Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)

Draft scope assessment: unclear. Attached because the study's own record names EGFR and names EGFR. The study record does not state Exon 19 Deletion, so it may describe a different alteration of the same gene. 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

To evaluate the safety and tolerability and defined the maximum tolerated dose (MTD) of sunvozertinib. DLT was evaluated in the DLT observation frame.

Patients in part A Dose Escalation Cohorts who met either or both criteria below were included in DLT analysis: * Patients who received the single dose and at least 80% of planned doses of DZD9008 in the first 28-day of repeated dosing and completed minimum required safety evaluations. * Patients who had at least one DLT reported during the DLT period. 1 patient in 100 mg dose level and 1 patient in 300 mg dose level received less than 80% of planned dose were excluded.

→

primary · POSTED

To evaluate anti-tumor activity of Sunvozertinib in advanced NSCLC patients with EGFR Exon20 insertion at defined dose(s) by assessment of Objective Response Rate (ORR).

Source null

→

secondary · POSTED

To assess anti-tumor efficacy of Sunvozertinib using additional endpoints.

Source null

→

secondary · POSTED

To assess anti-tumor efficacy of Sunvozertinib using additional endpoints.

Source null

→

secondary · POSTED

To determine the safety and tolerability of Sunvozertinib: Number of Participants With AEs, Number of Participants With SAEs. Using investigator reported AEs according to CTCAE and SAE criteria.

all patients had at least one dose of DZD9008

→

secondary · POSTED

To assess preliminary anti-tumor activity of sunvozertinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator. Confirmed ORR was defined as the percentage of patients achieving a CR (Complete Response) or PR (Partial Response) and was confirmed by subsequent tumor assessment at least 4 weeks within the study period. Confirmed DCR was defined as the proportion of patients with a best overall response of CR, PR, or SD. Patients who achieved a CR or PR must be confirmed by a subsequent tumor assessment at least 4 weeks within the study period. Patients who achieved a best overall response of SD must be confirmed by subsequent tumor assessment at least 35 days within the study period.

Only participants in Part A were presented here, while Part B were presented separately. Participants in Part A with baseline and at least one post-treatment tumor assessment were included in this analysis.

→

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-rybrevant-faspro-964accb6
nct id: NCT03974022
trial label: Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)
applicability: unclear
applicability note: Attached because the study's own record names EGFR and names EGFR. The study record does not state Exon 19 Deletion, so it may describe a different alteration of the same gene. 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: 15
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT03974022
outcome key
om-0000
source section id
NCT03974022-om-0000
source outcome index
0
endpoint
Part A Dose Escalation: Dose Limiting Toxicities (DLTs).
endpoint definition
To evaluate the safety and tolerability and defined the maximum tolerated dose (MTD) of sunvozertinib. DLT was evaluated in the DLT observation frame.
time origin
The DLT observation period is defined as the 28 days after the first multiple dose (up to 36 days from baseline).
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Patients in part A Dose Escalation Cohorts who met either or both criteria below were included in DLT analysis: * Patients who received the single dose and at least 80% of planned doses of DZD9008 in the first 28-day of repeated dosing and completed minimum required safety evaluations. * Patients who had at least one DLT reported during the DLT period. 1 patient in 100 mg dose level and 1 patient in 300 mg dose level received less than 80% of planned dose were excluded.
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-rybrevant-faspro-964accb6
nct id
NCT03974022
outcome key
om-0001
source section id
NCT03974022-om-0001
source outcome index
1
endpoint
Part B: Objective Response Rate (ORR) According to RECIST 1.1 by an Independent Review Committee (IRC).
endpoint definition
To evaluate anti-tumor activity of Sunvozertinib in advanced NSCLC patients with EGFR Exon20 insertion at defined dose(s) by assessment of Objective Response Rate (ORR).
time origin
through the study completion, an average of around 1 year for part B
analysis role
primary
reporting status
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT03974022
outcome key
om-0002
source section id
NCT03974022-om-0002
source outcome index
2
endpoint
Part B: DCR According to RECIST 1.1 Using Assessments Performed by an IRC; DCR Using Investigators Assessments According to RECIST 1.1
endpoint definition
To assess anti-tumor efficacy of Sunvozertinib using additional endpoints.
time origin
Through the study completion, an average of around 1 year for part B
analysis role
secondary
reporting status
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT03974022
outcome key
om-0003
source section id
NCT03974022-om-0003
source outcome index
3
endpoint
Part B: DoR, PFS According to RECIST 1.1 Using Assessments Performed by an IRC; DoR, PFS Using Investigators Assessments According to RECIST 1.1
endpoint definition
To assess anti-tumor efficacy of Sunvozertinib using additional endpoints.
time origin
Through the study completion, an average of around 1 year for part B
analysis role
secondary
reporting status
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
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT03974022
outcome key
om-0004
source section id
NCT03974022-om-0004
source outcome index
4
endpoint
Part B: AEs/SAEs
endpoint definition
To determine the safety and tolerability of Sunvozertinib: Number of Participants With AEs, Number of Participants With SAEs. Using investigator reported AEs according to CTCAE and SAE criteria.
time origin
Through the study completion, an average of around 1 year for part B
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
all patients had at least one dose of DZD9008
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-rybrevant-faspro-964accb6
nct id
NCT03974022
outcome key
om-0005
source section id
NCT03974022-om-0005
source outcome index
5
endpoint
Part A: Confirmed ORR and DCR by Investigator.
endpoint definition
To assess preliminary anti-tumor activity of sunvozertinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator. Confirmed ORR was defined as the percentage of patients achieving a CR (Complete Response) or PR (Partial Response) and was confirmed by subsequent tumor assessment at least 4 weeks within the study period. Confirmed DCR was defined as the proportion of patients with a best overall response of CR, PR, or SD. Patients who achieved a CR or PR must be confirmed by a subsequent tumor assessment at least 4 weeks within the study period. Patients who achieved a best overall response of SD must be confirmed by subsequent tumor assessment at least 35 days within the study period.
time origin
The study duration was from the initiation of sunvozertinib treatment until the study completion. The median study duration was 10 months, and the maximal study duration was 51.4 months for part A.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Only participants in Part A were presented here, while Part B were presented separately. Participants in Part A with baseline and at least one post-treatment tumor assessment were included in this analysis.
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-rybrevant-faspro-964accb6
nct id
NCT03974022
outcome key
om-0000
arm key
OG000
arm label
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
regimen
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03974022-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT03974022
outcome key
om-0000
arm key
OG001
arm label
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
regimen
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03974022-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT03974022
outcome key
om-0000
arm key
OG002
arm label
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
regimen
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03974022-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT03974022
outcome key
om-0000
arm key
OG003
arm label
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
regimen
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03974022-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT03974022
outcome key
om-0000
arm key
OG004
arm label
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
regimen
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03974022-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT03974022
outcome key
om-0001
arm key
OG000
arm label
Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg
regimen
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized to receive sunvozertinib 200 mg once daily continuously.
analyzed count
85
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03974022-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT03974022
outcome key
om-0001
arm key
OG001
arm label
Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg
regimen
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized ratio to receive sunvozertinib 300 mg once daily continuously.
analyzed count
107
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03974022-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT03974022
outcome key
om-0002
arm key
OG000
arm label
Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg
regimen
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive sunvozertinib 200 mg once daily continuously.
analyzed count
85
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03974022-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT03974022
outcome key
om-0002
arm key
OG001
arm label
Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg
regimen
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive sunvozertinib 300 mg once daily continuously.
analyzed count
107
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03974022-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT03974022
outcome key
om-0003
arm key
OG000
arm label
Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg
regimen
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized to receive sunvozertinib 200 mg once daily continuously.
analyzed count
85
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03974022-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT03974022
outcome key
om-0003
arm key
OG001
arm label
Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg
regimen
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized to receive sunvozertinib 300 mg once daily continuously.
analyzed count
107
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03974022-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT03974022
outcome key
om-0004
arm key
OG000
arm label
Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg
regimen
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized to receive sunvozertinib 200 mg once daily continuously.
analyzed count
91
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03974022-om-0004#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT03974022
harm key
EG000
source section id
NCT03974022-ae
event group key
EG000
event group label
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
event definition
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
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-rybrevant-faspro-964accb6
nct id
NCT03974022
harm key
EG001
source section id
NCT03974022-ae
event group key
EG001
event group label
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
serious affected
1
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
event definition
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
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-rybrevant-faspro-964accb6
nct id
NCT03974022
harm key
EG002
source section id
NCT03974022-ae
event group key
EG002
event group label
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
event definition
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
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-rybrevant-faspro-964accb6
nct id
NCT03974022
harm key
EG003
source section id
NCT03974022-ae
event group key
EG003
event group label
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
serious affected
4
serious at risk
7
other affected
7
other at risk
7
frequency threshold
5
collection period
Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
event definition
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
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-rybrevant-faspro-964accb6
nct id
NCT03974022
harm key
EG004
source section id
NCT03974022-ae
event group key
EG004
event group label
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
serious affected
2
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
event definition
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
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-rybrevant-faspro-964accb6
nct id
NCT03974022
harm key
EG005
source section id
NCT03974022-ae
event group key
EG005
event group label
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
serious affected
4
serious at risk
10
other affected
10
other at risk
10
frequency threshold
5
collection period
Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
event definition
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
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-rybrevant-faspro-964accb6
nct id
NCT03974022
harm key
EG006
source section id
NCT03974022-ae
event group key
EG006
event group label
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
serious affected
5
serious at risk
14
other affected
14
other at risk
14
frequency threshold
5
collection period
Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
event definition
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
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-rybrevant-faspro-964accb6
nct id
NCT03974022
harm key
EG007
source section id
NCT03974022-ae
event group key
EG007
event group label
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
serious affected
9
serious at risk
14
other affected
14
other at risk
14
frequency threshold
5
collection period
Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
event definition
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
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-rybrevant-faspro-964accb6
nct id
NCT03974022
harm key
EG008
source section id
NCT03974022-ae
event group key
EG008
event group label
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
serious affected
2
serious at risk
7
other affected
7
other at risk
7
frequency threshold
5
collection period
Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
event definition
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
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-rybrevant-faspro-964accb6
nct id
NCT03974022
harm key
EG009
source section id
NCT03974022-ae
event group key
EG009
event group label
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
serious affected
14
serious at risk
31
other affected
31
other at risk
31
frequency threshold
5
collection period
Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
event definition
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
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-rybrevant-faspro-964accb6
nct id
NCT03974022
harm key
EG010
source section id
NCT03974022-ae
event group key
EG010
event group label
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
serious affected
0
serious at risk
0
other affected
0
other at risk
0
frequency threshold
5
collection period
Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
event definition
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
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-rybrevant-faspro-964accb6
nct id
NCT03974022
harm key
EG011
source section id
NCT03974022-ae
event group key
EG011
event group label
Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
serious affected
0
serious at risk
5
other affected
5
other at risk
5
frequency threshold
5
collection period
Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
event definition
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
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