Participant flow

BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC) · Source last updated 2018-12-14

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

groups

1. description

   Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.

   id

   FG000

   title

   Afatinib 40 Milligram (mg)

2. description

   Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.

   id

   FG001

   title

   Gemcitabine / Cisplatin Chemotherapy

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         201

      2. group Id

         FG001

         num Subjects

         20

      type

      Progressive disease

   2. reasons

      1. group Id

         FG000

         num Subjects

         24

      2. group Id

         FG001

         num Subjects

         45

      type

      Other Adverse events

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         3

      type

      Non-compliant with protocol

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         7

      type

      Refused cont. medication

   6. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         9

      type

      Not treated

   7. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         0

      type

      Other than listed

   milestones

   1. achievements

      1. comment

         Randomised

         group Id

         FG000

         num Subjects

         242

      2. comment

         Randomised

         group Id

         FG001

         num Subjects

         122

      type

      STARTED

   2. achievements

      1. comment

         Treated

         group Id

         FG000

         num Subjects

         239

      2. comment

         Treated

         group Id

         FG001

         num Subjects

         113

      type

      Treated

   3. achievements

      1. comment

         At the time of data cut-off for last-patient out (07 December 2017)

         group Id

         FG000

         num Subjects

         0

      2. comment

         Completed 6 courses of chemotherapy

         group Id

         FG001

         num Subjects

         38

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         242

      2. group Id

         FG001

         num Subjects

         84

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

All patients were screened for eligibility to participate in the trial. Patients attended a specialist sites which ensured that they met all strictly implemented inclusion/exclusion criteria. Patients were not to be entered to trial treatment if any one of the specific entry criteria was violated.

recruitment Details

Two-arm, randomised (2:1 ratio), open-label, active-controlled, parallel-group comparison of afatinib versus gemcitabine / cisplatin chemotherapy.

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

Preserved source evidence · Not medical advice