Participant flow

A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer · Source last updated 2025-12-05

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

groups

1. description

   Participants received atezolizumab, 1800 milligrams (mg), co-mixed with rHuPH20, as SC injection on Cycle 1 Day 1 (1 cycle=21 days), followed by atezolizumab, 1200 mg, as an IV infusion, every 3 weeks (Q3W) on Day 1 of subsequent cycles (1 cycle=21 days) until disease progression (PD), loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.

   id

   FG000

   title

   Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg

2. description

   Participants received atezolizumab, 1200 mg, co-mixed with rHuPH20, as SC injection, Q2W, on Day 1 of the first 3 cycles (Cycle 1-3=14 days), followed by atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.

   id

   FG001

   title

   Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg

3. description

   Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection, Q3W, on Day 1 of first 3 cycles, followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 for subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.

   id

   FG002

   title

   Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg

4. description

   Participants received atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity.

   id

   FG003

   title

   Part 2: Atezolizumab IV 1200 mg

5. description

   Participants received atezolizumab, 1875 mg, co-formulated with rHuPH20, as SC injection, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity.

   id

   FG004

   title

   Part 2: Atezolizumab SC 1875 mg

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         19

      4. group Id

         FG003

         num Subjects

         97

      5. group Id

         FG004

         num Subjects

         205

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         2

      5. group Id

         FG004

         num Subjects

         3

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      type

      New Therapy

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         17

      5. group Id

         FG004

         num Subjects

         28

      type

      Study Ended by Sponsor

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         8

      5. group Id

         FG004

         num Subjects

         11

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         15

      3. group Id

         FG002

         num Subjects

         39

      4. group Id

         FG003

         num Subjects

         124

      5. group Id

         FG004

         num Subjects

         247

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         13

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         8

      3. group Id

         FG002

         num Subjects

         26

      4. group Id

         FG003

         num Subjects

         124

      5. group Id

         FG004

         num Subjects

         247

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Study consisted of 2 parts: Part 1 (Dose Finding) \& Part 2 (Dose Confirmation). Health care professionals (HCPs) who administered the study treatment to participants were not enrolled in the study. To evaluate the HCPs' reported experience with administration of atezolizumab SC \& atezolizumab IV, the HCPs were asked to complete two questionnaires: 'HCP SC Versus IV Perspective' \& 'HCP SC Perspective'. No data other than the HCP's responses to these Questionnaires were collected in this study.

recruitment Details

A total of 438 participants with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) who were cancer immunotherapy (CIT)-naïve and for whom prior platinum-based therapy failed took part in the study across 23 countries from 27 December 2018 to 22 November 2024. The study is considered "Completed" because all the pre-planned study activities and analyses have been performed.

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

Preserved source evidence · Not medical advice