DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer

Draft scope assessment: unclear. Attached because the study's own record names HER2 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

The Objective Response Rate (ORR) was the defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by independent central review (ICR) committee based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on ICR is reported.

Objective response rate was assessed in the Full Analysis Set at data cut-off date of 03 December 2021.

→

secondary · POSTED

The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigator assessment based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on investigator assessment is reported.

Objective response rate was assessed in the Full Analysis Set at data cut-off date of 03 May 2021.

→

secondary · POSTED

Duration of Response (DoR) was defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR in participants with confirmed CR/PR based on independent central review and investigator assessment is reported.

Duration of Response (DoR) was assessed in the Full Analysis Set of participants with confirmed CR/PR at data cut-off date of 03 May 2021.

→

secondary · POSTED

Progression-free survival (PFS) was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. PFS based on independent central review and investigator assessment is reported.

Progression-free survival (PFS) was assessed in the Full Analysis Set at data cut-off date of 03 May 2021.

→

secondary · POSTED

Overall survival (OS) was defined as the time from the date of first dose of study drug to the date of death due to any cause.

Overall survival (OS) was assessed in the Full Analysis Set at data cut-off date of 03 May 2021.

→

secondary · POSTED

Disease Control Rate (DCR) was defined as the percentage of participants who achieved a best overall response of CR, PR, or stable disease (SD) during study treatment. Confirmation of CR/PR was required. DCR based on independent central review and investigator assessment is reported.

Disease control rate was assessed in the Full Analysis Set at data cut-off date of 03 May 2021.

