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NCT03409614 · OUTCOME

Part 2: ORR Per IRC

Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer · Source last updated 2026-05-18

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
Up to 32 months

What was measured

ORR as assessed by IRC per RECIST 1.1 was defined as the percentage of participants with a BOR of confirmed CR or PR.

Analysis population: Part 2 participants only

Groups in this outcome

Part 2: Cemiplimab + Chemotherapy

Participants received cemiplimab plus platinum-based doublet chemotherapy

Part 2: Placebo + Chemotherapy

Placebo matching cemiplimab plus platinum-based doublet chemotherapy

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

Analysis denominator · Participants

GroupSource count
Part 2: Cemiplimab + Chemotherapy312
Part 2: Placebo + Chemotherapy154

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 2: Cemiplimab + Chemotherapy43.6Not reported38.049.3Not reported
Part 2: Placebo + Chemotherapy22.1Not reported15.829.5Not reported

Source statistical analyses

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

  1. ci Lower Limit
    1.802
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.415
    group Description
    All analyses based on final DBL were descriptive only with p-values reported as nominal.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Odds Ratio (OR)
    param Value
    2.820
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    1.802
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.415
    group Description
    All analyses based on final DBL were descriptive only with p-values reported as nominal.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Odds Ratio (OR)
    param Value
    2.820
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        38.0
        upper Limit
        49.3
        value
        43.6
      2. group Id
        OG001
        lower Limit
        15.8
        upper Limit
        29.5
        value
        22.1
denoms
  1. counts
    1. group Id
      OG000
      value
      312
    2. group Id
      OG001
      value
      154
    units
    Participants
description
ORR as assessed by IRC per RECIST 1.1 was defined as the percentage of participants with a BOR of confirmed CR or PR.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received cemiplimab plus platinum-based doublet chemotherapy
    id
    OG000
    title
    Part 2: Cemiplimab + Chemotherapy
  2. description
    Placebo matching cemiplimab plus platinum-based doublet chemotherapy
    id
    OG001
    title
    Part 2: Placebo + Chemotherapy
param Type
NUMBER
population Description
Part 2 participants only
reporting Status
POSTED
time Frame
Up to 32 months
title
Part 2: ORR Per IRC
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice