TriangleNCT04579380 · STUDY IN CONTEXT
Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations
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
Confirmed ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version (v)1.1 as assessed by investigator and was considered as confirmed when subsequent response was at least 4 weeks after initial response. As per RECIST v1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeter (mm). PR: at least a greater than or equal to (\>=)30 % decrease in the sum of diameters (SOD) of target lesions (longest for non-nodal target lesions and the short axes for nodal target lesions), taking as reference the baseline sum diameters. Disease progression (PD): at least \>=20% relative increase in SOD of target lesion taking as reference the smallest sum on study (including baseline sum if that is the smallest on study).
DCR was defined as the percentage of participants with confirmed CR, PR, or stable disease (SD or non-CR/non-PD) according to RECIST v1.1 as assessed by investigator. As per RECIST v1.1, CR: disappearance of all target (T) lesions and non-target (NT) lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least \>=30 % decrease in the SOD of target lesions (longest for non-nodal target lesions and the short axes for nodal target lesions), taking as reference the baseline sum diameters. PD: at least \>=20% relative increase in SOD of target lesions taking as reference the smallest sum on study (including baseline sum if that is the smallest on study). SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD while on study and cannot have met criteria for PD previously.
DOR: time from first documentation of confirmed CR/PR to first documentation of PD according to RECIST v1.1 or death from any cause, whichever occurred earlier. Per RECIST v1.1, CR: disappearance of all T/NT lesions(L). Any pathological lymph nodes (whether T/NT) must have reduction in short axis to \<10 mm. PR: at least \>=30 % decrease in SOD of TL, taking reference baseline sum diameters. PD: at least \>=20% relative increase in SOD of TL taking reference smallest sum on study. Participants who do not have PD \& were still on study at time of an analysis/ who have started new anticancer treatment/discontinue prior to documentation of PD were censored at date of last adequate response assessment documenting absence of PD. Participants who had PD/death occurred after two/more consecutive missing scheduled response assessments were censored at date of last adequate response assessment of CR, PR, SD,/non-CR/non-PD. Kaplan-Meier method was used for evaluation.
PFS was defined as time from the date of treatment initiation to date of PD as per RECIST v1.1 or death from any cause, whichever occurred first . As per RECIST v1.1, PD: least \>=20% relative increase in SOD of target lesions taking as reference the smallest sum on study (including baseline sum if that is smallest on study). Participants who do not have PD and were still on study at time of an analysis/ who have started new anticancer treatment/discontinue prior to documentation of PD were censored at date of last adequate response assessment documenting absence of PD. Participants who had PD or death occurred after two or more consecutive missing scheduled response assessments were censored at date of last adequate response assessment of CR, PR, SD,/non-CR/non-PD. Kaplan-Meier method was used for evaluation.
OS was defined as the time from treatment initiation to death due to any cause. For a participant who was not known to have died by the end of study follow-up, observation of OS was censored on the date the participant was last known to be alive (i.e., the date of last contact). Participants lacking data beyond the day of treatment initiation were censored on the date of treatment initiation (i.e., OS duration of 1 day). Kaplan-Meier method was used for evaluation.
An AE was any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment.
Reported safety
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-hernexeos-15f55fd1
- nct id
- NCT04579380
- trial label
- Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations
- 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
- 9
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-hernexeos-15f55fd1
- nct id
- NCT04579380
- outcome key
- om-0000
- source section id
- NCT04579380-om-0000
- source outcome index
- 0
- endpoint
- Confirmed Objective Response Rate (cORR) as Assessed by Investigator
- endpoint definition
- Confirmed ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version (v)1.1 as assessed by investigator and was considered as confirmed when subsequent response was at least 4 weeks after initial response. As per RECIST v1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeter (mm). PR: at least a greater than or equal to (\>=)30 % decrease in the sum of diameters (SOD) of target lesions (longest for non-nodal target lesions and the short axes for nodal target lesions), taking as reference the baseline sum diameters. Disease progression (PD): at least \>=20% relative increase in SOD of target lesion taking as reference the smallest sum on study (including baseline sum if that is the smallest on study).
- time origin
- From the first dose of study treatment until the first documented CR or PR on or before the first documented PD or new anti-cancer therapies or death, whichever occurred first (up to 28.3 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The Response-Evaluable analysis set includes all participants with measurable disease who meet the following 3 criteria: (1) had a baseline disease assessment, (2) received study treatment, and (3) had post-baseline disease assessment or discontinued treatment due to documented disease progression or clinical progression.
- 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-hernexeos-15f55fd1
- nct id
- NCT04579380
- outcome key
- om-0001
- source section id
- NCT04579380-om-0001
- source outcome index
- 1
- endpoint
- Confirmed Disease Control Rate (DCR) as Assessed by Investigator
- endpoint definition
- DCR was defined as the percentage of participants with confirmed CR, PR, or stable disease (SD or non-CR/non-PD) according to RECIST v1.1 as assessed by investigator. As per RECIST v1.1, CR: disappearance of all target (T) lesions and non-target (NT) lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least \>=30 % decrease in the SOD of target lesions (longest for non-nodal target lesions and the short axes for nodal target lesions), taking as reference the baseline sum diameters. PD: at least \>=20% relative increase in SOD of target lesions taking as reference the smallest sum on study (including baseline sum if that is the smallest on study). SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD while on study and cannot have met criteria for PD previously.
- time origin
- From the first dose study treatment until PD or death, whichever occurred first (approximately 52.7 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-hernexeos-15f55fd1
- nct id
- NCT04579380
- outcome key
- om-0002
- source section id
- NCT04579380-om-0002
- source outcome index
- 2
- endpoint
- Duration of Response (DOR) as Assessed by Investigator
- endpoint definition
- DOR: time from first documentation of confirmed CR/PR to first documentation of PD according to RECIST v1.1 or death from any cause, whichever occurred earlier. Per RECIST v1.1, CR: disappearance of all T/NT lesions(L). Any pathological lymph nodes (whether T/NT) must have reduction in short axis to \<10 mm. PR: at least \>=30 % decrease in SOD of TL, taking reference baseline sum diameters. PD: at least \>=20% relative increase in SOD of TL taking reference smallest sum on study. Participants who do not have PD \& were still on study at time of an analysis/ who have started new anticancer treatment/discontinue prior to documentation of PD were censored at date of last adequate response assessment documenting absence of PD. Participants who had PD/death occurred after two/more consecutive missing scheduled response assessments were censored at date of last adequate response assessment of CR, PR, SD,/non-CR/non-PD. Kaplan-Meier method was used for evaluation.
- time origin
- From the first documented CR or PR until the first documentation of PD or death or censoring date, whichever occurred first (approximately 52.7 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-hernexeos-15f55fd1
- nct id
- NCT04579380
- outcome key
- om-0003
- source section id
- NCT04579380-om-0003
- source outcome index
- 3
- endpoint
- Progression-Free Survival (PFS) as Assessed by Investigator
- endpoint definition
- PFS was defined as time from the date of treatment initiation to date of PD as per RECIST v1.1 or death from any cause, whichever occurred first . As per RECIST v1.1, PD: least \>=20% relative increase in SOD of target lesions taking as reference the smallest sum on study (including baseline sum if that is smallest on study). Participants who do not have PD and were still on study at time of an analysis/ who have started new anticancer treatment/discontinue prior to documentation of PD were censored at date of last adequate response assessment documenting absence of PD. Participants who had PD or death occurred after two or more consecutive missing scheduled response assessments were censored at date of last adequate response assessment of CR, PR, SD,/non-CR/non-PD. Kaplan-Meier method was used for evaluation.
- time origin
- From the first documented CR or PR until the first documentation of PD or death or censoring date, whichever occurred first (approximately 52.7 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-hernexeos-15f55fd1
- nct id
- NCT04579380
- outcome key
- om-0004
- source section id
- NCT04579380-om-0004
- source outcome index
- 4
- endpoint
- Overall Survival (OS)
- endpoint definition
- OS was defined as the time from treatment initiation to death due to any cause. For a participant who was not known to have died by the end of study follow-up, observation of OS was censored on the date the participant was last known to be alive (i.e., the date of last contact). Participants lacking data beyond the day of treatment initiation were censored on the date of treatment initiation (i.e., OS duration of 1 day). Kaplan-Meier method was used for evaluation.
- time origin
- From date of start of study treatment until date of death or censoring date (approximately 52.7 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-hernexeos-15f55fd1
- nct id
- NCT04579380
- outcome key
- om-0005
- source section id
- NCT04579380-om-0005
- source outcome index
- 5
- endpoint
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)
- endpoint definition
- An AE was any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment.
