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NCT04194944 · OUTCOME

PFS 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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Baseline to Progressive Disease or Death from Any Cause Up to 31 Months

What was measured

PFS is defined as the time from randomization until the occurrence of documented disease progression by the BICR, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, or death from any cause in the absence of BICR-documented progressive disease.

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. Participants censored: TRT A: 98, TRT B:45.

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 Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Selpercatinib (TRT A)24.84Not reported17.31NAUpper limit of 95% confidence interval is not evaluable due to high censoring.
Pemetrexed and Platinum With or Without Pembrolizumab (TRT B)11.17Not reported8.7716.76Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.331
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.700
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.482
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.331
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.700
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.482
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        Upper limit of 95% confidence interval is not evaluable due to high censoring.
        group Id
        OG000
        lower Limit
        17.31
        upper Limit
        NA
        value
        24.84
      2. group Id
        OG001
        lower Limit
        8.77
        upper Limit
        16.76
        value
        11.17
denoms
  1. counts
    1. group Id
      OG000
      value
      159
    2. group Id
      OG001
      value
      102
    units
    Participants
description
PFS is defined as the time from randomization until the occurrence of documented disease progression by the BICR, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, or death from any cause in the absence of BICR-documented progressive disease.
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
MEDIAN
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. Participants censored: TRT A: 98, TRT B:45.
reporting Status
POSTED
time Frame
Baseline to Progressive Disease or Death from Any Cause Up to 31 Months
title
PFS by BICR (With or Without Pembrolizumab)
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice