This is a randomized, open-label, multi-center, global, Phase III study to determine the
efficacy and safety of durvalumab + tremelimumab combination therapy + Standard of care
(SoC) chemotherapy or durvalumab monotherapy + SoC chemotherapy versus SoC chemotherapy
alone as first line treatment in patients with metastatic non small-cell lung cancer
(NSCLC) with tumors that lack activating epidermal growth factor receptor (EGFR)
mutations and anaplastic lymphoma kinase (ALK) fusions.
Additional locations may be listed on ClinicalTrials.gov for NCT03164616.
Locations matching your search criteria
United States
California
Los Angeles
UCLA / Jonsson Comprehensive Cancer CenterStatus: Active
Contact: Sandra Hernandez
Phone: 310-825-2621
Adult patients with a histologically or cytologically documented metastatic NSCLC, with
tumors that lack activating EGFR mutations and ALK fusions, are eligible for enrollment.
Patients will be randomized in a 1:1:1 ratio to receive treatment with durvalumab +
tremelimumab combination therapy + SoC chemotherapy, durvalumab monotherapy + SoC
chemotherapy, or SoC chemotherapy alone. Tumor evaluation scans will be performed until
objective disease progression as efficacy assessment. All patients will be followed for
survival until the end of the study. An independent data monitoring committee (IDMC)
composed of independent experts will be convened to confirm the safety and tolerability
of the proposed dose and schedule.
Lead OrganizationAstraZeneca Pharmaceuticals LP
