Participant flow

AZD9291 First Time In Patients Ascending Dose Study · Source last updated 2026-04-20

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

groups

1. description

   Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.

   id

   FG000

   title

   AZD9291 80mg Extension

2. description

   Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.

   id

   FG001

   title

   Dose Escalation

3. description

   Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.

   id

   FG002

   title

   Dose Expansion

4. description

   Cohort of patients receiving first-line treatment for EGFRm advanced NSCLC, in 80mg and 160mg AZD9291 capsule.

   id

   FG003

   title

   First Line

5. description

   US-only cohort of pre-treated EGFR patients receiving the tablet formulation of AZD9291 (80 mg).

   id

   FG004

   title

   80mg Tablet

6. description

   Japan-only cohort of patients (EGFR T790M mutation status determined from cytology samples) receiving AZD9291 80 mg tablet.

   id

   FG005

   title

   Japan Cytology

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         54

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         38

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         2

      6. group Id

         FG005

         num Subjects

         0

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         7

      4. group Id

         FG003

         num Subjects

         3

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         1

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         12

      3. group Id

         FG002

         num Subjects

         104

      4. group Id

         FG003

         num Subjects

         6

      5. group Id

         FG004

         num Subjects

         4

      6. group Id

         FG005

         num Subjects

         4

      type

      Objective Disease Progression

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         7

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         1

      type

      Other (not specified)

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         201

      2. group Id

         FG001

         num Subjects

         31

      3. group Id

         FG002

         num Subjects

         271

      4. group Id

         FG003

         num Subjects

         60

      5. group Id

         FG004

         num Subjects

         12

      6. group Id

         FG005

         num Subjects

         28

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         139

      2. group Id

         FG001

         num Subjects

         16

      3. group Id

         FG002

         num Subjects

         115

      4. group Id

         FG003

         num Subjects

         50

      5. group Id

         FG004

         num Subjects

         6

      6. group Id

         FG005

         num Subjects

         22

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         62

      2. group Id

         FG001

         num Subjects

         15

      3. group Id

         FG002

         num Subjects

         156

      4. group Id

         FG003

         num Subjects

         10

      5. group Id

         FG004

         num Subjects

         6

      6. group Id

         FG005

         num Subjects

         6

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

603 patients were enrolled and received treatment.

recruitment Details

Patients recruited to different cohorts. Dose escalation cohort of pre-treated patients in 5 dose groups. Dose expansion cohort (pre-treated) in same 5 dose groups. First line patient cohort. 80mg tablet cohort of pre-treated patients. Japan-only cohort (EGFR T790M+ by cytology). Phase II extension cohort in pre-treated EGFR T790M+ patients.

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

Preserved source evidence · Not medical advice