NCT06385483 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Patients receive afatinib 40 mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients may also undergo ECHO or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study.
- id
- FG000
- title
- Treatment (Afatinib)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Never start protocol therapy
- reasons
- group Id
- FG000
- num Subjects
- 15
- type
- Disease progression
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 19
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 17
- type
- Started Protocol Therapy
- achievements
- group Id
- FG000
- num Subjects
- 17
- comment
- Primary efficacy analysis set
- type
- Eligible, Treated and Mutation Status Confirmed
- achievements
- group Id
- FG000
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 19
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- EGFR variants allowing entry into subprotocol A included classic activating deletion 19 and L858R EGFR mutations, EGFR G719A, G719C, G719D, G719S, L861Q, and S768I. The mutation status was determined by a CLIA-approved assay performed in an NCI-MATCH approved laboratory, these cases had to be confirmed to be used in primary analysis.
- recruitment Details
- Subprotocol A was activated on August 12, 2015. Nineteen patients were enrolled between February 2018 and January 2020. All patients were enrolled though the outside laboratory and had their samples centrally confirmed.
Complete source fields
- groups
- description
- Patients receive afatinib 40 mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients may also undergo ECHO or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study.
- id
- FG000
- title
- Treatment (Afatinib)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Never start protocol therapy
- reasons
- group Id
- FG000
- num Subjects
- 15
- type
- Disease progression
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 19
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 17
- type
- Started Protocol Therapy
- achievements
- group Id
- FG000
- num Subjects
- 17
- comment
- Primary efficacy analysis set
- type
- Eligible, Treated and Mutation Status Confirmed
- achievements
- group Id
- FG000
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 19
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- EGFR variants allowing entry into subprotocol A included classic activating deletion 19 and L858R EGFR mutations, EGFR G719A, G719C, G719D, G719S, L861Q, and S768I. The mutation status was determined by a CLIA-approved assay performed in an NCI-MATCH approved laboratory, these cases had to be confirmed to be used in primary analysis.
- recruitment Details
- Subprotocol A was activated on August 12, 2015. Nineteen patients were enrolled between February 2018 and January 2020. All patients were enrolled though the outside laboratory and had their samples centrally confirmed.
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