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 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT02584634
Eligibility Criteria:
* Inclusion Criteria
* Diagnosis of advanced or metastatic NSCLC. Group A must be ALK negative NSCLC and Group B must be ALK positive NSCLC
* Group A at least one prior regimen of therapy
* Group B any number of prior regimens.
* Mandatory tumor tissue available
* At least one measurable lesion
* ECOG Performance status 0 or 1
* Adequate bone marrow, renal, liver and pancreatic function
* Negative pregnancy test for females of childbearing potential
* Group B Phase 2: No prior systemic treatment for advanced or metastatic disease (adjuvant and/or neoadjuvant therapies are allowed if completed at least 6 months prior to study entry. No prior tyrosine kinase inhibitor therapy is allowed at any time prior to study entry)
Exclusion Criteria:
* No prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody.
* No Severe or Chronic medical conditions including gastrointestinal abnormalities or significant cardiac history
* No active infection requiring systemic therapy
* Prior organ transplantation including allogenic stem cell transplantation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02584634
Study Brief:
Protocol Section:
NCT02584634