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 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT03348904
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed stage IV or recurrent NSCLC of squamous or non-squamous histology that is not amenable to therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
* No prior treatment with systemic anti-cancer therapy for Stage IV disease.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to1.
* Measurable disease by computed tomography or magnetic resonance imaging per RECIST v1.1.
* Documentation of program death ligand-1 (PD-L1) status of 0 to 49% by IHC performed by the central laboratory prior to randomization.
* Other protocol inclusion criteria may apply
Exclusion Criteria:
* Known epidermal growth factor receptor (EGFR) mutations sensitive to available targeted inhibitor therapy.
* Known ALK or ROS1 rearrangements sensitive to available targeted inhibitor therapy.
* Untreated central nervous system (CNS) metastases.
* Unevaluable PD-L1 status or PD-L1 status of ≥ 50% by IHC performed by a central laboratory.
* Carcinomatous meningitis.
* Active, known or suspected autoimmune disease.
* Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, IDO1 targeted agent, or any other antibody or drug targeting T cell co-stimulation or checkpoint pathways.
* History of allergy or hypersensitivity to platinum-containing compounds or study drug components.
* Physical and laboratory test findings outside the protocol-defined range.
* Other protocol exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03348904
Study Brief:
Protocol Section:
NCT03348904