Participant flow

A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants · Source last updated 2026-05-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.

   id

   FG000

   title

   Alectinib

2. description

   Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.

   id

   FG001

   title

   Crizotinib

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         22

      2. group Id

         FG001

         num Subjects

         32

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         2

      type

      Reason not specified

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Adverse Event

   4. reasons

      1. group Id

         FG000

         num Subjects

         76

      2. group Id

         FG001

         num Subjects

         73

      type

      Death

   5. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         8

      type

      Lost to Follow-up

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Physician Decision

   7. reasons

      1. group Id

         FG000

         num Subjects

         44

      2. group Id

         FG001

         num Subjects

         32

      type

      Study Terminated by Sponsor

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         152

      2. group Id

         FG001

         num Subjects

         151

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         152

      2. group Id

         FG001

         num Subjects

         151

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

A total of 303 participants were randomized and included in the intent-to-treat (ITT) population; 152 participants in the alectinib arm and 151 participants in the crizotinib arm.

recruitment Details

The study recruited treatment-naive participants with Anaplastic Lymphoma Kinase (ALK)-positive advanced Non-Small Cell Lung Cancer (NSCLC) in 29 countries from August 2014 to January 2016. The study achieved its protocol-defined definition of completion when the required number of death events was reached, at which point it could be terminated for all participants. The administrative study termination did not impact the overall study completion status.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice