Participant flow

A Study in Non Small Cell Lung Cancer · Source last updated 2018-05-18

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

groups

1. description

   Cycles 1-2 (21-day cycle): Day 1: pemetrexed 500 milligrams per square meter (mg/m\^2) + cisplatin 75 mg/m\^2 Day 2: LY2603618 130 to 275 milligrams (mg) After 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Pemetrexed, cisplatin, and LY2603618 were administered intravenously (IV) over 10 minutes, 1 hour, and 1 hour, respectively.

   id

   FG000

   title

   Phase 1: Pemetrexed + Cisplatin + LY2603618

2. description

   Cycles 1-4 (21-day cycle): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented. Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.

   id

   FG001

   title

   Phase 2: Pemetrexed + Cisplatin + LY2603618

3. description

   Cycles 1-4 (21-day cycle): Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Day 1: pemetrexed 500 mg/m\^2 Pemetrexed was administered IV over 10 minutes and cisplatin was administered IV over 1 hour.

   id

   FG002

   title

   Phase 2: Pemetrexed + Cisplatin

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         2

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         0

      type

      Protocol Violation

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         2

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         2

      type

      Physician Decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         39

      3. group Id

         FG002

         num Subjects

         23

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         39

      3. group Id

         FG002

         num Subjects

         22

      type

      Received at Least 1 Dose of Study Drug

   3. achievements

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         26

      3. group Id

         FG002

         num Subjects

         17

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         13

      3. group Id

         FG002

         num Subjects

         6

      type

      NOT COMPLETED

   title

   Overall Study

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice