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NCT04685135 · OUTCOME

Change From Baseline in Lung Cancer Symptom Scale (LCSS) 3-Item Global Index Score

Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation · Source last updated 2026-08-11

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

Measure
LEAST_SQUARES_MEAN
Unit
Score on a sclae
Interval / dispersion
95% Confidence Interval
Time frame
Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)

What was measured

The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire for average 3-item global index score assesses the following 3 items (Distress/severity of symptoms from lung cancer, impact on normal activities, quality of life) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The 3 item global index score is average of all the 3 items ranging from 0 to 100 where high score represent worst outcome. LS mean and CI are from a repeated measures model on the response variable change from baseline in 3-item global index score.

Analysis population: Intent-To-Treat Population includes all participants who are randomized into this study.

Groups in this outcome

Adagrasib

Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with Adagrasib tablet or capsule orally at a starting dose of 600 mg twice a day (BID).

Docetaxel

Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m\^2 over 1 hour or according to institutional practices.

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

Analysis denominator · Participants

GroupSource count
Adagrasib301
Docetaxel152

Reported measurements

Source class 1
Values in Score on a sclae · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Adagrasib-3.0Not reported-20.314.3Not reported
Docetaxel15.9Not reported-2.634.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -20.3
        upper Limit
        14.3
        value
        -3.0
      2. group Id
        OG001
        lower Limit
        -2.6
        upper Limit
        34.3
        value
        15.9
denoms
  1. counts
    1. group Id
      OG000
      value
      301
    2. group Id
      OG001
      value
      152
    units
    Participants
description
The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire for average 3-item global index score assesses the following 3 items (Distress/severity of symptoms from lung cancer, impact on normal activities, quality of life) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The 3 item global index score is average of all the 3 items ranging from 0 to 100 where high score represent worst outcome. LS mean and CI are from a repeated measures model on the response variable change from baseline in 3-item global index score.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with Adagrasib tablet or capsule orally at a starting dose of 600 mg twice a day (BID).
    id
    OG000
    title
    Adagrasib
  2. description
    Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m\^2 over 1 hour or according to institutional practices.
    id
    OG001
    title
    Docetaxel
param Type
LEAST_SQUARES_MEAN
population Description
Intent-To-Treat Population includes all participants who are randomized into this study.
reporting Status
POSTED
time Frame
Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)
title
Change From Baseline in Lung Cancer Symptom Scale (LCSS) 3-Item Global Index Score
type
SECONDARY
unit Of Measure
Score on a sclae

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

Preserved source evidence · Not medical advice