Participant flow

LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer · Source last updated 2025-01-16

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

groups

1. description

   Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state

   id

   FG000

   title

   Ceritinib

2. description

   Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance)

   id

   FG001

   title

   Chemotherapy

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         24

      2. group Id

         FG001

         num Subjects

         23

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         12

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Non-compliance with study treatment

   5. reasons

      1. group Id

         FG000

         num Subjects

         17

      2. group Id

         FG001

         num Subjects

         16

      type

      Physician Decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         99

      2. group Id

         FG001

         num Subjects

         107

      type

      Progressive disease

   7. reasons

      1. group Id

         FG000

         num Subjects

         22

      2. group Id

         FG001

         num Subjects

         26

      type

      Subject/guardian decision

   8. reasons

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         1

      type

      Study terminated by Sponsor

   9. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Protocol deviation

   10. reasons

       1. group Id

          FG000

          num Subjects

          0

       2. group Id

          FG001

          num Subjects

          1

       type

       No longer requires treatment

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         189

      2. group Id

         FG001

         num Subjects

         187

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         189

      2. group Id

         FG001

         num Subjects

         175

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         189

      2. group Id

         FG001

         num Subjects

         187

      type

      NOT COMPLETED

   title

   Treatment Period

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         17

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         11

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         5

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         54

      type

      Progressive disease

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         5

      type

      Study terminated by sponsor

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         10

      type

      Subject/guardian decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         102

      comment

      Extension-treatment phase was for patients who crossed over from chemotherapy to ceritinib treatment.

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         100

      comment

      Patients who crossed over to the ceritinib arm and received at least one dose of ceritinib

      type

      Crossover Analysis Set

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         102

      type

      NOT COMPLETED

   title

   Extension-treatment Phase

pre Assignment Details

Participants had to satisfy all the inclusion criteria none of the exclusion criteria prior to randomization.

recruitment Details

Patients were enrolled in 134 centers across 27 countries.

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

Preserved source evidence · Not medical advice