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NCT00446225 · OUTCOME

Progression Free-survival

Phase III Study (Tarceva®) vs Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer in Patients With Mutations in the TK Domain of EGFR · Source last updated 2025-03-05

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 the date of randomization to the date of last follow up, assessed up to 24 months

What was measured

The time from enrollment in the study to tumor progression or death from any cause (whichever occurs first)

Groups in this outcome

A: Erlotinib Group

Erlotinib (Tarceva)150 mg /day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib Erlotinib: 150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib

B: Standard Chemotherapy Group

4 cycles of Chemotherapy: Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel. 3 week cycles of standard intravenous chemotherapy * 75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or * 75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8 Patients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead: * 3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or * 3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8 Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.

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

Analysis denominator · Participants

GroupSource count
A: Erlotinib Group86
B: Standard Chemotherapy Group87

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
A: Erlotinib Group9.4Not reported7.912.3Not reported
B: Standard Chemotherapy Group5.2Not reported4.45.8Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.27
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.64
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.42
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.27
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.64
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.42
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.9
        upper Limit
        12.3
        value
        9.4
      2. group Id
        OG001
        lower Limit
        4.4
        upper Limit
        5.8
        value
        5.2
denoms
  1. counts
    1. group Id
      OG000
      value
      86
    2. group Id
      OG001
      value
      87
    units
    Participants
description
The time from enrollment in the study to tumor progression or death from any cause (whichever occurs first)
dispersion Type
95% Confidence Interval
groups
  1. description
    Erlotinib (Tarceva)150 mg /day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib Erlotinib: 150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
    id
    OG000
    title
    A: Erlotinib Group
  2. description
    4 cycles of Chemotherapy: Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel. 3 week cycles of standard intravenous chemotherapy * 75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or * 75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8 Patients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead: * 3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or * 3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8 Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.
    id
    OG001
    title
    B: Standard Chemotherapy Group
param Type
MEDIAN
reporting Status
POSTED
time Frame
From the date of randomization to the date of last follow up, assessed up to 24 months
title
Progression Free-survival
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice