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 @ 2:42 PM
Ignite Modification Date:
2025-12-24 @ 2:42 PM
NCT ID:
NCT00567359
Eligibility Criteria:
Inclusion Criteria:
* Pathologically confirmed diagnosis of NSCLC of adenocarcinoma histology
* Stage IA-B, IIA-B, or IIIA by the American Joint Committee on Cancer 7th edition staging criteria
* Patients must have undergone surgical resection with curative intent within 6 months of enrollment
* Sufficient tumor tissue available for EGFR mutation analysis
* At least ONE of the following patient characteristics: previously detected deletion 19 or L858R EGFR mutation, female sex, history of never smoking, or Asian/Pacific Rim ethnicity (to be enrolled in the screening portion of trial).
* 18 years of age or older
* Tumor samples must have either exon 19 deletion mutations or the exon 21 L858R point mutation
* ECOG Performance status of 0,1, or 2
* Adequate organ function as outlined in protocol
Exclusion Criteria:
* Radiographic evidence of recurrent NSCLC prior to erlotinib treatment
* Confirmed T790M resistance mutation in the primary tumor sample
* Prior exposure to EGFR tyrosine kinase inhibitors
* Known hypersensitivity to erlotinib, gefitinib, or any closely related drug
* Pregnant or breastfeeding women
* Any evidence of clinically active interstitial lung disease
* Current use of enzyme-inducing anti-epileptic drugs, including carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital, and primidone
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
* Use of any non-FDA approved or investigational agent within 2 weeks of enrolling onto the trial, or failure to recover from the side effects of any of these agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00567359
Study Brief:
Protocol Section:
NCT00567359