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NCT04194944 · OUTCOME

Intracranial ORR: Percentage of Participants With Intracranial CR or PR Per RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Baseline through Central Nervous System (CNS) Progression or Death up to 31 Months

What was measured

Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RECIST 1.1 by BICR (with Pembrolizumab)

Analysis population: CNS Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment who had baseline CNS assessment and who had CNS metastasis at baseline.

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)21
Pemetrexed and Platinum With Pembrolizumab (TRT B)21

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Selpercatinib (TRT A)81Not reported58.194.6Not reported
Pemetrexed and Platinum With Pembrolizumab (TRT B)57.1Not reported34.078.2Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.8
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    12.8
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.1809
    param Type
    Odds Ratio (OR)
    param Value
    3.2
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    0.8
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    12.8
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.1809
    param Type
    Odds Ratio (OR)
    param Value
    3.2
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        58.1
        upper Limit
        94.6
        value
        81
      2. group Id
        OG001
        lower Limit
        34.0
        upper Limit
        78.2
        value
        57.1
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    2. group Id
      OG001
      value
      21
    units
    Participants
description
Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RECIST 1.1 by BICR (with Pembrolizumab)
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
NUMBER
population Description
CNS Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment who had baseline CNS assessment and who had CNS metastasis at baseline.
reporting Status
POSTED
time Frame
Baseline through Central Nervous System (CNS) Progression or Death up to 31 Months
title
Intracranial ORR: Percentage of Participants With Intracranial CR or PR Per RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 by BICR (With Pembrolizumab)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice