TriangleNCT02094261 · STUDY IN CONTEXT
Phase II AZD9291 Open Label Study in NSCLC After Previous EGFR TKI Therapy in EGFR and T790M Mutation Positive Tumours
Draft scope assessment: unclear. Attached because the study's own record 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
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (according to independent review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR was defined as the time from the date of first documented response (CR or PR that was subsequently confirmed) until the date of documented progression (PD) or death in the absence of disease progression (by investigator assessment).
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): \>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. DCR is the percentage of patients with best response of CR, PR or SD (according to independent review), prior to progression (PD) or further anti-cancer therapy.
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): \>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of first dose until the date of PD (by independent review) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from AZD9291 therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment.
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-pemetrexed-dipotassium-5413371b
- nct id
- NCT02094261
- trial label
- Phase II AZD9291 Open Label Study in NSCLC After Previous EGFR TKI Therapy in EGFR and T790M Mutation Positive Tumours
- applicability
- unclear
- applicability note
- Attached because the study's own record 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
- 4
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-pemetrexed-dipotassium-5413371b
- nct id
- NCT02094261
- outcome key
- om-0000
- source section id
- NCT02094261-om-0000
- source outcome index
- 0
- endpoint
- Objective Response Rate (ORR)
- endpoint definition
- Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (according to independent review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.
- time origin
- RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months (at the time of analysis)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients who received at least 1 dose of study treatment and had measurable disease at baseline according to the independent review of baseline imaging data.
- 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-pemetrexed-dipotassium-5413371b
- nct id
- NCT02094261
- outcome key
- om-0001
- source section id
- NCT02094261-om-0001
- source outcome index
- 1
- endpoint
- Duration of Response (DoR)
- endpoint definition
- Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR was defined as the time from the date of first documented response (CR or PR that was subsequently confirmed) until the date of documented progression (PD) or death in the absence of disease progression (by investigator assessment).
- time origin
- RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months (at the time of analysis)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients who received at least 1 dose of study treatment, had measurable disease at baseline according to the independent review of baseline imaging data and had confirmed response.
- 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-pemetrexed-dipotassium-5413371b
- nct id
- NCT02094261
- outcome key
- om-0002
- source section id
- NCT02094261-om-0002
- source outcome index
- 2
- endpoint
- Disease Control Rate (DCR)
- endpoint definition
- Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): \>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. DCR is the percentage of patients with best response of CR, PR or SD (according to independent review), prior to progression (PD) or further anti-cancer therapy.
- time origin
- RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months (at the time of analysis)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients who received at least 1 dose of study treatment and had measurable disease at baseline according to the independent review of baseline imaging data.
- 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-pemetrexed-dipotassium-5413371b
- nct id
- NCT02094261
- outcome key
- om-0003
- source section id
- NCT02094261-om-0003
- source outcome index
- 3
- endpoint
- Progression-Free Survival (PFS)
- endpoint definition
- Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): \>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of first dose until the date of PD (by independent review) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from AZD9291 therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment.
- time origin
- RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months (at the time of analysis)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients who received at least 1 dose of study treatment.
- 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-pemetrexed-dipotassium-5413371b
- nct id
- NCT02094261
- outcome key
- om-0000
- arm key
- OG000
- arm label
- AZD9291 80mg
- regimen
- Daily single dose of AZD9291 80mg
- analyzed count
- 199
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02094261-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-pemetrexed-dipotassium-5413371b
- nct id
- NCT02094261
- outcome key
- om-0001
- arm key
- OG000
- arm label
- AZD9291 80mg
- regimen
- Daily single dose of AZD9291 80mg
- analyzed count
- 141
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02094261-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-pemetrexed-dipotassium-5413371b
- nct id
- NCT02094261
- outcome key
- om-0002
- arm key
- OG000
- arm label
- AZD9291 80mg
- regimen
- Daily single dose of AZD9291 80mg
- analyzed count
- 199
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02094261-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-pemetrexed-dipotassium-5413371b
- nct id
- NCT02094261
- outcome key
- om-0003
- arm key
- OG000
- arm label
- AZD9291 80mg
- regimen
- Daily single dose of AZD9291 80mg
- analyzed count
- 210
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02094261-om-0003#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-pemetrexed-dipotassium-5413371b
- nct id
- NCT02094261
- harm key
- EG000
- source section id
- NCT02094261-ae
- event group key
- EG000
- event group label
- AZD9291 80mg
- serious affected
- 42
- serious at risk
- 210
- other affected
- 193
- other at risk
- 210
- frequency threshold
- 5
- collection period
- AEs from start of study drug until 28 days post treatment discontinuation, up to approximately 11 months (at time of analysis).
- event definition
- Systematic assessment due to regular investigator assessment at study visits.
- 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