→

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-hyrnuo-0eb65740
nct id: NCT03505710
trial label: DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer
applicability: unclear
applicability note: Attached because the study's own record names HER2 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: 3
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-hyrnuo-0eb65740
nct id
NCT03505710
outcome key
om-0000
source section id
NCT03505710-om-0000
source outcome index
0
endpoint
Percentage of Participants With Objective Response Rate (ORR) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)
endpoint definition
The Objective Response Rate (ORR) was the defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by independent central review (ICR) committee based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on ICR is reported.
time origin
From screening, up to 36 months (data cut-off)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Objective response rate was assessed in the Full Analysis Set at data cut-off date of 03 December 2021.
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-hyrnuo-0eb65740
nct id
NCT03505710
outcome key
om-0001
source section id
NCT03505710-om-0001
source outcome index
1
endpoint
Percentage of Participants With Objective Response Rate (ORR) Based on Investigator Assessment Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)
endpoint definition
The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigator assessment based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on investigator assessment is reported.
time origin
From screening, up to 36 months (data cut-off)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Objective response rate was assessed in the Full Analysis Set at data cut-off date of 03 May 2021.
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-hyrnuo-0eb65740
nct id
NCT03505710
outcome key
om-0002
source section id
NCT03505710-om-0002
source outcome index
2
endpoint
Duration of Response (DoR) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)
endpoint definition
Duration of Response (DoR) was defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR in participants with confirmed CR/PR based on independent central review and investigator assessment is reported.
time origin
From screening to documented tumor progression or death from any cause, up to 36 months (data cut-off)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Duration of Response (DoR) was assessed in the Full Analysis Set of participants with confirmed CR/PR at data cut-off date of 03 May 2021.
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-hyrnuo-0eb65740
nct id
NCT03505710
outcome key
om-0003
source section id
NCT03505710-om-0003
source outcome index
3
endpoint
Progression-Free Survival (PFS) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)
endpoint definition
Progression-free survival (PFS) was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. PFS based on independent central review and investigator assessment is reported.
time origin
From date of enrollment to first objective radiographic tumor progression or death from any cause,, up to 36 months (data cut-off)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Progression-free survival (PFS) was assessed in the Full Analysis Set at data cut-off date of 03 May 2021.
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-hyrnuo-0eb65740
nct id
NCT03505710
outcome key
om-0004
source section id
NCT03505710-om-0004
source outcome index
4
endpoint
Overall Survival (OS) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)
endpoint definition
Overall survival (OS) was defined as the time from the date of first dose of study drug to the date of death due to any cause.
time origin
From date of enrollment to death from any cause, up to 36 months (data cut-off)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Overall survival (OS) was assessed in the Full Analysis Set at data cut-off date of 03 May 2021.
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-hyrnuo-0eb65740
nct id
NCT03505710
outcome key
om-0005
source section id
NCT03505710-om-0005
source outcome index
5
endpoint
Percentage of Participants With Disease Control Rate (DCR) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)
endpoint definition
Disease Control Rate (DCR) was defined as the percentage of participants who achieved a best overall response of CR, PR, or stable disease (SD) during study treatment. Confirmation of CR/PR was required. DCR based on independent central review and investigator assessment is reported.
time origin
From first dose, up to 36 months (data cut-off)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Disease control rate was assessed in the Full Analysis Set at data cut-off date of 03 May 2021.
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-hyrnuo-0eb65740
nct id
NCT03505710
outcome key
om-0000
arm key
OG000
arm label
Cohort 1: HER2 Overexpressing
regimen
Participants with HER2-overexpressing(immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
analyzed count
49
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03505710-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-hyrnuo-0eb65740
nct id
NCT03505710
outcome key
om-0000
arm key
OG001
arm label
Cohort 1a: HER2 Overexpressing
regimen
Participants with HER2-overexpressing (immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
analyzed count
41
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03505710-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-hyrnuo-0eb65740
nct id
NCT03505710
outcome key
om-0000
arm key
OG002
arm label
Cohort 2: HER2 Mutated
regimen
Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
analyzed count
91
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03505710-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-hyrnuo-0eb65740
nct id
NCT03505710
outcome key
om-0001
arm key
OG000
arm label
Cohort 1: HER2 Overexpressing
regimen
Participants with HER2-overexpressing(immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
analyzed count
49
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03505710-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-hyrnuo-0eb65740
nct id
NCT03505710
outcome key
om-0001
arm key
OG001
arm label
Cohort 1a: HER2 Overexpressing
regimen
Participants with HER2-overexpressing (immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
analyzed count
41
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03505710-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-hyrnuo-0eb65740
nct id
NCT03505710
outcome key
om-0001
arm key
OG002
arm label
Cohort 2: HER2 Mutated
regimen
Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
analyzed count
91
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03505710-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-hyrnuo-0eb65740
nct id
NCT03505710
outcome key
om-0002
arm key
OG000
arm label
Cohort 1: HER2 Overexpressing
regimen
Participants with HER2-overexpressing(immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03505710-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-hyrnuo-0eb65740
nct id
NCT03505710
outcome key
om-0002
arm key
OG001
arm label
Cohort 1a: HER2 Overexpressing
regimen
Participants with HER2-overexpressing (immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03505710-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-hyrnuo-0eb65740
nct id
NCT03505710
outcome key
om-0002
arm key
OG002
arm label
Cohort 2: HER2 Mutated
regimen
Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
analyzed count
50
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03505710-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-hyrnuo-0eb65740
nct id
NCT03505710
outcome key
om-0003
arm key
OG000
arm label
Cohort 1: HER2 Overexpressing
regimen
Participants with HER2-overexpressing(immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
analyzed count
49
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03505710-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-hyrnuo-0eb65740
nct id
NCT03505710
outcome key
om-0003
arm key
OG001
arm label
Cohort 1a: HER2 Overexpressing
regimen
Participants with HER2-overexpressing (immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
analyzed count
41
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03505710-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-hyrnuo-0eb65740
nct id
NCT03505710
outcome key
om-0003
arm key
OG002
arm label
Cohort 2: HER2 Mutated
regimen
Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
analyzed count
91
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03505710-om-0003#groups/OG002

harms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-hyrnuo-0eb65740
nct id
NCT03505710
harm key
EG000
source section id
NCT03505710-ae
event group key
EG000
event group label
Cohort 1: HER2 Overexpressing
serious affected
28
serious at risk
49
other affected
46
other at risk
49
frequency threshold
5
collection period
Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months.
event definition
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
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-hyrnuo-0eb65740
nct id
NCT03505710
harm key
EG001
source section id
NCT03505710-ae
event group key
EG001
event group label
Cohort 1a: HER2 Overexpressing
serious affected
18
serious at risk
41
other affected
41
other at risk
41
frequency threshold
5
collection period
Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months.
event definition
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
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-hyrnuo-0eb65740
nct id
NCT03505710
harm key
EG002
source section id
NCT03505710-ae
event group key
EG002
event group label
Cohort 2: HER2 Mutated
serious affected
40
serious at risk
91
other affected
91
other at risk
91
frequency threshold
5
collection period
Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months.
event definition
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
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