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NCT03409614 · OUTCOME

Part 1: Objective Response Rate (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 best overall response (BOR) of confirmed complete response (CR) or partial response (PR).

Analysis population: Part 1 participants only

Groups in this outcome

Part 1: Cemiplimab + Chemotherapy

Participants received cemiplimab plus platinum-based doublet chemotherapy

Part 1: Cemiplimab+AbbrevChemo+Ipilimumab

Participants received cemiplimab plus platinum-based doublet chemotherapy and ipilimumab

Part 1: Chemotherapy

Participants received 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 1: Cemiplimab + Chemotherapy108
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab109
Part 1: Chemotherapy106

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy40.7Not reported31.450.6Not reported
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab36.7Not reported27.746.5Not reported
Part 1: Chemotherapy28.3Not reported20.037.9Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.985
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.104
    group Description
    All analyses based on final DBL were descriptive only.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    param Type
    Odds Ratio (OR)
    param Value
    1.749
  2. ci Lower Limit
    0.825
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.647
    group Description
    All analyses based on final DBL were descriptive only.
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    param Type
    Odds Ratio (OR)
    param Value
    1.478
Complete source fields
analyses
  1. ci Lower Limit
    0.985
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.104
    group Description
    All analyses based on final DBL were descriptive only.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    param Type
    Odds Ratio (OR)
    param Value
    1.749
  2. ci Lower Limit
    0.825
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.647
    group Description
    All analyses based on final DBL were descriptive only.
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    param Type
    Odds Ratio (OR)
    param Value
    1.478
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        31.4
        upper Limit
        50.6
        value
        40.7
      2. group Id
        OG001
        lower Limit
        27.7
        upper Limit
        46.5
        value
        36.7
      3. group Id
        OG002
        lower Limit
        20.0
        upper Limit
        37.9
        value
        28.3
denoms
  1. counts
    1. group Id
      OG000
      value
      108
    2. group Id
      OG001
      value
      109
    3. group Id
      OG002
      value
      106
    units
    Participants
description
ORR as assessed by IRC per RECIST 1.1 was defined as the percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR).
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received cemiplimab plus platinum-based doublet chemotherapy
    id
    OG000
    title
    Part 1: Cemiplimab + Chemotherapy
  2. description
    Participants received cemiplimab plus platinum-based doublet chemotherapy and ipilimumab
    id
    OG001
    title
    Part 1: Cemiplimab+AbbrevChemo+Ipilimumab
  3. description
    Participants received platinum-based doublet chemotherapy
    id
    OG002
    title
    Part 1: Chemotherapy
param Type
NUMBER
population Description
Part 1 participants only
reporting Status
POSTED
time Frame
Up to 32 months
title
Part 1: Objective Response Rate (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