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NCT04194944 · OUTCOME

Duration of Response (DoR) by BICR (With 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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause Up to 31 Months

What was measured

DoR was defined as the time from the date that measurement criteria for CR or PR (whichever is first recorded) were first met until the first date that disease was recurrent or documented disease progression was observed, or the date of death from any cause in the absence of documented disease progression or recurrence. The DOR according to both BICR and investigator-assessed BOR was evaluated per RECIST 1.1 criteria.

Analysis population: ITT Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment. Participants censored: TRT A:74; TRT B: 25.

Groups in this outcome

Selpercatinib (TRT A)

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

Pemetrexed and Platinum With 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 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)108
Pemetrexed and Platinum With Pembrolizumab (TRT B)54

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Selpercatinib (TRT A)24.18Not reported17.94NAUpper limit of 95% confidence interval not available due to high censoring.
Pemetrexed and Platinum With Pembrolizumab (TRT B)11.47Not reported9.6623.26Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.224
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.633
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.377
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.224
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.633
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.377
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        Upper limit of 95% confidence interval not available due to high censoring.
        group Id
        OG000
        lower Limit
        17.94
        upper Limit
        NA
        value
        24.18
      2. group Id
        OG001
        lower Limit
        9.66
        upper Limit
        23.26
        value
        11.47
denoms
  1. counts
    1. group Id
      OG000
      value
      108
    2. group Id
      OG001
      value
      54
    units
    Participants
description
DoR was defined as the time from the date that measurement criteria for CR or PR (whichever is first recorded) were first met until the first date that disease was recurrent or documented disease progression was observed, or the date of death from any cause in the absence of documented disease progression or recurrence. The DOR according to both BICR and investigator-assessed BOR was evaluated per RECIST 1.1 criteria.
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 200 mg pembrolizumab IV on Day 1 Q3W up to 35 cycles.
    id
    OG001
    title
    Pemetrexed and Platinum With Pembrolizumab (TRT B)
param Type
MEDIAN
population Description
ITT Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment. Participants censored: TRT A:74; TRT B: 25.
reporting Status
POSTED
time Frame
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause Up to 31 Months
title
Duration of Response (DoR) by BICR (With Pembrolizumab)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice