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NCT01828099 · OUTCOME

Overall Response Rate (ORR) by BIRC Assessment

LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer · Source last updated 2025-01-16

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 34 months

What was measured

ORR is defined as the percentage of patients with a best overall response defined as complete response (CR) or or partial response (PR) measured by BIRC per RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Analysis population: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.

Groups in this outcome

Ceritinib

Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state

Chemotherapy

Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance)

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

Analysis denominator · Participants

GroupSource count
Ceritinib189
Chemotherapy187

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ceritinib72.5Not reported65.578.7Not reported
Chemotherapy26.7Not reported20.533.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        65.5
        upper Limit
        78.7
        value
        72.5
      2. group Id
        OG001
        lower Limit
        20.5
        upper Limit
        33.7
        value
        26.7
denoms
  1. counts
    1. group Id
      OG000
      value
      189
    2. group Id
      OG001
      value
      187
    units
    Participants
description
ORR is defined as the percentage of patients with a best overall response defined as complete response (CR) or or partial response (PR) measured by BIRC per RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
dispersion Type
95% Confidence Interval
groups
  1. description
    Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state
    id
    OG000
    title
    Ceritinib
  2. description
    Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance)
    id
    OG001
    title
    Chemotherapy
param Type
NUMBER
population Description
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
reporting Status
POSTED
time Frame
Up to approximately 34 months
title
Overall Response Rate (ORR) by BIRC Assessment
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice