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 @ 4:47 PM
Ignite Modification Date:
2025-12-24 @ 4:47 PM
NCT ID:
NCT02119650
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of nonsquamous NSCLC that is Stage IIIB Stage IV, or recurrent after prior definitive intervention (radiation, surgery, or chemoradiation therapy, with or without adjuvant or neoadjuvant chemotherapy).
* Radiographically measurable or evaluable disease.
* Life expectancy of at least 12 weeks.
* Tumor without activating driver mutations for which there is available therapy (eg, tumor without mutations in epidermal growth factor receptor or anaplastic lymphoma).
* An modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below:
* Criteria:
* C-reactive protein \>10 mg/L AND albumin ≥35 g/L; Score = 1
* C-reactive protein \>10 mg L AND albumin \<35 g/L; Score = 2
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* Adequate renal, hepatic, and bone marrow function demonstrated by protocol-specified laboratory parameters at the screening visit.
Exclusion Criteria:
* Squamous or mixed histology (eg, adenosquamous) NSCLC
* Previous systemic therapy for advanced or metastatic disease.
* Known active central nervous system (CNS) metastases.
* Current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy without sponsor approval.
* Current uncontrolled cardiac disease such as angina or myocardial infarction, congestive heart failure including New York Heart Association functional classification of 3, or arrhythmia requiring treatment.
* Uncontrolled concomitant medical conditions, including, but not limited to, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric diseases.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02119650
Study Brief:
Protocol Section:
NCT02119650