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NCT02998528 · OUTCOME

Time to Death or Distant Metastases (TTDM)

A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2026-01-06

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 randomization to the first date of distant metastasis or the date of death in the absence of distant metastasis (Up to approximately 84 months)

What was measured

TTDM is defined as the time between the date of randomization and the first date of distant metastasis or the date of death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that is outside of the thorax using blinded independent central review (BICR) according to response evaluation criteria in solid tumors (RECIST) 1.1. Patients who have not developed distant metastasis or died at the time of analysis will be censored on the date of their last evaluable tumor assessment.

Analysis population: All concurrently randomized participants in Arm C and Arm B

Groups in this outcome

Arm B: Platinum Doublet Chemo

Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.

Arm C: Nivo 360 mg + Platinum Doublet Chemo

Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.

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

Analysis denominator · Participants

GroupSource count
Arm B: Platinum Doublet Chemo179
Arm C: Nivo 360 mg + Platinum Doublet Chemo179

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm B: Platinum Doublet Chemo36.76Not reported24.7456.80Not reported
Arm C: Nivo 360 mg + Platinum Doublet Chemo64.66Not reported49.02NAInsufficient number of participants with events

Source statistical analyses

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

  1. ci Lower Limit
    0.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.90
    estimate Comment
    Stratified by: PD-L1 status (≥ 1% vs \<1%/not evaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.66
Complete source fields
analyses
  1. ci Lower Limit
    0.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.90
    estimate Comment
    Stratified by: PD-L1 status (≥ 1% vs \<1%/not evaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.66
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        24.74
        upper Limit
        56.80
        value
        36.76
      2. comment
        Insufficient number of participants with events
        group Id
        OG001
        lower Limit
        49.02
        upper Limit
        NA
        value
        64.66
denoms
  1. counts
    1. group Id
      OG000
      value
      179
    2. group Id
      OG001
      value
      179
    units
    Participants
description
TTDM is defined as the time between the date of randomization and the first date of distant metastasis or the date of death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that is outside of the thorax using blinded independent central review (BICR) according to response evaluation criteria in solid tumors (RECIST) 1.1. Patients who have not developed distant metastasis or died at the time of analysis will be censored on the date of their last evaluable tumor assessment.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
    id
    OG000
    title
    Arm B: Platinum Doublet Chemo
  2. description
    Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
    id
    OG001
    title
    Arm C: Nivo 360 mg + Platinum Doublet Chemo
param Type
MEDIAN
population Description
All concurrently randomized participants in Arm C and Arm B
reporting Status
POSTED
time Frame
From randomization to the first date of distant metastasis or the date of death in the absence of distant metastasis (Up to approximately 84 months)
title
Time to Death or Distant Metastases (TTDM)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice