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NCT02186847 · OUTCOME

Percentage of Participants With Distant Metastases

Chemotherapy and Radiation Therapy With or Without Metformin Hydrochloride in Treating Patients With Stage III Non-small Cell Lung Cancer · Source last updated 2026-07-13

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 last follow-up. Maximum follow-up at time of analysis was 47.2 months.

What was measured

Distant metastasis (DM) is defined as the appearance of ≥ 1 new lesions at any site (including pleural or pericardial effusion) outside of the following: the planned treatment volume, the same lobe(s) of the lung as the primary tumor, or regional lymph nodes. Time to DM is defined as time from randomization to the date of first DM, death without DM (competing risk), or last known follow-up (censored). DM rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. One-year rates are provided. Analysis occurred after 102 progression-free survival events were reported.

Analysis population: Eligible participants

Groups in this outcome

Chemoradiation

60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin

Metformin + Chemoradiation

Metformin plus 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin

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

Analysis denominator · Participants

GroupSource count
Chemoradiation81
Metformin + Chemoradiation86

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Chemoradiation17.2Not reported9.726.6Not reported
Metformin + Chemoradiation20.5Not reported12.430.2Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.71
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.34
    estimate Comment
    Reference level = Chemoradiation
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4075
    param Type
    Hazard Ratio (HR)
    param Value
    1.29
    statistical Comment
    Two-sided significance level = 0.05
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.71
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.34
    estimate Comment
    Reference level = Chemoradiation
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4075
    param Type
    Hazard Ratio (HR)
    param Value
    1.29
    statistical Comment
    Two-sided significance level = 0.05
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.7
        upper Limit
        26.6
        value
        17.2
      2. group Id
        OG001
        lower Limit
        12.4
        upper Limit
        30.2
        value
        20.5
denoms
  1. counts
    1. group Id
      OG000
      value
      81
    2. group Id
      OG001
      value
      86
    units
    Participants
description
Distant metastasis (DM) is defined as the appearance of ≥ 1 new lesions at any site (including pleural or pericardial effusion) outside of the following: the planned treatment volume, the same lobe(s) of the lung as the primary tumor, or regional lymph nodes. Time to DM is defined as time from randomization to the date of first DM, death without DM (competing risk), or last known follow-up (censored). DM rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. One-year rates are provided. Analysis occurred after 102 progression-free survival events were reported.
dispersion Type
95% Confidence Interval
groups
  1. description
    60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
    id
    OG000
    title
    Chemoradiation
  2. description
    Metformin plus 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
    id
    OG001
    title
    Metformin + Chemoradiation
param Type
NUMBER
population Description
Eligible participants
reporting Status
POSTED
time Frame
From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months.
title
Percentage of Participants With Distant Metastases
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice