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NCT02546986 · OUTCOME

Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for a Minimum Duration of 18 Weeks Compared to Baseline

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
NUMBER
Unit
Percentage of Participants
Interval / dispersion
90% Confidence Interval
Time frame
Response was assessed every 6 weeks for the first 24 weeks, then every 9 weeks until DP, new anticancer initiation, or withdrawal of consent; maximum treatment exposure for CC-486 + PBZ was 61 weeks and 60 weeks for PBO +PBZ

What was measured

Disease control rate was defined as the percentage of participants who had confirmed stable disease, complete or partial response during the course of study, according to RECIST v1.1, as evaluated by the investigator. RECIST v 1.1 is defined as: - Complete response: disappearance of all target lesions - Partial response: at least a 30% decrease in the sum of diameters of target lesions from baseline - Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease - Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions from nadir or appearance of a new lesion. When stable disease was believed to be the best response, it must have met the minimum duration of 10 weeks from randomization.

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 Percentage of Participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
CC-486 and Pembrolizumab (CC-486 + PBZ)25.5Not reported15.837.4Not reported
Placebo and Pembrolizumab (PBO + PBZ)38.8Not reported27.151.5Not reported

Source statistical analyses

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

  1. ci Lower Limit
    -29.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    3.5
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.1572
    param Type
    Disease Control Rate Difference
    param Value
    -13.3
    statistical Comment
    Stratified by squamous cell carcinoma vs non-squamous cell carcinoma
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    -29.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    3.5
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.1572
    param Type
    Disease Control Rate Difference
    param Value
    -13.3
    statistical Comment
    Stratified by squamous cell carcinoma vs non-squamous cell carcinoma
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.8
        upper Limit
        37.4
        value
        25.5
      2. group Id
        OG001
        lower Limit
        27.1
        upper Limit
        51.5
        value
        38.8
denoms
  1. counts
    1. group Id
      OG000
      value
      51
    2. group Id
      OG001
      value
      49
    units
    Participants
description
Disease control rate was defined as the percentage of participants who had confirmed stable disease, complete or partial response during the course of study, according to RECIST v1.1, as evaluated by the investigator. RECIST v 1.1 is defined as: - Complete response: disappearance of all target lesions - Partial response: at least a 30% decrease in the sum of diameters of target lesions from baseline - Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease - Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions from nadir or appearance of a new lesion. When stable disease was believed to be the best response, it must have met the minimum duration of 10 weeks from randomization.
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
NUMBER
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
Response was assessed every 6 weeks for the first 24 weeks, then every 9 weeks until DP, new anticancer initiation, or withdrawal of consent; maximum treatment exposure for CC-486 + PBZ was 61 weeks and 60 weeks for PBO +PBZ
title
Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for a Minimum Duration of 18 Weeks Compared to Baseline
type
SECONDARY
unit Of Measure
Percentage of Participants

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Preserved source evidence · Not medical advice