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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT01328951
Eligibility Criteria:
Inclusion Criteria:
* Adults greater than or equal to (≥) 18 years of age, or legal age of consent if greater than 18
* Advanced or recurrent (Stage IIIB) or metastatic (Stage IV) NSCLC
* Completion of 4 cycles of platinum-based chemotherapy without progression (end of last chemotherapy cycle less than or equal to \[≤\] 28 days prior to randomization)
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion Criteria:
* Prior exposure to agents directed at human epidermal growth factor receptor (HER) axis (e.g. erlotinib, gefitinib, cetuximab)
* Participants whose tumors harbor an EGFR-activating mutation
* Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced disease before Screening
* Use of pemetrexed in maintenance setting (pemetrexed allowed during the chemotherapy run-in)
* Participants who have undergone complete tumor resection after responding to the platinum-based chemotherapy during the Screening phase
* Any other malignancies within 5 years, except for curatively resected carcinoma in situ of the cervix, basal or squamous cell skin cancer, ductal carcinoma in situ, or organ-confined prostate cancer
* Central nervous system (CNS) metastases or spinal cord compression that has not been definitely treated with surgery and/or radiation, or treated CNS metastases or spinal cord compression without stable disease for ≥2 months
* Human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection
* Any inflammatory changes of the surface of the eye
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01328951
Study Brief:
Protocol Section:
NCT01328951