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NCT05740566 · ADVERSE EVENTS

Adverse events

Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer · Source last updated 2026-01-05

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

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
All-cause mortality: from randomization up to primary completion DCO date 29 January 2025; median (min, max) time was 8.6 (0.1, 18.5) months. Adverse events were collected from first dose of drug up to last dose + 65 days up to primary completion DCO date 29 January 2025; median (min, max) time was 5.3 (0.1, 17.3) months.
Other-event reporting threshold
5%

All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Standard of Care (SOC)

Participants were randomized to receive treatment according to the local SOC chemotherapy (lurbinectedin, topotecan, or amrubicin \[Japan only\]) in 21-day cycles.

125 / 244234 / 244152 / 255
Tarlatamab 1 mg to 10 mg Q2W

Participants were randomized to receive tarlatamab as an IV infusion: A step dose of 1 mg on Cycle 1 Day 1 followed by the target dose 10 mg on Cycle 1 Day 8, Cycle 1 Day 15, and Q2W thereafter.

129 / 252244 / 252111 / 254

Group identifiers: EG000: Standard of Care (SOC) · EG001: Tarlatamab 1 mg to 10 mg Q2W

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      252
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      252
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      252
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      252
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      252
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      252
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      252
    term
    Angina pectoris
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      252
    term
    Angina unstable
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      252
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      252
    term
    Cardiac failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      252
    term
    Cardiac tamponade
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      252
    term
    Cardio-respiratory arrest

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      155
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      77
      num At Risk
      252
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      252
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      252
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      252
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      252
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      252
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      72
      num At Risk
      252
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      252
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      252
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      77
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      59
      num At Risk
      252
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      252
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      252
    term
    Asthenia
Complete source fields
description
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
event Groups
  1. deaths Num Affected
    152
    deaths Num At Risk
    255
    description
    Participants were randomized to receive treatment according to the local SOC chemotherapy (lurbinectedin, topotecan, or amrubicin \[Japan only\]) in 21-day cycles.
    id
    EG000
    other Num Affected
    234
    other Num At Risk
    244
    serious Num Affected
    125
    serious Num At Risk
    244
    title
    Standard of Care (SOC)
  2. deaths Num Affected
    111
    deaths Num At Risk
    254
    description
    Participants were randomized to receive tarlatamab as an IV infusion: A step dose of 1 mg on Cycle 1 Day 1 followed by the target dose 10 mg on Cycle 1 Day 8, Cycle 1 Day 15, and Q2W thereafter.
    id
    EG001
    other Num Affected
    244
    other Num At Risk
    252
    serious Num Affected
    129
    serious Num At Risk
    252
    title
    Tarlatamab 1 mg to 10 mg Q2W
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      155
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      77
      num At Risk
      252
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      252
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      252
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      252
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      252
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      252
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      72
      num At Risk
      252
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      252
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      252
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      77
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      59
      num At Risk
      252
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      252
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      252
    term
    Asthenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      252
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      252
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      252
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      252
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      252
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      252
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      252
    term
    Angina pectoris
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      252
    term
    Angina unstable
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      252
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      252
    term
    Cardiac failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      252
    term
    Cardiac tamponade
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      244
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      252
    term
    Cardio-respiratory arrest
time Frame
All-cause mortality: from randomization up to primary completion DCO date 29 January 2025; median (min, max) time was 8.6 (0.1, 18.5) months. Adverse events were collected from first dose of drug up to last dose + 65 days up to primary completion DCO date 29 January 2025; median (min, max) time was 5.3 (0.1, 17.3) months.

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