Participant flow

LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy · Source last updated 2019-02-15

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

groups

1. description

   Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.

   id

   FG000

   title

   Afatinib

2. description

   Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.

   id

   FG001

   title

   Erlotinib

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         5

      type

      Other than listed

   2. reasons

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         34

      type

      Worsening of underlying cancer disease

   3. reasons

      1. group Id

         FG000

         num Subjects

         68

      2. group Id

         FG001

         num Subjects

         52

      type

      Adverse Event

   4. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         3

      type

      Protocol Violation

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      type

      Lost to Follow-up

   6. reasons

      1. group Id

         FG000

         num Subjects

         28

      2. group Id

         FG001

         num Subjects

         20

      type

      Withdrawal by Subject

   7. reasons

      1. group Id

         FG000

         num Subjects

         265

      2. group Id

         FG001

         num Subjects

         279

      type

      Withdrew due to Progressive disease

   8. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         2

      type

      Randomised but bot treated

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         398

      2. group Id

         FG001

         num Subjects

         397

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         392

      2. group Id

         FG001

         num Subjects

         395

      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

         398

      2. group Id

         FG001

         num Subjects

         397

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Patients screened to ensure that they met all inclusion/exclusion criteria. Patients were not to be entered to trial treatment if any one of the specific entry criteria were not met. Tumor assessments at screening were completed within 21 days and other screening assessments were completed within 28 days, of randomization.

recruitment Details

Open-Label Phase-III trial to compare the efficacy of afatinib with erlotinib for the second-line treatment of patients with advanced non-small cell lung cancer, who completed at least 4 cycles of platinum-based doublet chemotherapy. Randomization ratio was 1:1. Stratification was based on race.

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Preserved source evidence · Not medical advice