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NCT00446225 · OUTCOME

Objective Response

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
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
From the date of randomization to the date of last follow up, assessed up to 24 months

What was measured

The objective response rate is defined as the percentage of patients who attain complete response (CR) or partial response (PR); response will be evaluated following RECIST criteria version 1.0. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters recorded on study.

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

Complete Response (CR)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A: Erlotinib Group2.3Not reportedNot reportedNot reportedNot reported
B: Standard Chemotherapy Group0Not reportedNot reportedNot reportedNot reported
Partial Response (PR)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A: Erlotinib Group62.8Not reportedNot reportedNot reportedNot reported
B: Standard Chemotherapy Group16.1Not reportedNot reportedNot reportedNot reported
Stable Disease (SD)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A: Erlotinib Group18.6Not reportedNot reportedNot reportedNot reported
B: Standard Chemotherapy Group49.4Not reportedNot reportedNot reportedNot reported
Progressive Disease (PD)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A: Erlotinib Group7Not reportedNot reportedNot reportedNot reported
B: Standard Chemotherapy Group12.6Not reportedNot reportedNot reportedNot reported
Missing (No Response Assessment)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A: Erlotinib Group9.3Not reportedNot reportedNot reportedNot reported
B: Standard Chemotherapy Group21.8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2.3
      2. group Id
        OG001
        value
        0
    title
    Complete Response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        62.8
      2. group Id
        OG001
        value
        16.1
    title
    Partial Response (PR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        18.6
      2. group Id
        OG001
        value
        49.4
    title
    Stable Disease (SD)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        12.6
    title
    Progressive Disease (PD)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        9.3
      2. group Id
        OG001
        value
        21.8
    title
    Missing (No Response Assessment)
denoms
  1. counts
    1. group Id
      OG000
      value
      86
    2. group Id
      OG001
      value
      87
    units
    Participants
description
The objective response rate is defined as the percentage of patients who attain complete response (CR) or partial response (PR); response will be evaluated following RECIST criteria version 1.0. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters recorded on study.
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
NUMBER
reporting Status
POSTED
time Frame
From the date of randomization to the date of last follow up, assessed up to 24 months
title
Objective Response
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice