NCT06303167 · 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 osimertinib (AZD9291) 80 mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo radiologic evaluation throughout the trial, ECHO or MUGA during screening, and biopsy and collection of blood samples on trial and at end of treatment.
- id
- FG000
- title
- Treatment (Osimertinib)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Ineligible
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Never start protocol therapy
- reasons
- group Id
- FG000
- num Subjects
- 16
- 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
- 16
- type
- Eligible and Treated
- achievements
- group Id
- FG000
- num Subjects
- 13
- 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
- Patients with an EGFR T790M mutation in any histology except lung cancer and patients with a rare activating mutation (EGFR G719A, G719C, G719D, G719S, L861Q, S786I, or an exon 19 in frame insertion mutations) in any histology were offered participation in this subprotocol. The mutation status was determined by a CLIA-approved assay performed in an NCI-MATCH approved laboratory for 16 patients in this arm, these cases had to be confirmed to be used in primary analysis.
- recruitment Details
- Subprotocol E was activated on August 12, 2015. Nineteen patients were enrolled between January 2016 and November 2021. Three patients were enrolled on the basis of the results from the NCI-MATCH assay and 16 on the basis of the outside assay results.
Complete source fields
- groups
- description
- Patients receive osimertinib (AZD9291) 80 mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo radiologic evaluation throughout the trial, ECHO or MUGA during screening, and biopsy and collection of blood samples on trial and at end of treatment.
- id
- FG000
- title
- Treatment (Osimertinib)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Ineligible
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Never start protocol therapy
- reasons
- group Id
- FG000
- num Subjects
- 16
- 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
- 16
- type
- Eligible and Treated
- achievements
- group Id
- FG000
- num Subjects
- 13
- 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
- Patients with an EGFR T790M mutation in any histology except lung cancer and patients with a rare activating mutation (EGFR G719A, G719C, G719D, G719S, L861Q, S786I, or an exon 19 in frame insertion mutations) in any histology were offered participation in this subprotocol. The mutation status was determined by a CLIA-approved assay performed in an NCI-MATCH approved laboratory for 16 patients in this arm, these cases had to be confirmed to be used in primary analysis.
- recruitment Details
- Subprotocol E was activated on August 12, 2015. Nineteen patients were enrolled between January 2016 and November 2021. Three patients were enrolled on the basis of the results from the NCI-MATCH assay and 16 on the basis of the outside assay results.
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Preserved source evidence · Not medical advice
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