ALTA-1L Study: A Phase 3 Study of Brigatinib Versus Crizotinib in ALK-positive Advanced Non-Small Cell Lung Cancer Patients

Official Title

A Phase 3 Multicentre Open-label Study of Brigatinib (AP26113) Versus Crizotinib in Patients With ALK-positive Advanced Lung Cancer

Summary:

A Phase 3 Multicentre Open-label Study of Brigatinib (AP26113) versus Crizotinib in ALK-positive Advanced Lung Cancer Patients

Trial Description

Primary Outcome:

  • Progression-free survival (PFS) as assessed by a blinded Independent Review Committee (bIRC)
Secondary Outcome:
  • Objective response rate (ORR)
  • Intracranial ORR
  • Intracranial PFS
  • Overall Survival (OS)
  • Health-related quality of life (HRQoL)
  • Percentage of patients with adverse events
  • Steady state pharmacokinetic (PK) parameter: Maximum Plasma Concentration [Cmax]
  • Steady state pharmacokinetic (PK) parameter: Minimum plasma concentration [Cmin]
  • Steady state pharmacokinetic (PK) parameter: Area Under the Curve [AUC]
  • Steady state pharmacokinetic (PK) parameter: Time to maximum plasma concentration (Tmax)
  • Steady state pharmacokinetic (PK) parameter: Apparent oral clearance [CL/F]
The purpose of this phase III, randomized, open-label, comparative, multicentre, international study is to compare the efficacy and safety of brigatinib to that of crizotinib in anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) patients who have not previously been treated with an ALK inhibitor. Participants will be randomized in a 1:1 ratio to receive either brigatinib, 90 milligrams (mg) orally once daily (QD) for 7 days, then a 180 mg orally QD, or crizotinib, 250 mg orally twice daily (BID). Participants will receive treatment until disease progression, intolerable toxicity, consent withdrawal, or death. The total estimated duration of the study is at least 5 years, including 2 years to accrue patients, with at least 3 years for treatment and follow-up.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society