A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)

Draft scope assessment: unclear. Attached because the study's own record names RET. 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

The MTD is defined as the highest dose level at which none of the first 3 treated patients, or not more than 1 of the first 6 treated patients, experiences a DLT. A DLT is any adverse events that starts on or after first administration of study drug, as defined by National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. * Any Grade(G) ≥3 nonhematologic toxicity, excluding * G3 AST, ALT, and/or total bilirubin elevation for \<7 days. * G3 neutropenia \<7 days * G3 thrombocytopenia without clinically significant bleeding * G3 or G4 lymphopenia. * First occurrence of G3 or G4 electrolyte abnormalities * G3 fatigue, weakness, nausea; other manageable constitutional symptom * G3 or G4 vomiting or diarrhea that lasts for \<48hours with antiemetic/antidiarrheal medication in case of G3 and \<24 hours in case of G4 * G4 manageable constitutional symptom.

All Participants who received at least 1 or more doses of selpercatinib and had evaluable data for this outcome.

→

primary · POSTED

Phase 1: RP2D

All Participants who received at least 1 or more doses of selpercatinib and had evaluable data for this outcome.

→

primary · POSTED

Objective Response Rate was defined as the percentage of participants with best overall response of confirmed response (CR), or Partial response (PR). Response was confirmed by a repeat assessment no less than 28 days. * CR is defined as disappearance of all target lesions. * PR is defined as at least a 30% decrease in the sum of diameter (LD for non-nodal lesions and short axis diameter \[SAD\] for nodal lesions) of target lesions, taking as reference the baseline sum LD. ORR was assessed by independent review committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 95% confidence interval was calculated using Clopper-Pearson method.

All phase 2 participants who received at least 1 or more doses of selpercatinib and had evaluable data for this outcome.

→

secondary · POSTED

Phase 1: Number of Participants with a TRAE(s) is reported.

All Participants who received at least 1 or more doses of selpercatinib and had evaluable data for this outcome.

→

secondary · POSTED

Phase 1: Number of Participants With an Abnormal Laboratory Values

All Participants who received at least 1 or more doses of selpercatinib and had evaluable data for this outcome.

→

secondary · NOT_POSTED

Phase 2: ORR based on RECIST 1.1 or RANO, as Appropriate to Tumor Type

Source null

→

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-7b04bdb0
nct id: NCT03157128
trial label: A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)
applicability: unclear
applicability note: Attached because the study's own record names RET. 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: 16
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-7b04bdb0
nct id
NCT03157128
outcome key
om-0000
source section id
NCT03157128-om-0000
source outcome index
0
endpoint
Phase 1: Maximum Tolerated Dose (MTD)
endpoint definition
The MTD is defined as the highest dose level at which none of the first 3 treated patients, or not more than 1 of the first 6 treated patients, experiences a DLT. A DLT is any adverse events that starts on or after first administration of study drug, as defined by National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. * Any Grade(G) ≥3 nonhematologic toxicity, excluding * G3 AST, ALT, and/or total bilirubin elevation for \<7 days. * G3 neutropenia \<7 days * G3 thrombocytopenia without clinically significant bleeding * G3 or G4 lymphopenia. * First occurrence of G3 or G4 electrolyte abnormalities * G3 fatigue, weakness, nausea; other manageable constitutional symptom * G3 or G4 vomiting or diarrhea that lasts for \<48hours with antiemetic/antidiarrheal medication in case of G3 and \<24 hours in case of G4 * G4 manageable constitutional symptom.
time origin
Cycle 1 (cycle length = 28 days)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All Participants who received at least 1 or more doses of selpercatinib and had evaluable data for this outcome.
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-7b04bdb0
nct id
NCT03157128
outcome key
om-0001
source section id
NCT03157128-om-0001
source outcome index
1
endpoint
Phase 1: Recommended Phase 2 Dose (RP2D)
endpoint definition
Phase 1: RP2D
time origin
Cycle 1 (cycle length = 28 days)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All Participants who received at least 1 or more doses of selpercatinib and had evaluable data for this outcome.
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-7b04bdb0
nct id
NCT03157128
outcome key
om-0002
source section id
NCT03157128-om-0002
source outcome index
2
endpoint
Phase 2: Objective Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment
endpoint definition
Objective Response Rate was defined as the percentage of participants with best overall response of confirmed response (CR), or Partial response (PR). Response was confirmed by a repeat assessment no less than 28 days. * CR is defined as disappearance of all target lesions. * PR is defined as at least a 30% decrease in the sum of diameter (LD for non-nodal lesions and short axis diameter \[SAD\] for nodal lesions) of target lesions, taking as reference the baseline sum LD. ORR was assessed by independent review committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 95% confidence interval was calculated using Clopper-Pearson method.
time origin
Approximately for up to 7 years 8 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All phase 2 participants who received at least 1 or more doses of selpercatinib and had evaluable data for this outcome.
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-7b04bdb0
nct id
NCT03157128
outcome key
om-0003
source section id
NCT03157128-om-0003
source outcome index
3
endpoint
Phase 1: Number of Participants With a Treatment-Related Adverse Event(s) (TRAE[s])
endpoint definition
Phase 1: Number of Participants with a TRAE(s) is reported.
time origin
Up to 28 days
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All Participants who received at least 1 or more doses of selpercatinib and had evaluable data for this outcome.
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-7b04bdb0
nct id
NCT03157128
outcome key
om-0004
source section id
NCT03157128-om-0004
source outcome index
4
endpoint
Phase 1: Number of Participants With an Abnormal Laboratory Values
endpoint definition
Phase 1: Number of Participants With an Abnormal Laboratory Values
time origin
Up to 28 days
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All Participants who received at least 1 or more doses of selpercatinib and had evaluable data for this outcome.
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-7b04bdb0
nct id
NCT03157128
outcome key
om-0005
source section id
NCT03157128-om-0005
source outcome index
5
endpoint
Phase 2: Overall Response Rate (ORR) Based on RECIST 1.1 or RANO, as Appropriate to Tumor Type
endpoint definition
Phase 2: ORR based on RECIST 1.1 or RANO, as Appropriate to Tumor Type
time origin
Approximately for up to 9 years 8 months
analysis role
secondary
reporting status
NOT_POSTED
data cutoff
Source null
population note
Source null
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-7b04bdb0
nct id
NCT03157128
outcome key
om-0000
arm key
OG000
arm label
Phase 1 - Selpercatinib (All Participants)
regimen
All Phase 1 Participants who received Selpercatinib (20 mg - 240 mg) orally once daily (QD) or twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
analyzed count
827
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03157128-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-7b04bdb0
nct id
NCT03157128
outcome key
om-0001
arm key
OG000
arm label
Phase 1 - Selpercatinib (All Participants)
regimen
All Phase 1 Participants who received Selpercatinib (20 mg - 240 mg) orally once daily (QD) or twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
analyzed count
827
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03157128-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-7b04bdb0
nct id
NCT03157128
outcome key
om-0002
arm key
OG000
arm label
Phase 2, Cohort 1: RET Fusion Solid Tumor
regimen
Participants with Rearranged during transfection (RET) Fusion solid tumor progressed on/intolerant to standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
analyzed count
307
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03157128-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-7b04bdb0
nct id
NCT03157128
outcome key
om-0002
arm key
OG001
arm label
Phase 2, Cohort 2: RET Fusion Solid Tumor Without Standard Therapy
regimen
Participants with RET Fusion solid tumor without standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
analyzed count
74
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03157128-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-7b04bdb0
nct id
NCT03157128
outcome key
om-0002
arm key
OG002
arm label
Phase 2, Cohort 3: RET Mutant MTC
regimen
Participants with RET mutant medullary thyroid cancer (MTC) progressed on/intolerant to standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
analyzed count
143
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03157128-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-7b04bdb0
nct id
NCT03157128
outcome key
om-0002
arm key
OG003
arm label
Phase 2, Cohort 4: RET Mutant MTC Without Standard Therapy
regimen
Participants with RET mutant MTC without prior standard first line therapy or other kinase inhibitor(s) with anti-RET activity received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
analyzed count
116
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03157128-om-0002#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-7b04bdb0
nct id
NCT03157128
outcome key
om-0002
arm key
OG004
arm label
Phase 2, Cohort 5: Advanced RET Altered Solid Tumor
regimen
Participants with RET altered solid tumor (cohorts 1-4, disease not measurable; MTC not eligible for Cohort 3 or 4; MTC syndrome spectrum cancer; circulating free tumor DNA \[cfDNA+\] for RET alteration not known to be present in tumor) received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
analyzed count
201
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03157128-om-0002#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-7b04bdb0
nct id
NCT03157128
outcome key
om-0002
arm key
OG005
arm label
Phase 2, Cohort 6: RET Inhibitor-Discontinued Participants
regimen
Participants otherwise eligible for Cohorts 1-5 who discontinued other RET inhibitors received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03157128-om-0002#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-7b04bdb0
nct id
NCT03157128
outcome key
om-0003
arm key
OG000
arm label
Phase 1: 20 mg Selpercatinib QD
regimen
Participants received Selpercatinib 20 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03157128-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-7b04bdb0
nct id
NCT03157128
outcome key
om-0003
arm key
OG001
arm label
Phase 1: 20 mg Selpercatinib BID
regimen
Participants received Selpercatinib 20 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03157128-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-7b04bdb0
nct id
NCT03157128
outcome key
om-0003
arm key
OG002
arm label
Phase 1: 40 mg Selpercatinib BID
regimen
Participants received Selpercatinib 40 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03157128-om-0003#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-7b04bdb0
nct id
NCT03157128
outcome key
om-0003
arm key
OG003
arm label
Phase 1: 60 mg Selpercatinib BID
regimen
Participants received Selpercatinib 60 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03157128-om-0003#groups/OG003

harms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-gavreto-7b04bdb0
nct id
NCT03157128
harm key
EG000
source section id
NCT03157128-ae
event group key
EG000
event group label
Phase 1: 20 mg Selpercatinib QD
serious affected
4
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
Phase 1: Up to 28 days; Phase 2: Up to 7 years 8 months
event definition
All Participants who received at least 1 or more doses of Selpercatinib.
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-7b04bdb0
nct id
NCT03157128
harm key
EG001
source section id
NCT03157128-ae
event group key
EG001
event group label
Phase 1: 20 mg Selpercatinib BID
serious affected
8
serious at risk
10
other affected
10
other at risk
10
frequency threshold
5
collection period
Phase 1: Up to 28 days; Phase 2: Up to 7 years 8 months
event definition
All Participants who received at least 1 or more doses of Selpercatinib.
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-7b04bdb0
nct id
NCT03157128
harm key
EG002
source section id
NCT03157128-ae
event group key
EG002
event group label
Phase 1: 40 mg Selpercatinib BID
serious affected
9
serious at risk
16
other affected
16
other at risk
16
frequency threshold
5
collection period
Phase 1: Up to 28 days; Phase 2: Up to 7 years 8 months
event definition
All Participants who received at least 1 or more doses of Selpercatinib.
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-7b04bdb0
nct id
NCT03157128
harm key
EG003
source section id
NCT03157128-ae
event group key
EG003
event group label
Phase 1: 60 mg Selpercatinib BID
serious affected
7
serious at risk
12
other affected
12
other at risk
12
frequency threshold
5
collection period
Phase 1: Up to 28 days; Phase 2: Up to 7 years 8 months
event definition
All Participants who received at least 1 or more doses of Selpercatinib.
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-7b04bdb0
nct id
NCT03157128
harm key
EG004
source section id
NCT03157128-ae
event group key
EG004
event group label
Phase 1: 160 mg Selpercatinib QD
serious affected
1
serious at risk
1
other affected
1
other at risk
1
frequency threshold
5
collection period
Phase 1: Up to 28 days; Phase 2: Up to 7 years 8 months
event definition
All Participants who received at least 1 or more doses of Selpercatinib.
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-7b04bdb0
nct id
NCT03157128
harm key
EG005
source section id
NCT03157128-ae
event group key
EG005
event group label
Phase 1: 80 mg Selpercatinib BID
serious affected
13
serious at risk
20
other affected
20
other at risk
20
frequency threshold
5
collection period
Phase 1: Up to 28 days; Phase 2: Up to 7 years 8 months
event definition
All Participants who received at least 1 or more doses of Selpercatinib.
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-7b04bdb0
nct id
NCT03157128
harm key
EG006
source section id
NCT03157128-ae
event group key
EG006
event group label
Phase 1: 120 mg Selpercatinib BID
serious affected
11
serious at risk
19
other affected
19
other at risk
19
frequency threshold
5
collection period
Phase 1: Up to 28 days; Phase 2: Up to 7 years 8 months
event definition
All Participants who received at least 1 or more doses of Selpercatinib.
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-7b04bdb0
nct id
NCT03157128
harm key
EG007
source section id
NCT03157128-ae
event group key
EG007
event group label
Phase 1: 160 mg Selpercatinib BID
serious affected
380
serious at risk
764
other affected
764
other at risk
764
frequency threshold
5
collection period
Phase 1: Up to 28 days; Phase 2: Up to 7 years 8 months
event definition
All Participants who received at least 1 or more doses of Selpercatinib.
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-7b04bdb0
nct id
NCT03157128
harm key
EG008
source section id
NCT03157128-ae
event group key
EG008
event group label
Phase 1: 200 mg Selpercatinib BID
serious affected
3
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Phase 1: Up to 28 days; Phase 2: Up to 7 years 8 months
event definition
All Participants who received at least 1 or more doses of Selpercatinib.
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-7b04bdb0
nct id
NCT03157128
harm key
EG009
source section id
NCT03157128-ae
event group key
EG009
event group label
Phase 1: 240 mg Selpercatinib BID
serious affected
3
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
Phase 1: Up to 28 days; Phase 2: Up to 7 years 8 months
event definition
All Participants who received at least 1 or more doses of Selpercatinib.
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-7b04bdb0
nct id
NCT03157128
harm key
EG010
source section id
NCT03157128-ae
event group key
EG010
event group label
Phase 2, Cohort 1: RET Fusion Solid Tumor
serious affected
187
serious at risk
307
other affected
307
other at risk
307
frequency threshold
5
collection period
Phase 1: Up to 28 days; Phase 2: Up to 7 years 8 months
event definition
All Participants who received at least 1 or more doses of Selpercatinib.
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-7b04bdb0
nct id
NCT03157128
harm key
EG011
source section id
NCT03157128-ae
event group key
EG011
event group label
Phase 2, Cohort 2: RET Fusion Solid Tumor Without Standard Therapy
serious affected
39
serious at risk
74
other affected
74
other at risk
74
frequency threshold
5
collection period
Phase 1: Up to 28 days; Phase 2: Up to 7 years 8 months
event definition
All Participants who received at least 1 or more doses of Selpercatinib.
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