A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

Draft scope assessment: unclear. Attached because the study's own record names RET and describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

Intent to Treat (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: 80, TRT B: 34.

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primary · POSTED

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.

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.

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secondary · POSTED

DCR by BICR (with Pembrolizumab) is defined as the number of participants who achieve a BOR of complete response (CR), partial response (PR), or stable disease (SD) lasting 16 or more weeks divided by the total number of participants randomized to each treatment arm.

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.

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secondary · POSTED

DCR by BICR (with or without Pembrolizumab) is defined as the number of participants who achieve a BOR of CR, PR, or SD lasting 16 or more weeks divided by the total number of participants randomized to each treatment arm.

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secondary · POSTED

PFS2 is defined as the time from randomization to disease progression on the next line of treatment or death from any cause in the absence of observed disease progression.

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: 103; TRT B: 62

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secondary · POSTED

PFS2 is defined as the time from randomization to disease progression on the next line of treatment or death from any cause in the absence of observed disease progression.

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-non-small-cell-lung-cancer-gavreto-e020c86e
nct id: NCT04194944
trial label: A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
applicability: unclear
applicability note: Attached because the study's own record names RET and describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-e020c86e
nct id
NCT04194944
outcome key
om-0000
source section id
NCT04194944-om-0000
source outcome index
0
endpoint
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (With Pembrolizumab)
endpoint definition
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.
time origin
Baseline to Progressive Disease or Death from Any Cause Up to 31 Months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Intent to Treat (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: 80, TRT B: 34.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-e020c86e
nct id
NCT04194944
outcome key
om-0001
source section id
NCT04194944-om-0001
source outcome index
1
endpoint
PFS by BICR (With or Without Pembrolizumab)
endpoint definition
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.
time origin
Baseline to Progressive Disease or Death from Any Cause Up to 31 Months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-e020c86e
nct id
NCT04194944
outcome key
om-0002
source section id
NCT04194944-om-0002
source outcome index
2
endpoint
Percentage of Participant With Disease Control Rate (DCR) by BICR (With Pembrolizumab)
endpoint definition
DCR by BICR (with Pembrolizumab) is defined as the number of participants who achieve a BOR of complete response (CR), partial response (PR), or stable disease (SD) lasting 16 or more weeks divided by the total number of participants randomized to each treatment arm.
time origin
Baseline to Progressive Disease or Death from Any Cause Up to 31 Months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-e020c86e
nct id
NCT04194944
outcome key
om-0003
source section id
NCT04194944-om-0003
source outcome index
3
endpoint
Percentage of Participant With DCR by BICR (With or Without Pembrolizumab)
endpoint definition
DCR by BICR (with or without Pembrolizumab) is defined as the number of participants who achieve a BOR of CR, PR, or SD lasting 16 or more weeks divided by the total number of participants randomized to each treatment arm.
time origin
Baseline to Progressive Disease or Death from Any Cause Up to 31 Months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-e020c86e
nct id
NCT04194944
outcome key
om-0004
source section id
NCT04194944-om-0004
source outcome index
4
endpoint
PFS2 (With Pembrolizumab)
endpoint definition
PFS2 is defined as the time from randomization to disease progression on the next line of treatment or death from any cause in the absence of observed disease progression.
time origin
Baseline to Second Disease Progression or Death from Any Cause Up to 38 Months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
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: 103; TRT B: 62
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-e020c86e
nct id
NCT04194944
outcome key
om-0005
source section id
NCT04194944-om-0005
source outcome index
5
endpoint
PFS2 (With or Without Pembrolizumab)
endpoint definition
PFS2 is defined as the time from randomization to disease progression on the next line of treatment or death from any cause in the absence of observed disease progression.
time origin
Baseline to Second Disease Progression or Death from Any Cause Up to 38 Months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
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: 126; TRT B: 77
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-e020c86e
nct id
NCT04194944
outcome key
om-0000
arm key
OG000
arm label
Selpercatinib (TRT A)
regimen
160 mg Selpercatinib administered orally, BID continuously in 21-day cycles.
analyzed count
129
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04194944-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-e020c86e
nct id
NCT04194944
outcome key
om-0000
arm key
OG001
arm label
Pemetrexed and Platinum With Pembrolizumab (TRT B)
regimen
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.
analyzed count
83
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04194944-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-e020c86e
nct id
NCT04194944
outcome key
om-0001
arm key
OG000
arm label
Selpercatinib (TRT A)
regimen
160 mg Selpercatinib administered orally, BID continuously in 21-day cycles.
analyzed count
159
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04194944-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-e020c86e
nct id
NCT04194944
outcome key
om-0001
arm key
OG001
arm label
Pemetrexed and Platinum With or Without Pembrolizumab (TRT B)
regimen
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.
analyzed count
102
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04194944-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-e020c86e
nct id
NCT04194944
outcome key
om-0002
arm key
OG000
arm label
Selpercatinib (TRT A)
regimen
160 mg Selpercatinib administered orally BID continuously in 21-day cycles.
analyzed count
129
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04194944-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-e020c86e
nct id
NCT04194944
outcome key
om-0002
arm key
OG001
arm label
Pemetrexed and Platinum With Pembrolizumab (TRT B)
regimen
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.
analyzed count
83
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04194944-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-e020c86e
nct id
NCT04194944
outcome key
om-0003
arm key
OG000
arm label
Selpercatinib (TRT A)
regimen
160 mg Selpercatinib administered orally BID continuously in 21-day cycles.
analyzed count
159
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04194944-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-e020c86e
nct id
NCT04194944
outcome key
om-0003
arm key
OG001
arm label
Pemetrexed and Platinum With or Without Pembrolizumab (TRT B)
regimen
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.
analyzed count
102
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04194944-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-e020c86e
nct id
NCT04194944
outcome key
om-0004
arm key
OG000
arm label
Selpercatinib (TRT A)
regimen
160 mg Selpercatinib administered orally BID continuously in 21-day cycles.
analyzed count
129
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04194944-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-e020c86e
nct id
NCT04194944
outcome key
om-0004
arm key
OG001
arm label
Pemetrexed and Platinum With Pembrolizumab (TRT B)
regimen
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.
analyzed count
83
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04194944-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-e020c86e
nct id
NCT04194944
outcome key
om-0005
arm key
OG000
arm label
Selpercatinib (TRT A)
regimen
160 mg Selpercatinib administered orally BID continuously in 21-day cycles.
analyzed count
159
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04194944-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-e020c86e
nct id
NCT04194944
outcome key
om-0005
arm key
OG001
arm label
Pemetrexed and Platinum With or Without Pembrolizumab (TRT B)
regimen
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.
analyzed count
102
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04194944-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-e020c86e
nct id
NCT04194944
harm key
EG000
source section id
NCT04194944-ae
event group key
EG000
event group label
Selpercatinib (TRT A)
serious affected
55
serious at risk
158
other affected
156
other at risk
158
frequency threshold
5
collection period
Baseline Up to 38 Months
event definition
Safety population is defined as all participants who received study drug regardless of strata and as pre-specified, adverse events were collected for the TRT B treatment arm as a whole. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated").
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-e020c86e
nct id
NCT04194944
harm key
EG001
source section id
NCT04194944-ae
event group key
EG001
event group label
Carboplatin or Cisplatin+Pemetrexed+/-Pembrolizumab (TRT B)
serious affected
23
serious at risk
98
other affected
97
other at risk
98
frequency threshold
5
collection period
Baseline Up to 38 Months
event definition
Safety population is defined as all participants who received study drug regardless of strata and as pre-specified, adverse events were collected for the TRT B treatment arm as a whole. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated").
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice