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Clinical Trial Summary

This open-label, non-randomized, multicenter, Phase 1/2 study will evaluate the safety and efficacy of alectinib in participants with non-small cell lung cancer who have ALK mutation and failed crizotinib treatment. In Part 1, cohorts of participants will receive escalating doses of alectinib orally twice daily. In Part 2, participants will receive the recommended phase 2 dose (RP2D) of alectinib as determined in Part 1. Treatment will continue in Part 1 and Part 2 on the same dose until disease progression. In Part 3, following disease progression, participants without epidermal growth factor receptor (EGFR) mutation will be offered continued treatment with alectinib, participants with EGFR mutations will be offered a combination of alectinib and erlotinib.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT01801111
Study type Interventional
Source Hoffmann-La Roche
Contact
Status Completed
Phase Phase 1/Phase 2
Start date June 20, 2013
Completion date October 27, 2017

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