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NCT03088540 · OUTCOME

Objective Response Rate (ORR) Per IRC

Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2026-06-25

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 73.5 months

What was measured

ORR was defined as the percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) as assessed by IRC per RECIST 1.1.

Analysis population: FAS included all randomized participants.

Groups in this outcome

Cemiplimab

Participants received cemiplimab monotherapy

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
Cemiplimab357
Chemotherapy355

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cemiplimab42.3Not reported37.147.6Not reported
Chemotherapy21.4Not reported17.326.0Not reported

Source statistical analyses

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

  1. ci Lower Limit
    1.936
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.740
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    All analyses based on final DBL were descriptive only with p-values reported as nominal.
    param Type
    Odds Ratio (OR)
    param Value
    2.691
    statistical Method
    Stratified Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    1.936
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.740
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    All analyses based on final DBL were descriptive only with p-values reported as nominal.
    param Type
    Odds Ratio (OR)
    param Value
    2.691
    statistical Method
    Stratified Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        37.1
        upper Limit
        47.6
        value
        42.3
      2. group Id
        OG001
        lower Limit
        17.3
        upper Limit
        26.0
        value
        21.4
denoms
  1. counts
    1. group Id
      OG000
      value
      357
    2. group Id
      OG001
      value
      355
    units
    Participants
description
ORR was defined as the percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) as assessed by IRC per RECIST 1.1.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received cemiplimab monotherapy
    id
    OG000
    title
    Cemiplimab
  2. description
    Participants received platinum-based doublet chemotherapy
    id
    OG001
    title
    Chemotherapy
param Type
NUMBER
population Description
FAS included all randomized participants.
reporting Status
POSTED
time Frame
Up to 73.5 months
title
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