Participant flow

A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer · Source last updated 2026-09-09

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

groups

1. description

   Participants received atezolizumab, 1200 milligrams (mg), every 3 weeks (Q3W) as intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide, in accordance with local standard of care, on Days 1, 2, and 3 of each cycle for up to 4 cycles.

   id

   FG000

   title

   Atezolizumab + Carboplatin + Etoposide

2. description

   Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or disease progression (PD) whichever occurred first.

   id

   FG001

   title

   Atezolizumab

3. description

   Participants received atezolizumab, 1200 mg, Q3W as IV infusion and lurbinectedin, 3.2 milligrams per square meter (mg/m\^2), Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.

   id

   FG002

   title

   Atezolizumab+ Lurbinectedin

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         37

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         21

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Progressive Disease

   4. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Symptomatic Deterioration

   6. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Physician Decision

   7. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Protocol Violation

   8. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Reason not Specified

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         660

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         653

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      comment

      Enrolled SAS included all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized.

      type

      Enrolled Safety Analysis Set (SAS)

   3. achievements

      1. group Id

         FG000

         num Subjects

         571

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         89

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Enrollment Phase

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         135

      3. group Id

         FG002

         num Subjects

         112

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         0

      type

      Progressive Disease

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         3

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         102

      3. group Id

         FG002

         num Subjects

         126

      type

      Ongoing in Study

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         241

      3. group Id

         FG002

         num Subjects

         242

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         240

      3. group Id

         FG002

         num Subjects

         242

      comment

      SAS included all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.

      type

      SAS

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         241

      3. group Id

         FG002

         num Subjects

         242

      type

      NOT COMPLETED

   title

   Randomized Phase

pre Assignment Details

The study consists of 2 phases, an enrollment phase (induction phase), where participants received standard of care treatment with carboplatin, etoposide and atezolizumab, and a randomized phase (maintenance phase), where participants were randomized in 1:1 ratio to receive either atezolizumab + lurbinectedin or atezolizumab. The study is ongoing.

recruitment Details

A total of 660 participants with ES SCLC took part in the study across 96 investigative sites in 13 countries.

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Preserved source evidence · Not medical advice