A Study of Intermittent, High-dose Afatinib to Determine the Maximal Tolerated Dose and Assess Activity of This Dose Against Non-small Cell Lung Cancer With T790M Mutations

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 by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

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

Percentage of participants with Dose Limiting Toxicities (DLTs), based on investigator assessment, for determination of Maximum Tolerated Dose (MTD). MTD was defined as the dose in which less than 2 of up to 6 patients developed a DLT.

Treated set including patients eligible for MTD determination

→

primary · POSTED

Maximum Tolerated Dose (MTD) was defined as the dose in which less than 2 of up to 6 patients developed a Dose Limiting Toxicity (DLT).

Treated set including patients eligible for MTD determination

→

secondary · POSTED

Objective response rate for patients with Epidermal Growth Factor Receptor (EGFR) T790M mutations. Objective response was defined as Complete Response (CR): Disappearance of all target lesion or Partial Response and (PR): \>=30% decrease in the sum of the longest diameter of target lesions, according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. This endpoint was originally planned to be analysed in part B of the study, however as no participants were treated in part B the analysis was performed on the part A participants.

Treated set including participants with EGFR T790M positive mutations

→

secondary · POSTED

Maximum measured concentration (Cmax) of afatinib as determined on day 3 of course 1 for patients in Part A

Pharmacokinetic set which included all patients treated in part A who were documented to have taken at least one dose of afatinib and who had in addition at least one valid afatinib concentration available.

→

secondary · POSTED

Determination of dosage for expansion cohort in Part B. Dosage was the MTD or less depending on tolerability.

Treated set including patients eligible for MTD determination

→

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

FACT · Objective Response Rate for Patients With EGFR T790M Mutations

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id: NCT01647711
qol key: qol-0001
source section id: NCT01647711-om-0001
source outcome index: 1
instrument: FACT
instrument basis: matched 'factor' in the study's own wording
scale title: Objective Response Rate for Patients With EGFR T790M Mutations
measure definition: Objective response rate for patients with Epidermal Growth Factor Receptor (EGFR) T790M mutations. Objective response was defined as Complete Response (CR): Disappearance of all target lesion or Partial Response and (PR): \>=30% decrease in the sum of the longest diameter of target lesions, according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. This endpoint was originally planned to be analysed in part B of the study, however as no participants were treated in part B the analysis was performed on the part A participants.
time frame: From first drug administration until last drug administration, up to 420 days
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: Treated set including participants with EGFR T790M positive mutations
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

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: NCT01647711
trial label: A Study of Intermittent, High-dose Afatinib to Determine the Maximal Tolerated Dose and Assess Activity of This Dose Against Non-small Cell Lung Cancer With T790M Mutations
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: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 5
harms Count: 6
qol Count: 1

outcomes

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT01647711
outcome key
om-0000
source section id
NCT01647711-om-0000
source outcome index
0
endpoint
Percentage of Participants With Dose Limiting Toxicities
endpoint definition
Percentage of participants with Dose Limiting Toxicities (DLTs), based on investigator assessment, for determination of Maximum Tolerated Dose (MTD). MTD was defined as the dose in which less than 2 of up to 6 patients developed a DLT.
time origin
28 days
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Treated set including patients eligible for MTD determination
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
NCT01647711
outcome key
om-0004
source section id
NCT01647711-om-0004
source outcome index
4
endpoint
Maximum Tolerated Dose
endpoint definition
Maximum Tolerated Dose (MTD) was defined as the dose in which less than 2 of up to 6 patients developed a Dose Limiting Toxicity (DLT).
time origin
28 days
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Treated set including patients eligible for MTD determination
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
NCT01647711
outcome key
om-0001
source section id
NCT01647711-om-0001
source outcome index
1
endpoint
Objective Response Rate for Patients With EGFR T790M Mutations
endpoint definition
Objective response rate for patients with Epidermal Growth Factor Receptor (EGFR) T790M mutations. Objective response was defined as Complete Response (CR): Disappearance of all target lesion or Partial Response and (PR): \>=30% decrease in the sum of the longest diameter of target lesions, according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. This endpoint was originally planned to be analysed in part B of the study, however as no participants were treated in part B the analysis was performed on the part A participants.
time origin
From first drug administration until last drug administration, up to 420 days
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Treated set including participants with EGFR T790M positive mutations
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
NCT01647711
outcome key
om-0002
source section id
NCT01647711-om-0002
source outcome index
2
endpoint
Cmax of Afatinib on Day 3 of Course 1
endpoint definition
Maximum measured concentration (Cmax) of afatinib as determined on day 3 of course 1 for patients in Part A
time origin
47 hours (h) 55 minutes (min), 49h, 50h, 51h, 52h, 53h, 54h, 55h after first dose administration (on day 3 of course 1)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Pharmacokinetic set which included all patients treated in part A who were documented to have taken at least one dose of afatinib and who had in addition at least one valid afatinib concentration available.
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
NCT01647711
outcome key
om-0003
source section id
NCT01647711-om-0003
source outcome index
3
endpoint
Determination of Dosage for Expansion Cohort in Part B
endpoint definition
Determination of dosage for expansion cohort in Part B. Dosage was the MTD or less depending on tolerability.
time origin
28 days
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Treated set including patients eligible for MTD determination
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
NCT01647711
outcome key
om-0000
arm key
OG000
arm label
Afatinib 90mg
regimen
Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01647711-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT01647711
outcome key
om-0000
arm key
OG001
arm label
Afatinib 120mg
regimen
Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01647711-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT01647711
outcome key
om-0000
arm key
OG002
arm label
Afatinib 150mg
regimen
Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01647711-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT01647711
outcome key
om-0000
arm key
OG003
arm label
Afatinib 160mg
regimen
Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
analyzed count
9
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01647711-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT01647711
outcome key
om-0000
arm key
OG004
arm label
Afatinib 200mg
regimen
Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01647711-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT01647711
outcome key
om-0001
arm key
OG000
arm label
Afatinib 90mg
regimen
Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01647711-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT01647711
outcome key
om-0001
arm key
OG001
arm label
Afatinib 120mg
regimen
Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01647711-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT01647711
outcome key
om-0001
arm key
OG002
arm label
Afatinib 150mg
regimen
Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01647711-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT01647711
outcome key
om-0001
arm key
OG003
arm label
Afatinib 160mg
regimen
Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01647711-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT01647711
outcome key
om-0001
arm key
OG004
arm label
Afatinib 200mg
regimen
Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01647711-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT01647711
outcome key
om-0002
arm key
OG000
arm label
Afatinib 90mg
regimen
Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01647711-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT01647711
outcome key
om-0002
arm key
OG001
arm label
Afatinib 120mg
regimen
Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01647711-om-0002#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT01647711
harm key
EG000
source section id
NCT01647711-ae
event group key
EG000
event group label
Afatinib 90mg
serious affected
1
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
From first treatment administration until 28 days after the last administration, up to 448 days
event definition
Source null
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
NCT01647711
harm key
EG001
source section id
NCT01647711-ae
event group key
EG001
event group label
Afatinib 120mg
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
From first treatment administration until 28 days after the last administration, up to 448 days
event definition
Source null
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
NCT01647711
harm key
EG002
source section id
NCT01647711-ae
event group key
EG002
event group label
Afatinib 150mg
serious affected
7
serious at risk
9
other affected
9
other at risk
9
frequency threshold
5
collection period
From first treatment administration until 28 days after the last administration, up to 448 days
event definition
Source null
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
NCT01647711
harm key
EG003
source section id
NCT01647711-ae
event group key
EG003
event group label
Afatinib 160mg
serious affected
4
serious at risk
11
other affected
11
other at risk
11
frequency threshold
5
collection period
From first treatment administration until 28 days after the last administration, up to 448 days
event definition
Source null
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
NCT01647711
harm key
EG004
source section id
NCT01647711-ae
event group key
EG004
event group label
Afatinib 200mg
serious affected
1
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
From first treatment administration until 28 days after the last administration, up to 448 days
event definition
Source null
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
NCT01647711
harm key
EG005
source section id
NCT01647711-ae
event group key
EG005
event group label
All Participants
serious affected
14
serious at risk
35
other affected
35
other at risk
35
frequency threshold
5
collection period
From first treatment administration until 28 days after the last administration, up to 448 days
event definition
Source null
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

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-rybrevant-faspro-964accb6
nct id
NCT01647711
qol key
qol-0001
source section id
NCT01647711-om-0001
source outcome index
1
instrument
FACT
instrument basis
matched 'factor' in the study's own wording
scale title
Objective Response Rate for Patients With EGFR T790M Mutations
measure definition
Objective response rate for patients with Epidermal Growth Factor Receptor (EGFR) T790M mutations. Objective response was defined as Complete Response (CR): Disappearance of all target lesion or Partial Response and (PR): \>=30% decrease in the sum of the longest diameter of target lesions, according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. This endpoint was originally planned to be analysed in part B of the study, however as no participants were treated in part B the analysis was performed on the part A participants.
time frame
From first drug administration until last drug administration, up to 420 days
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Treated set including participants with EGFR T790M positive mutations
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

setting source links

Preserved source evidence · Not medical advice