- time origin
- From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 52.7 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-hernexeos-15f55fd1
- nct id
- NCT04579380
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Tucatinib+Trastuzumab (Cohort 1)
- regimen
- Participants with cervical cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04579380-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-hernexeos-15f55fd1
- nct id
- NCT04579380
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Tucatinib+Trastuzumab (Cohort 2)
- regimen
- Participants with uterine cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
- analyzed count
- 30
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04579380-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-hernexeos-15f55fd1
- nct id
- NCT04579380
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Tucatinib+Trastuzumab (Cohort 3)
- regimen
- Participants with biliary tract cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
- analyzed count
- 30
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04579380-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-hernexeos-15f55fd1
- nct id
- NCT04579380
- outcome key
- om-0000
- arm key
- OG003
- arm label
- Tucatinib+Trastuzumab (Cohort 4)
- regimen
- Participants with urothelial cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
- analyzed count
- 25
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04579380-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-hernexeos-15f55fd1
- nct id
- NCT04579380
- outcome key
- om-0000
- arm key
- OG004
- arm label
- Tucatinib+Trastuzumab (Cohort 5)
- regimen
- Participants with NSCLC with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04579380-om-0000#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-hernexeos-15f55fd1
- nct id
- NCT04579380
- outcome key
- om-0000
- arm key
- OG005
- arm label
- Tucatinib+Trastuzumab (Cohort 6)
- regimen
- Participants with solid tumor types (except breast, gastric or GEC, and CRC) with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
- analyzed count
- 31
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04579380-om-0000#groups/OG005
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-hernexeos-15f55fd1
- nct id
- NCT04579380
- outcome key
- om-0000
- arm key
- OG006
- arm label
- Tucatinib+Trastuzumab (Cohort 7)
- regimen
- Participants with non-squamous NSCLC with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04579380-om-0000#groups/OG006
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-hernexeos-15f55fd1
- nct id
- NCT04579380
- outcome key
- om-0000
- arm key
- OG007
- arm label
- Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8)
- regimen
- Participants with breast cancer with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants with hormone-receptor positive breast cancer also received fulvestrant 500 mg IM once every 4 weeks starting from Day 1 of Cycle 1, and on Day 15 of Cycle 1. Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
- analyzed count
- 31
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04579380-om-0000#groups/OG007
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-hernexeos-15f55fd1
- nct id
- NCT04579380
- outcome key
- om-0000
- arm key
- OG008
- arm label
- Tucatinib+Trastuzumab (Cohort 9)
- regimen
- Participants with all solid tumor cancers (except breast and non-squamous NSCLC) with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
- analyzed count
- 29
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04579380-om-0000#groups/OG008
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-hernexeos-15f55fd1
- nct id
- NCT04579380
- harm key
- EG000
- source section id
- NCT04579380-ae
- event group key
- EG000
- event group label
- Tucatinib+Trastuzumab (Cohort 1)
- serious affected
- 5
- serious at risk
- 11
- other affected
- 10
- other at risk
- 11
- frequency threshold
- 5
- collection period
- From first dose of the study treatment (Day 1) maximum up to 30 days after the last dose of study treatment death date, or data cut-off date, whichever was earlier (maximum up to 28.8 months)
- event definition
- Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. Safety analysis set: all participants who received any amount of study drug. All-cause mortality: No. of deaths were reported from Day 1 of study through End of Study for all participants.
- 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-hernexeos-15f55fd1
- nct id
- NCT04579380
- harm key
- EG001
- source section id
- NCT04579380-ae
- event group key
- EG001
- event group label
- Tucatinib+Trastuzumab (Cohort 2)
- serious affected
- 11
- serious at risk
- 31
- other affected
- 30
- other at risk
- 31
- frequency threshold
- 5
- collection period
- From first dose of the study treatment (Day 1) maximum up to 30 days after the last dose of study treatment death date, or data cut-off date, whichever was earlier (maximum up to 28.8 months)
- event definition
- Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. Safety analysis set: all participants who received any amount of study drug. All-cause mortality: No. of deaths were reported from Day 1 of study through End of Study for all participants.
- 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-hernexeos-15f55fd1
- nct id
- NCT04579380
- harm key
- EG002
- source section id
- NCT04579380-ae
- event group key
- EG002
- event group label
- Tucatinib+Trastuzumab (Cohort 3)
- serious affected
- 13
- serious at risk
- 30
- other affected
- 29
- other at risk
- 30
- frequency threshold
- 5
- collection period
- From first dose of the study treatment (Day 1) maximum up to 30 days after the last dose of study treatment death date, or data cut-off date, whichever was earlier (maximum up to 28.8 months)
- event definition
- Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. Safety analysis set: all participants who received any amount of study drug. All-cause mortality: No. of deaths were reported from Day 1 of study through End of Study for all participants.
