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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07485166
Eligibility Criteria:
Study Period:
ENCORE database 1 (EDB1): Patient identification period: 01/01/2011-04/30/2024 with follow-up information through data cut-off date on 04/30/2024
ENCORE database 2 (EDB2): Follow-up information through February 2023 (there is no specific time period restrictions for patient eligibility)
ENCORE database 4 (EDB4): Patient identification period: 10/01/2018-09/30/2023 with follow-up information through data cut-off date on 09/30/2023.
Inclusion Criteria:
* Age ≥18 years at treatment initiation
* Line-of-therapy setting is "advanced" (EDB1), "metastatic" (EDB2), or evidence of metastatic disease at treatment initiation (EDB4)
* Subjects with NSCLC who present with advanced/metastatic (Stage IIIB/ Stage IV) disease and received treatment with nivolumab or docetaxel is 2L for advanced/metastatic diseases
* ECOG 0 or 1 in the 90 days before/on treatment initiation
Exclusion Criteria:
* Patients without documentation of disease progression between initiation of 1L platinum doublet-based chemotherapy and initiation of nivolumab or docetaxel
* Patients with documentation of docetaxel or nivolumab use before treatment initiation
* Patients with documentation of immunotherapy use before treatment initiation
* Patients with any prior non-lung malignancy diagnosis (except non-melanoma skin cancers and specified in situ cancers: bladder, gastric, colon, cervical/dysplasia, endometrial, melanoma, or breast)
* Patients with documented autoimmune diseases within 2 years before/on treatment initiation
* Patients with documented interstitial lung disease before/on treatment initiation
* Patients with documented CNS metastases before/on treatment initiation
* Patients with any other anti-cancer therapy during the treatment assessment window
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07485166
Study Brief:
Protocol Section:
NCT07485166