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NCT03409614 · OUTCOME

Part 1: Progression-free Survival (PFS) Per Independent Review Committee (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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Up to a maximum of 82.2 months

What was measured

PFS as assessed by IRC per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was defined as the time from randomization to the date of the first documented tumor progression, or death due to any cause, whichever occurred earlier.

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 months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy6.5Not reported6.28.3Not reported
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab6.4Not reported4.28.4Not reported
Part 1: Chemotherapy6.4Not reported5.97.2Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.581
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.065
    group Description
    All analyses based on final DBL were descriptive only.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.786
  2. ci Lower Limit
    0.588
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.085
    group Description
    All analyses based on final DBL were descriptive only.
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.798
Complete source fields
analyses
  1. ci Lower Limit
    0.581
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.065
    group Description
    All analyses based on final DBL were descriptive only.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.786
  2. ci Lower Limit
    0.588
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.085
    group Description
    All analyses based on final DBL were descriptive only.
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.798
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.2
        upper Limit
        8.3
        value
        6.5
      2. group Id
        OG001
        lower Limit
        4.2
        upper Limit
        8.4
        value
        6.4
      3. group Id
        OG002
        lower Limit
        5.9
        upper Limit
        7.2
        value
        6.4
denoms
  1. counts
    1. group Id
      OG000
      value
      108
    2. group Id
      OG001
      value
      109
    3. group Id
      OG002
      value
      106
    units
    Participants
description
PFS as assessed by IRC per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was defined as the time from randomization to the date of the first documented tumor progression, or death due to any cause, whichever occurred earlier.
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
MEDIAN
population Description
Part 1 participants only
reporting Status
POSTED
time Frame
Up to a maximum of 82.2 months
title
Part 1: Progression-free Survival (PFS) Per Independent Review Committee (IRC)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice