Participant flow

A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung · Source last updated 2017-11-06

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

groups

1. description

   Crizotinib 250 mg (milligram) capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of (Response Evaluation Criteria in Solid Tumors) RECIST v1.1 defined PD, as determined by Independent Radiology Review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.

   id

   FG000

   title

   Crizotinib

2. description

   Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)\^2 intravenous (IV) infusion according to standard of care was administered over 10 minutes (min); either cisplatin 75 mg/m\^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an area under the concentration time curve (AUC) of 5 or 6 milligram\*minute per millilitre (mg\*min/mL), approximately 30 min after end of pemetrexed infusion.

   id

   FG001

   title

   Chemotherapy

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         71

      2. group Id

         FG001

         num Subjects

         81

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         5

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         13

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      type

      Other

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Randomized but not treated

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         172

      2. group Id

         FG001

         num Subjects

         171

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         171

      2. group Id

         FG001

         num Subjects

         169

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         81

      2. group Id

         FG001

         num Subjects

         69

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         91

      2. group Id

         FG001

         num Subjects

         102

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants with histologically or cytologically proven diagnosis of locally advanced, recurrent, or metastatic non squamous non small cell lung cancer and tumors with measurable disease were enrolled. Participants were to be positive for translocation or inversion events involving the ALK gene locus as determined by an ALK break apart FISH test.

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Preserved source evidence · Not medical advice