ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (AL… (NCT02737501) | Clinical Trial Compass
CompletedPhase 3
ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants
United States275 participantsStarted 2016-05-26
Plain-language summary
The purpose of the study is to compare the efficacy of brigatinib to that of crizotinib in ALK+ locally advanced or metastatic non-small cell lung cancer (NSCLC) participants naive to ALK inhibitors, as evidenced by progression-free survival (PFS).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Have histologically or cytologically confirmed stage IIIB (and not a candidate for definitive multimodality therapy) or stage four (IV) NSCLC.
✓. Must have documented ALK rearrangement.
✓. Have sufficient tumor tissue available for central analysis.
✓. Have at least 1 measurable (that is, target) lesion per RECIST v1.1.
✓. Recovered from toxicities related to prior anticancer therapy to National Cancer Institute (of the United States) (NCI) Common Terminology Criteria for Adverse Events (version 4.0) (CTCAE v 4.0) grade be less than or equal to (\<=) 1.
✓. Are a male or female participants greater than or equal to (\>=)18 years old.
✓. Have adequate organ function, as defined by the study protocol.
✓. Have Eastern Cooperative Oncology Group (ECOG) performance status \<=2.
Exclusion criteria
✕. Previously received an investigational antineoplastic agent for NSCLC.
✕. Previously received any prior tyrosine kinase inhibitor (TKI), including ALK-targeted TKIs.
✕. Previously received more than 1 regimen of systemic anticancer therapy for locally advanced or metastatic disease.
✕. Received chemotherapy or radiation within 14 days of first dose of study drug, except stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT).
✕. Received anti-neoplastic monoclonal antibodies within 30 days of the first dose of study drug.
✕. Had major surgery within 30 days of the first dose of study drug, minor surgical procedures such as catheter placement or minimally invasive biopsies are allowed.
✕. Have been diagnosed with another primary malignancy other than NSCLC, except for adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or participants with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.
✕. Have symptomatic CNS metastases (parenchymal or leptomeningeal) at screening or asymptomatic disease requiring an increasing dose of corticosteroids to control symptoms within 7 days prior to randomization.