Participant flow

A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC · Source last updated 2025-11-25

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

groups

1. description

   Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.

   id

   FG000

   title

   Lorlatinib

2. description

   Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.

   id

   FG001

   title

   Crizotinib

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         12

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         4

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         12

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         3

      type

      Global Deterioration of Health Status

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Subject decided to continue study treatment as per clinical practice in another hospital.

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Subject didn't receive study treatment.

   7. reasons

      1. group Id

         FG000

         num Subjects

         103

      2. group Id

         FG001

         num Subjects

         31

      type

      Ongoing

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         149

      2. group Id

         FG001

         num Subjects

         147

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         26

      2. group Id

         FG001

         num Subjects

         83

      comment

      "Completed" refers to participants with confirmed RECIST version 1.1 defined disease progression assessed by the blinded independent central review or investigator.

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         123

      2. group Id

         FG001

         num Subjects

         64

      type

      NOT COMPLETED

   title

   Treatment Phase

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         23

      2. group Id

         FG001

         num Subjects

         28

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         18

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         122

      2. group Id

         FG001

         num Subjects

         99

      type

      Ongoing

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         149

      2. group Id

         FG001

         num Subjects

         147

      comment

      The long-term follow-up phase included the post-treatment follow-up and the survival follow-up. Participants who started the long-term follow-up phase consisted of participants in both the post-treatment follow-up and the survival follow-up.

      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

         149

      2. group Id

         FG001

         num Subjects

         147

      type

      NOT COMPLETED

   title

   Long-Term Follow-up Phase

pre Assignment Details

Previously untreated Stage IIIB/IV participants with ALK-positive non-small cell lung cancer were randomized in this study.

recruitment Details

This phase 3, randomized, open label study was conducted at 104 sites in 23 countries. A total of 296 participants were randomized, 149 to the lorlatinib arm and 147 to the crizotinib arm.

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Preserved source evidence · Not medical advice