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 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT02426658
Eligibility Criteria:
Inclusion Criteria:
* Patients must have histologically confirmed Stage IV non-squamous histology non-small cell lung cancer
* ECOG performance status of 3
* Sensitizing epidermal growth factor receptor (EGFR), anaplastic lymphoma receptor tyrosine kinase (ALK) and ROS proto-oncogene 1, receptor tyrosine kinase (ROS-1) mutations are either negative or unknown
* Absolute neutrophil count \>= 1,500/mcL
* Platelets \>= 100,000/mcL
* Creatinine clearance \>= 45 mL/min
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
* Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document
* Ability to understand and complete the European Organization for Research and Treatment of Cancer (EORTC) quality of life (QOL) instruments
Exclusion Criteria:
* Patients who have previously received chemotherapy for non-small cell lung cancer, or have received radiotherapy within 2 weeks prior to entering the study, or who have not recovered from adverse events due to treatment more than 2 weeks earlier
* Patients whose tumors are positive for the sensitizing EGFR mutation
* Patients whose tumors are positive for the sensitizing ALK fusion
* Patients whose tumors are positive for the sensitizing ROS-1 fusion
* Patients may not be receiving any other investigational agents
* Patients with symptomatic or recurrent brain metastases should be excluded from this clinical trial
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to pemetrexed
* Pregnant women are excluded from this study; breastfeeding should be discontinued
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02426658
Study Brief:
Protocol Section:
NCT02426658