior to the first infusion of cetuximab
* Significant history of uncontrolled cardiac disease
* Uncontrolled seizure disorder, or active neurological disease
* Prior severe infusion reactions to a monoclonal antibody
* Prior chemotherapy regimen within 21 days prior to study entry
* Any EGFR tyrosine kinase inhibitor within 14 days of study entry
* Radiation therapy within 14 days prior to the first infusion of cetuximab
* Acute hepatitis or known HIV
* Active or uncontrolled infection
* Any concurrent chemotherapy or any other investigational agent(s)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00694603
Study Brief:
Protocol Section:
NCT00694603