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NCT01822496 · OUTCOME

Percentage of Patients With Complete or Partial Response

Erlotinib Hydrochloride or Crizotinib and Chemoradiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer · Source last updated 2019-08-05

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
95% Confidence Interval
Time frame
From randomization to study termination. Maximum follow-up was 39.0 months

What was measured

Per the RECIST guideline v1.1 complete response is defined as the disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. No statistical testing was done due to early study termination.

Analysis population: Eligible patients with disease assessment

Groups in this outcome

EGFR: Erlotinib

Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.

EGFR: No Erlotinib

Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.

ALK: Crizotinib

Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.

ALK: No Crizotinib

Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.

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

Analysis denominator · Participants

GroupSource count
EGFR: Erlotinib10
EGFR: No Erlotinib15
ALK: Crizotinib6
ALK: No Crizotinib4

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
EGFR: Erlotinib50.0Not reported19.081.0Not reported
EGFR: No Erlotinib26.7Not reported4.349.1Not reported
ALK: Crizotinib66.7Not reported29.0100.0Not reported
ALK: No Crizotinib75.0Not reported32.6100.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        19.0
        upper Limit
        81.0
        value
        50.0
      2. group Id
        OG001
        lower Limit
        4.3
        upper Limit
        49.1
        value
        26.7
      3. group Id
        OG002
        lower Limit
        29.0
        upper Limit
        100.0
        value
        66.7
      4. group Id
        OG003
        lower Limit
        32.6
        upper Limit
        100.0
        value
        75.0
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      15
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      4
    units
    Participants
description
Per the RECIST guideline v1.1 complete response is defined as the disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. No statistical testing was done due to early study termination.
dispersion Type
95% Confidence Interval
groups
  1. description
    Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
    id
    OG000
    title
    EGFR: Erlotinib
  2. description
    Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
    id
    OG001
    title
    EGFR: No Erlotinib
  3. description
    Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
    id
    OG002
    title
    ALK: Crizotinib
  4. description
    Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
    id
    OG003
    title
    ALK: No Crizotinib
param Type
NUMBER
population Description
Eligible patients with disease assessment
reporting Status
POSTED
time Frame
From randomization to study termination. Maximum follow-up was 39.0 months
title
Percentage of Patients With Complete or Partial Response
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice