TriangleNCT02486718 · STUDY IN CONTEXT
Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]
Draft scope assessment: unclear. Attached because the study's own record names PD-L1. 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
DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.
DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. DFS was analyzed in participants with disease stage II-IIIA. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.
DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. DFS was analyzed in PD-L1 ≥1% subpopulation within the Stage II-IIIA population. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.
OS was defined as the time from randomization to death from any cause.
DFS rate was defined as percentage of participants who were disease-free at Year 3. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.
DFS rate was defined as percentage of participants who were disease-free at Year 3. DFS rate was analyzed in participants with disease stage II-IIIA. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.
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-tecentriq-hybreza-cba0c696
- nct id
- NCT02486718
- trial label
- Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]
- applicability
- unclear
- applicability note
- Attached because the study's own record names PD-L1. 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
- 3
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-tecentriq-hybreza-cba0c696
- nct id
- NCT02486718
- outcome key
- om-0000
- source section id
- NCT02486718-om-0000
- source outcome index
- 0
- endpoint
- Disease-Free Survival (DFS) in Intent-to-treat (ITT) Population
- endpoint definition
- DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.
- time origin
- Up to 95 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Randomized ITT population was defined as all randomized participants with resected Stage IB \[tumors ≥ 4 centimetres (cm)\]-IIIA NSCLC whether or not the participant received the assigned treatment.
- 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-tecentriq-hybreza-cba0c696
- nct id
- NCT02486718
- outcome key
- om-0001
- source section id
- NCT02486718-om-0001
- source outcome index
- 1
- endpoint
- DFS in All Randomized Stage II-IIIA Population
- endpoint definition
- DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. DFS was analyzed in participants with disease stage II-IIIA. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.
- time origin
- Up to 95 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Stage II-IIIA population was defined as all randomized participants with extent of disease as either Stage II or Stage IIIA, and is a subset of the ITT population. Randomized ITT population was defined as all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether or not the participant received the assigned treatment.
- 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-tecentriq-hybreza-cba0c696
- nct id
- NCT02486718
- outcome key
- om-0002
- source section id
- NCT02486718-om-0002
- source outcome index
- 2
- endpoint
- DFS in the Programmed Death-ligand 1 (PD-L1) SP263 ≥ 1% Tumor Cell (TC) Subpopulation Within the Stage II-IIIA Population
- endpoint definition
- DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. DFS was analyzed in PD-L1 ≥1% subpopulation within the Stage II-IIIA population. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.
- time origin
- Up to 95 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- PD-L1 subpopulation, defined as ≥1% TC expression by the SP263 immunohistochemistry (IHC) assay, included Stage II-IIIA population with valid PD-L1 SP263 measurement at baseline. Stage II-IIIA population included all randomized participants with extent of disease as either Stage II or Stage III, \& is a subset of ITT population. Randomized ITT population included all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether the participant received the assigned treatment.
- 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-tecentriq-hybreza-cba0c696
- nct id
- NCT02486718
- outcome key
- om-0003
- source section id
- NCT02486718-om-0003
- source outcome index
- 3
- endpoint
- Overall Survival (OS) in the ITT Population
- endpoint definition
- OS was defined as the time from randomization to death from any cause.
- time origin
- Baseline up to death from any cause (up to approximately 126 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-tecentriq-hybreza-cba0c696
- nct id
- NCT02486718
- outcome key
- om-0004
- source section id
- NCT02486718-om-0004
- source outcome index
- 4
- endpoint
- Disease-free Rate at Year 3 in ITT Population
- endpoint definition
- DFS rate was defined as percentage of participants who were disease-free at Year 3. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.
- time origin
- Year 3
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Randomized ITT population was defined as all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether or not the participant received the assigned treatment.
- 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-tecentriq-hybreza-cba0c696
- nct id
- NCT02486718
- outcome key
- om-0005
- source section id
- NCT02486718-om-0005
- source outcome index
- 5
- endpoint
- Disease-free Rate at Year 3 in All Randomized Stage II-IIIA Population
- endpoint definition
- DFS rate was defined as percentage of participants who were disease-free at Year 3. DFS rate was analyzed in participants with disease stage II-IIIA. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.
- time origin
- Year 3
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Stage II-IIIA population was defined as all randomized participants with extent of disease as either Stage II or Stage III, and is a subset of the ITT population. Randomized ITT population was defined as all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether or not the participant received the assigned 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-tecentriq-hybreza-cba0c696
- nct id
- NCT02486718
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Atezolizumab
- regimen
- Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
- analyzed count
- 507
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02486718-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-tecentriq-hybreza-cba0c696
- nct id
- NCT02486718
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Best Supportive Care (BSC)
- regimen
- Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.
- analyzed count
- 498
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02486718-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-tecentriq-hybreza-cba0c696
- nct id
- NCT02486718
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Atezolizumab
- regimen
- Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
- analyzed count
- 442
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02486718-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-tecentriq-hybreza-cba0c696
- nct id
- NCT02486718
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Best Supportive Care (BSC)
- regimen
- Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.
- analyzed count
- 440
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02486718-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-tecentriq-hybreza-cba0c696
- nct id
- NCT02486718
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Atezolizumab
- regimen
- Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
- analyzed count
- 248
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02486718-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-tecentriq-hybreza-cba0c696
- nct id
- NCT02486718
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Best Supportive Care (BSC)
- regimen
- Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.
- analyzed count
- 228
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02486718-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-tecentriq-hybreza-cba0c696
- nct id
- NCT02486718
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Atezolizumab
- regimen
- Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
- analyzed count
- 507
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02486718-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-tecentriq-hybreza-cba0c696
- nct id
- NCT02486718
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Best Supportive Care (BSC)
- regimen
- Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.
- analyzed count
- 498
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02486718-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-tecentriq-hybreza-cba0c696
- nct id
- NCT02486718
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Atezolizumab
- regimen
- Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
- analyzed count
- 442
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02486718-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-tecentriq-hybreza-cba0c696
- nct id
- NCT02486718
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Best Supportive Care (BSC)
- regimen
- Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.
- analyzed count
- 440
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02486718-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-tecentriq-hybreza-cba0c696
- nct id
- NCT02486718
- harm key
- EG000
- source section id
- NCT02486718-ae
- event group key
- EG000
- event group label
- Enrollment Phase
- serious affected
- 259
- serious at risk
- 1269
- other affected
- 1153
- other at risk
- 1269
- frequency threshold
- 5
- collection period
- Up to 95 months
- event definition
- Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
- 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-tecentriq-hybreza-cba0c696
- nct id
- NCT02486718
- harm key
- EG001
- source section id
- NCT02486718-ae
- event group key
- EG001
- event group label
- Best Supportive Care (BSC)
- serious affected
- 42
- serious at risk
- 495
- other affected
- 227
- other at risk
- 495
- frequency threshold
- 5
- collection period
- Up to 95 months
- event definition
- Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
- 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-tecentriq-hybreza-cba0c696
- nct id
- NCT02486718
- harm key
- EG002
- source section id
- NCT02486718-ae
- event group key
- EG002
- event group label
- Atezolizumab
- serious affected
- 88
- serious at risk
- 495
- other affected
- 358
- other at risk
- 495
- frequency threshold
- 5
- collection period
- Up to 95 months
- event definition
- Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
- 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