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 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 1:15 AM
NCT ID:
NCT02542293
Eligibility Criteria:
Inclusion Criteria:
For inclusion in the study, patients should fulfill the following criteria:
* Aged at least 18 years
* Documented evidence of Stage IV NSCLC
* No activating EGFR mutation or ALK rearrangement
* No prior chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC
* World Health Organization (WHO) Performance Status of 0 or 1
* No Prior exposure to Immune Mediated Therapy (IMT), including, but not limited to, other antiCTLA4, antiPD1, anti PDL1,or antiPDL2 antibodies, excluding therapeutic anticancer vaccines
Exclusion Criteria:
Patients should not enter the study if any of the following exclusion criteria are fulfilled:
* Mixed small cell lung cancer and NSCLC histology, sarcomatoid variant
* Brain metastases or spinal cord compression unless the patient is stable (asymptomatic; no evidence of new or emerging brain metastases) and off steroids for at least 14 days prior to start of study treatment.
* Active or prior documented autoimmune or inflammatory disorders (e.g., Crohn's disease, ulcerative colitis)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
130 Years
Study:
NCT02542293
Study Brief:
Protocol Section:
NCT02542293