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NCT04194944 · OUTCOME

ORR: Percentage of Participants With CR or PR by BICR (With or Without Pembrolizumab)

A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer · Source last updated 2025-10-21

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
Baseline through Disease Progression or Death Up to 31 Months

What was measured

ORR is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the total number of participants randomized to each treatment arm.

Analysis population: ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received.

Groups in this outcome

Selpercatinib (TRT A)

160 mg Selpercatinib administered orally BID continuously in 21-day cycles.

Pemetrexed and Platinum With or Without Pembrolizumab (TRT B)

Pemetrexed 500 mg/m2, IV on Day 1 Q3W plus investigator's choice of carboplatin AUC 5 (maximum dose 750 mg) IV or cisplatin 75mg/m2, IV on Day 1 Q3W for 4 cycles, plus investigator's choice with or without 200 mg pembrolizumab IV on Day 1 Q3W up to 35 cycles.

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

Analysis denominator · Participants

GroupSource count
Selpercatinib (TRT A)159
Pemetrexed and Platinum With or Without Pembrolizumab (TRT B)102

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Selpercatinib (TRT A)83.6Not reported77.089.0Not reported
Pemetrexed and Platinum With or Without Pembrolizumab (TRT B)62.7Not reported52.672.1Not reported

Source statistical analyses

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

  1. ci Lower Limit
    1.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.2
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0003
    param Type
    Odds Ratio (OR)
    param Value
    2.9
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    1.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.2
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0003
    param Type
    Odds Ratio (OR)
    param Value
    2.9
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        77.0
        upper Limit
        89.0
        value
        83.6
      2. group Id
        OG001
        lower Limit
        52.6
        upper Limit
        72.1
        value
        62.7
denoms
  1. counts
    1. group Id
      OG000
      value
      159
    2. group Id
      OG001
      value
      102
    units
    Participants
description
ORR is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the total number of participants randomized to each treatment arm.
dispersion Type
95% Confidence Interval
groups
  1. description
    160 mg Selpercatinib administered orally BID continuously in 21-day cycles.
    id
    OG000
    title
    Selpercatinib (TRT A)
  2. description
    Pemetrexed 500 mg/m2, IV on Day 1 Q3W plus investigator's choice of carboplatin AUC 5 (maximum dose 750 mg) IV or cisplatin 75mg/m2, IV on Day 1 Q3W for 4 cycles, plus investigator's choice with or without 200 mg pembrolizumab IV on Day 1 Q3W up to 35 cycles.
    id
    OG001
    title
    Pemetrexed and Platinum With or Without Pembrolizumab (TRT B)
param Type
NUMBER
population Description
ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received.
reporting Status
POSTED
time Frame
Baseline through Disease Progression or Death Up to 31 Months
title
ORR: Percentage of Participants With CR or PR by BICR (With or Without Pembrolizumab)
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice