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 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT01746251
Eligibility Criteria:
Inclusion Criteria:
* Pathologically confirmed diagnosis of non-small cell lung cancer with EGFR mutation
* Complete surgical resection, pathologic stage IA-B, IIA-B, IIIA-B by AJCC 7th Edition staging criteria
* Surgical resection with curative intent was at least 6 months prior to enrollment
* At least 3 weeks have passed since completion of adjuvant chemotherapy or radiotherapy
Exclusion Criteria:
* Pregnant or breastfeeding
* History of allergic reactions attributed to compounds of similar chemical composition to afatinib
* Prior exposure to EGFR tyrosine kinase inhibitor
* Evidence of clinically active interstitial lung disease
* Radiographic evidence of recurrent NSCLC prior to afatinib treatment
* Receipt of any experimental treatment within 30 days of start of treatment with afatinib until the end of treatment visit
* Use of potent P-gp inhibitors and potent P-gp inducers must be avoided during treatment with afatinib
* Individuals with a history of a different malignancy (except: synchronous or metachronous primary non-small cell lung cancers of lower stage than the cancer for which adjuvant treatment is currently being prescribed; disease free for at least 3 years; cervical cancer in situ; basal or squamous cell carcinoma of the skin)
* HIV positive on combination antiretroviral therapy
* Uncontrolled intercurrent illness
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01746251
Study Brief:
Protocol Section:
NCT01746251