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NCT05740566 · OUTCOME

Overall Survival (OS)

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.

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization up to minimum of death or primary completion DCO date 29 January 2025; median (min, max) time on the study was 8.6 (0.1, 18.5) months

What was measured

OS was defined as time from randomization until death from any cause. Median overall survival was estimated using Kaplan-Meier method. 95% confidence intervals (CIs) were calculated using the Brookmeyer and Crowley method.

Analysis population: The ITT analysis set included all randomized participants.

Groups in this outcome

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.

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Standard of Care (SOC)255
Tarlatamab 1 mg to 10 mg Q2W254

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Standard of Care (SOC)8.3Not reported7.010.2Not reported
Tarlatamab 1 mg to 10 mg Q2W13.6Not reported11.1NAUpper CI was not calculable due to insufficient event data occurring above the median.

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.468
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.768
    estimate Comment
    Hazard ratios and 95% CIs are estimated using a stratified Cox proportional hazards model; a hazard ratio \<1.0 indicates a better survival of tarlatamab arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    p Value Comment
    P-value is calculated using a stratified log-rank test.
    param Type
    Hazard Ratio (HR)
    param Value
    0.599
    statistical Method
    Stratified log-rank test
Complete source fields
analyses
  1. ci Lower Limit
    0.468
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.768
    estimate Comment
    Hazard ratios and 95% CIs are estimated using a stratified Cox proportional hazards model; a hazard ratio \<1.0 indicates a better survival of tarlatamab arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    p Value Comment
    P-value is calculated using a stratified log-rank test.
    param Type
    Hazard Ratio (HR)
    param Value
    0.599
    statistical Method
    Stratified log-rank test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.0
        upper Limit
        10.2
        value
        8.3
      2. comment
        Upper CI was not calculable due to insufficient event data occurring above the median.
        group Id
        OG001
        lower Limit
        11.1
        upper Limit
        NA
        value
        13.6
denoms
  1. counts
    1. group Id
      OG000
      value
      255
    2. group Id
      OG001
      value
      254
    units
    Participants
description
OS was defined as time from randomization until death from any cause. Median overall survival was estimated using Kaplan-Meier method. 95% confidence intervals (CIs) were calculated using the Brookmeyer and Crowley method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants were randomized to receive treatment according to the local SOC chemotherapy (lurbinectedin, topotecan, or amrubicin \[Japan only\]) in 21-day cycles.
    id
    OG000
    title
    Standard of Care (SOC)
  2. 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
    OG001
    title
    Tarlatamab 1 mg to 10 mg Q2W
param Type
MEDIAN
population Description
The ITT analysis set included all randomized participants.
reporting Status
POSTED
time Frame
From randomization up to minimum of death or primary completion DCO date 29 January 2025; median (min, max) time on the study was 8.6 (0.1, 18.5) months
title
Overall Survival (OS)
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice