Clareo Health | A Study of First-line Maintenance Erlotinib Versus Erlotinib at Disease Progression in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Platinum-Based Chemotherapy
A Study of First-line Maintenance Erlotinib Versus Erlotinib at Disease Progression in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Platinum-Based Chemotherapy
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
