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 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT00112294
Eligibility Criteria:
Inclusion Criteria:
* Must have advanced or metastatic non-small cell lung cancer that has not been previously treated with any chemotherapy.
* Tumor/disease lesions that can be measured bidimensionally.
* Must be able to carry-out work of light or sedentary nature (e.g. light house work, office work).
* Adequate recovery from recent surgery or radiation therapy.
* Must be at least 4 weeks from last major surgery or prior treatment with an investigational agent. At least 12 weeks from any radiation therapy to chest.
* Accessible for treatment, follow-up and required visits at a participating center(s).
Exclusion Criteria:
* Prior chemotherapy or adjuvant chemotherapy for the treatment of lung cancer.
* Prior treatment with cetuximab or other epidermal growth factor (EGFR)-targeted therapy.
* Prior severe infusion reaction to antibody therapy.
* Concurrent malignancy (previous malignancy without evidence of disease for 5 years will be allowed to enter trial).
* Concurrent chemotherapy or therapy with another investigational agent not indicated in the protocol.
* Serious uncontrolled medical disorders that would impair the ability to receive therapy.
* History of myocardial infarction within prior 3 months, uncontrolled angina, uncontrolled arrhythmia, or uncontrolled congestive heart failure.
* Symptomatic or uncontrolled metastases in the central nervous system. Subjects receiving a glucocorticoid for central nervous system (CNS) metastases are not eligible, but those receiving an anticonvulsant are eligible.
* Peripheral neuropathy \>= grade 2 (Common Toxicity Criteria Adverse Event \[CTCAE\] Version 3.0).
* Inadequate hematologic and/or liver and/or kidney function.
* Sexually active and fertile individuals or partners of these individuals who are unwilling or unable to use an acceptable method of birth control for entire trial and up to 4 weeks after the study.
* Women who are pregnant or breastfeeding.
* Women with a positive pregnancy test on enrollment prior to study drug administration.
* Altered mental status or psychiatric condition that prohibits understanding or rendering of consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00112294
Study Brief:
Protocol Section:
NCT00112294