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NCT02546986 · OUTCOME

Kaplan Meier Estimate of Progression-Free Survival (PFS) Based on Food and Drug Administration (FDA) Methodology

Safety and Efficacy Study of CC-486 With MK-3475 to Treat Locally Advanced or Metastatic Non-small Cell Lung Cancer · Source last updated 2026-07-22

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
90% Confidence Interval
Time frame
From Day 1 of study drug treatment to the date of disease progression; up to the clinical cut-off date of 12 April 2017; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the PBZ + Placebo arm

What was measured

PFS was defined according to the FDA Methodology as the time in months from the date of randomization to the date of disease progression according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 (documented by computed tomography scan, not including symptomatic deterioration) or death for (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Those who did not have disease progression or had not died as of the data cutoff date were censored at the time of the last radiologic assessment where the participant was documented to be progression-free prior to the data cutoff date. Progressive disease includes at least a 20% increase in the sum of diameters of target lesions from nadir or appearance of a new lesion.

Analysis population: The Intent-to-Treat population includes all participants who were randomized, regardless of whether they received assigned treatment or not.

Groups in this outcome

CC-486 and Pembrolizumab (CC-486 + PBZ)

Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.

Placebo and Pembrolizumab (PBO + PBZ)

Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.

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

Analysis denominator · Participants

GroupSource count
CC-486 and Pembrolizumab (CC-486 + PBZ)51
Placebo and Pembrolizumab (PBO + PBZ)49

Reported measurements

Source class 1
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
CC-486 and Pembrolizumab (CC-486 + PBZ)2.9Not reported1.84.0Not reported
Placebo and Pembrolizumab (PBO + PBZ)4.0Not reported1.58.0Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.926
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    2.038
    estimate Comment
    Hazard ratio and associated 2-sided 90% CIs were estimated using a Cox proportional hazard model
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.1789
    param Type
    Hazard Ratio (HR)
    param Value
    1.374
    statistical Comment
    Stratified by squamous cell carcinoma versus non-squamous cell carcinoma
    statistical Method
    Stratified Log-Rank Test
Complete source fields
analyses
  1. ci Lower Limit
    0.926
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    2.038
    estimate Comment
    Hazard ratio and associated 2-sided 90% CIs were estimated using a Cox proportional hazard model
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.1789
    param Type
    Hazard Ratio (HR)
    param Value
    1.374
    statistical Comment
    Stratified by squamous cell carcinoma versus non-squamous cell carcinoma
    statistical Method
    Stratified Log-Rank Test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.8
        upper Limit
        4.0
        value
        2.9
      2. group Id
        OG001
        lower Limit
        1.5
        upper Limit
        8.0
        value
        4.0
denoms
  1. counts
    1. group Id
      OG000
      value
      51
    2. group Id
      OG001
      value
      49
    units
    Participants
description
PFS was defined according to the FDA Methodology as the time in months from the date of randomization to the date of disease progression according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 (documented by computed tomography scan, not including symptomatic deterioration) or death for (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Those who did not have disease progression or had not died as of the data cutoff date were censored at the time of the last radiologic assessment where the participant was documented to be progression-free prior to the data cutoff date. Progressive disease includes at least a 20% increase in the sum of diameters of target lesions from nadir or appearance of a new lesion.
dispersion Type
90% Confidence Interval
groups
  1. description
    Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
    id
    OG000
    title
    CC-486 and Pembrolizumab (CC-486 + PBZ)
  2. description
    Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
    id
    OG001
    title
    Placebo and Pembrolizumab (PBO + PBZ)
param Type
MEDIAN
population Description
The Intent-to-Treat population includes all participants who were randomized, regardless of whether they received assigned treatment or not.
reporting Status
POSTED
time Frame
From Day 1 of study drug treatment to the date of disease progression; up to the clinical cut-off date of 12 April 2017; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the PBZ + Placebo arm
title
Kaplan Meier Estimate of Progression-Free Survival (PFS) Based on Food and Drug Administration (FDA) Methodology
type
PRIMARY
unit Of Measure
months

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Preserved source evidence · Not medical advice