- 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-hernexeos-15f55fd1
- nct id
- NCT04579380
- harm key
- EG003
- source section id
- NCT04579380-ae
- event group key
- EG003
- event group label
- Tucatinib+Trastuzumab (Cohort 4)
- serious affected
- 9
- serious at risk
- 25
- other affected
- 23
- other at risk
- 25
- frequency threshold
- 5
- collection period
- From first dose of the study treatment (Day 1) maximum up to 30 days after the last dose of study treatment death date, or data cut-off date, whichever was earlier (maximum up to 28.8 months)
- event definition
- Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. Safety analysis set: all participants who received any amount of study drug. All-cause mortality: No. of deaths were reported from Day 1 of study through End of Study for all participants.
- 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-hernexeos-15f55fd1
- nct id
- NCT04579380
- harm key
- EG004
- source section id
- NCT04579380-ae
- event group key
- EG004
- event group label
- Tucatinib+Trastuzumab (Cohort 5)
- serious affected
- 2
- serious at risk
- 12
- other affected
- 12
- other at risk
- 12
- frequency threshold
- 5
- collection period
- From first dose of the study treatment (Day 1) maximum up to 30 days after the last dose of study treatment death date, or data cut-off date, whichever was earlier (maximum up to 28.8 months)
- event definition
- Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. Safety analysis set: all participants who received any amount of study drug. All-cause mortality: No. of deaths were reported from Day 1 of study through End of Study for all participants.
- 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-hernexeos-15f55fd1
- nct id
- NCT04579380
- harm key
- EG005
- source section id
- NCT04579380-ae
- event group key
- EG005
- event group label
- Tucatinib+Trastuzumab (Cohort 6)
- serious affected
- 9
- serious at risk
- 31
- other affected
- 29
- other at risk
- 31
- frequency threshold
- 5
- collection period
- From first dose of the study treatment (Day 1) maximum up to 30 days after the last dose of study treatment death date, or data cut-off date, whichever was earlier (maximum up to 28.8 months)
- event definition
- Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. Safety analysis set: all participants who received any amount of study drug. All-cause mortality: No. of deaths were reported from Day 1 of study through End of Study for all participants.
- 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-hernexeos-15f55fd1
- nct id
- NCT04579380
- harm key
- EG006
- source section id
- NCT04579380-ae
- event group key
- EG006
- event group label
- Tucatinib+Trastuzumab (Cohort 7)
- serious affected
- 7
- serious at risk
- 13
- other affected
- 13
- other at risk
- 13
- frequency threshold
- 5
- collection period
- From first dose of the study treatment (Day 1) maximum up to 30 days after the last dose of study treatment death date, or data cut-off date, whichever was earlier (maximum up to 28.8 months)
- event definition
- Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. Safety analysis set: all participants who received any amount of study drug. All-cause mortality: No. of deaths were reported from Day 1 of study through End of Study for all participants.
- 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-hernexeos-15f55fd1
- nct id
- NCT04579380
- harm key
- EG007
- source section id
- NCT04579380-ae
- event group key
- EG007
- event group label
- Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8)
- serious affected
- 8
- serious at risk
- 31
- other affected
- 31
- other at risk
- 31
- frequency threshold
- 5
- collection period
- From first dose of the study treatment (Day 1) maximum up to 30 days after the last dose of study treatment death date, or data cut-off date, whichever was earlier (maximum up to 28.8 months)
- event definition
- Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. Safety analysis set: all participants who received any amount of study drug. All-cause mortality: No. of deaths were reported from Day 1 of study through End of Study for all participants.
- 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-hernexeos-15f55fd1
- nct id
- NCT04579380
- harm key
- EG008
- source section id
- NCT04579380-ae
- event group key
- EG008
- event group label
- Tucatinib+Trastuzumab (Cohort 9)
- serious affected
- 14
- serious at risk
- 33
- other affected
- 30
- other at risk
- 33
- frequency threshold
- 5
- collection period
- From first dose of the study treatment (Day 1) maximum up to 30 days after the last dose of study treatment death date, or data cut-off date, whichever was earlier (maximum up to 28.8 months)
- event definition
- Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. Safety analysis set: all participants who received any amount of study drug. All-cause mortality: No. of deaths were reported from Day 1 of study through End of Study for all participants.
- 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