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 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT02466568
Eligibility Criteria:
Inclusion Criteria:
* Histologic or cytologic diagnosis of advanced/metastatic adenocarcinoma of the lung
* Eastern Cooperative Oncology Group (ECOG) performance status of 0/1
* Chemotherapy naïve or have completed adjuvant chemotherapy for non-small cell lung cancer (NSCLC) \>6 months prior
* Adequate bone marrow, renal and hepatic function
* Must have measurable metastatic disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
* Mandatory archival tissue or willingness to undergo a fresh biopsy
* Life expectancy of greater than 6 months
Exclusion Criteria:
* Symptomatic brain metastasis or uncontrolled central nervous system (CNS) metastasis
* Pregnancy or breast feeding
* Serious uncontrolled medical disorder or active infection that would impair the participant's ability to receive study treatment
* Prior use of a PD1 or PDL1 inhibitor
* Concurrent use of other anticancer approved or investigational agents is not allowed
* Autoimmune disorders
* Prior malignancy in past 2 years
* Systemic steroids at doses greater than 10 mg/day of prednisone or the equivalent
* Any other pre-existing immunodeficiency condition (including known HIV infection)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02466568
Study Brief:
Protocol Section:
NCT02466568