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NCT03409614 · OUTCOME

Part 2: BOR 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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 32 months

What was measured

BOR was defined as the best overall response as determined by the IRC per RECIST 1.1, between the date of randomization and the date of first documented tumor progression or the date of subsequent anti-cancer therapy, whichever occurred earlier.

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

CR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Cemiplimab + Chemotherapy20Not reportedNot reportedNot reportedNot reported
Part 2: Placebo + Chemotherapy0Not reportedNot reportedNot reportedNot reported

PR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Cemiplimab + Chemotherapy116Not reportedNot reportedNot reportedNot reported
Part 2: Placebo + Chemotherapy34Not reportedNot reportedNot reportedNot reported

SD

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Cemiplimab + Chemotherapy121Not reportedNot reportedNot reportedNot reported
Part 2: Placebo + Chemotherapy75Not reportedNot reportedNot reportedNot reported

PD

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Cemiplimab + Chemotherapy22Not reportedNot reportedNot reportedNot reported
Part 2: Placebo + Chemotherapy24Not reportedNot reportedNot reportedNot reported

Non-CR/Non-PD

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Cemiplimab + Chemotherapy3Not reportedNot reportedNot reportedNot reported
Part 2: Placebo + Chemotherapy1Not reportedNot reportedNot reportedNot reported

NE

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Cemiplimab + Chemotherapy30Not reportedNot reportedNot reportedNot reported
Part 2: Placebo + Chemotherapy20Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        0
      title
      CR
    2. measurements
      1. group Id
        OG000
        value
        116
      2. group Id
        OG001
        value
        34
      title
      PR
    3. measurements
      1. group Id
        OG000
        value
        121
      2. group Id
        OG001
        value
        75
      title
      SD
    4. measurements
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        24
      title
      PD
    5. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
      title
      Non-CR/Non-PD
    6. measurements
      1. group Id
        OG000
        value
        30
      2. group Id
        OG001
        value
        20
      title
      NE
denoms
  1. counts
    1. group Id
      OG000
      value
      312
    2. group Id
      OG001
      value
      154
    units
    Participants
description
BOR was defined as the best overall response as determined by the IRC per RECIST 1.1, between the date of randomization and the date of first documented tumor progression or the date of subsequent anti-cancer therapy, whichever occurred earlier.
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
COUNT_OF_PARTICIPANTS
population Description
Part 2 participants only
reporting Status
POSTED
time Frame
Up to 32 months
title
Part 2: BOR Per IRC
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice