Trial · NCT02031458
A Study of Atezolizumab in Participants With Programmed Death - Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
NCT02031458, Phase 2, Completed, Hoffmann-La Roche; results first posted 2017-03-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Atezolizumab in Participants With Programmed Death - Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer. Trials, record NCT02031458. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02031458
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Atezolizumab in Participants With Programmed Death - Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- NCT number
- NCT02031458
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 667 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Atezolizumab
- First posted
- 2014-01-09
- Last updated
- 2020-01-06
- Other registries' IDs
- eudract:2013-003330-32
- Results first posted
- 2017-03-23
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Objective Response (ORR) Per Response Evaluation Criteria In Solid Tumors (RECIST) Version (v) 1.1 as Assessed by Independent Review Facility (IRF) | Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) | ORR was the percentage of participants whose confirmed best overall response was either a Partial Response (PR) or a Complete Response (CR) based upon the IRF assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm); PR:greater than (\>) or equal to (=) 30 percent (%) decrease from baseline in sum of diameters of target lesions, non-progressive disease (PD) non-target lesions and no new lesions. Results were reported by line of therapy and programmed death-ligand 1 (PD-L1) Expression Subgroup (tumor cell \[TC\]3 \[TC3\] or tumor-infiltrating immune cell \[IC\] 3 \[IC3\], TC3 or IC2/3, TC2/3 or IC2/3). |
| Secondary | Percentage of Participants Achieving Objective Response Per RECIST v1.1 as Assessed by the Investigator (INV) | Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) | ORR was the percentage of participants whose confirmed best overall response was either a PR or a CR based upon the Investigator assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10mm; PR: \> or = 30 % decrease from baseline in sum of diameters of target lesions, non-PD non-target lesions and no new lesions. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3). |
| Secondary | Percentage of Participants Achieving Objective Response Per Modified RECIST as Assessed by the INV | Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) | ORR was the percentage of participants whose confirmed best overall response was either a PR or a CR based upon the Investigator assessment per modified RECIST. CR: disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10mm; PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3). |
| Secondary | Duration of Response (DOR) Assessed by IRF Per RECIST v1.1 | Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) | DOR is interval between date of first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and the first date that PD or death is documented, whichever occurs first as measured by RECIST v1.1. CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10mm; PR: \> or = 30 % decrease from baseline in sum of diameters of target lesions, non-PD non-target lesions and no new lesions; PD: one or more of the following: at least 20% increase from nadir in sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions. DOR was assessed by Kaplan-Meier estimates. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3). |
| Secondary | DOR as Assessed by INV Per RECIST v1.1 | Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) | DOR is interval between date of the first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and first date that PD or death is documented, whichever occurs first as measured by RECIST v1.1. CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10mm; PR: \> or = 30 % decrease from baseline in sum of diameters of target lesions, non-PD non-target lesions and no new lesions; PD: one or more of the following: at least 20% increase from nadir in sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions. DOR was assessed by Kaplan-Meier estimates. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3). |
| Secondary | DOR as Assessed by INV Per Modified RECIST | Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) | DOR is the interval between the date of the first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and the first date that PD or death is documented, whichever occurs first as measured by modified RECIST. CR: disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10mm; PR: at least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR; PD: one or more of the following: at least 20% increase from nadir in the sum of diameters of existing and/or new target lesions (with an absolute increase of at least 5mm). DOR was assessed by Kaplan-Meier estimates. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3). |
| Secondary | Progression Free Survival (PFS) as Assessed by IRF Per RECIST v1.1 | Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) | PFS is the interval between the first dose of atezolizumab and date of disease progression or death due to any cause, whichever occurred first as measured by RECIST v1.1. PD is defined as one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions. PFS was assessed by Kaplan-Meier estimates. |
| Secondary | PFS as Assessed by INV Per RECIST v1.1 | Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) | PFS is the interval between the first dose of atezolizumab and date of disease progression or death due to any cause, whichever occurred first as measured by RECIST v1.1. PD: one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions. PFS was assessed by Kaplan-Meier estimates. |
| Secondary | PFS as Assessed by INV Per Modified RECIST | Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) | PFS is the interval between the first dose of atezolizumab and date of disease progression or death due to any cause, whichever occurred first as measured by modified RECIST. PD: at least 20% increase from nadir in the sum of diameters of new and/or existing target lesions (with an absolute increase of at least 5mm). PFS was assessed by Kaplan-Meier estimates. |
| Secondary | Overall Survival : Percentage of Participants Without Event (Death) | Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Objective Response (ORR) Per Response Evaluation Criteria In Solid Tumors (RECIST) Version (v) 1.1 as Assessed by Independent Review Facility (IRF) | Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) | Efficacy evaluable population; Number (n) equals (=) number of participants analyzed within the specified group. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Objective Response Per RECIST v1.1 as Assessed by the Investigator (INV) | Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) | Efficacy evaluable population; n = number of participants analyzed within the specified group. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Objective Response Per Modified RECIST as Assessed by the INV | Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) | Efficacy evaluable population; n= number of participants analyzed within the specified group. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) Assessed by IRF Per RECIST v1.1 | Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) | Efficacy evaluable population; n = number of participants analyzed within the specified group. Number of participants analyzed = overall number of participants who were evaluable for this outcome. | months | MEDIAN |
| SECONDARY | DOR as Assessed by INV Per RECIST v1.1 | Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) | Efficacy evaluable population; n = number of participants analyzed within the specified group. Number of participants analyzed = overall number of participants who were evaluable for this outcome. | months | MEDIAN |
| SECONDARY | DOR as Assessed by INV Per Modified RECIST | Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) | Efficacy evaluable population; n = number of participants analyzed within the specified group. Number of participants analyzed = overall number of participants who were evaluable for this outcome | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) as Assessed by IRF Per RECIST v1.1 | Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) | Efficacy evaluable population; n = number of participants analyzed within the specified group. | months | MEDIAN |
| SECONDARY | PFS as Assessed by INV Per RECIST v1.1 | Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) | Efficacy evaluable population; n = number of participants analyzed within the specified group. | months | MEDIAN |
| SECONDARY | PFS as Assessed by INV Per Modified RECIST | Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) | Efficacy evaluable population; n = number of participants analyzed within the specified group. | months | MEDIAN |
| SECONDARY | Overall Survival : Percentage of Participants Without Event (Death) | Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) | Efficacy evaluable population; n = number of participants analyzed within the specified group. | percentage of participants | NUMBER |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group246
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Objective Response (ORR) Per Response Evaluation Criteria In Solid Tumors (RECIST) Version (v) 1.1 as Assessed by Independent Review Facility (IRF) | Cohort 1: First Line Atezolizumab | TC3 or IC3 Responders | 26.2 | 95% Confidence Interval 16.0 to 38.5 | percentage of participants |
| Percentage of Participants Achieving Objective Response (ORR) Per Response Evaluation Criteria In Solid Tumors (RECIST) Version (v) 1.1 as Assessed by Independent Review Facility (IRF) | Cohort 2: Second Line Atezolizumab | TC3 or IC3 Responders | 23.8 | 95% Confidence Interval 16.5 to 32.3 | percentage of participants |
| Percentage of Participants Achieving Objective Response (ORR) Per Response Evaluation Criteria In Solid Tumors (RECIST) Version (v) 1.1 as Assessed by Independent Review Facility (IRF) | Cohort 3: Third Line and Beyond Atezolizumab | TC3 or IC3 Responders | 27.0 | 95% Confidence Interval 19.1 to 36.0 | percentage of participants |
| Percentage of Participants Achieving Objective Response (ORR) Per Response Evaluation Criteria In Solid Tumors (RECIST) Version (v) 1.1 as Assessed by Independent Review Facility (IRF) | Cohorts 2 + 3 | TC3 or IC3 Responders | 25.35 | 95% Confidence Interval 19.9 to 31.4 | percentage of participants |
| Percentage of Participants Achieving Objective Response (ORR) Per Response Evaluation Criteria In Solid Tumors (RECIST) Version (v) 1.1 as Assessed by Independent Review Facility (IRF) | Cohort 1: First Line Atezolizumab | TC3 or IC2/3 Responders | 21.1 | 95% Confidence Interval 14.3 to 29.4 | percentage of participants |
| Percentage of Participants Achieving Objective Response (ORR) Per Response Evaluation Criteria In Solid Tumors (RECIST) Version (v) 1.1 as Assessed by Independent Review Facility (IRF) | Cohort 2: Second Line Atezolizumab | TC3 or IC2/3 Responders | 17.4 | 95% Confidence Interval 12.9 to 22.7 | percentage of participants |
| Percentage of Participants Achieving Objective Response (ORR) Per Response Evaluation Criteria In Solid Tumors (RECIST) Version (v) 1.1 as Assessed by Independent Review Facility (IRF) | Cohort 3: Third Line and Beyond Atezolizumab | TC3 or IC2/3 Responders | 18.2 | 95% Confidence Interval 13.5 to 23.8 | percentage of participants |
| Percentage of Participants Achieving Objective Response (ORR) Per Response Evaluation Criteria In Solid Tumors (RECIST) Version (v) 1.1 as Assessed by Independent Review Facility (IRF) | Cohorts 2 + 3 | TC3 or IC2/3 Responders | 17.8 | 95% Confidence Interval 14.5 to 21.5 | percentage of participants |
| Percentage of Participants Achieving Objective Response (ORR) Per Response Evaluation Criteria In Solid Tumors (RECIST) Version (v) 1.1 as Assessed by Independent Review Facility (IRF) | Cohort 1: First Line Atezolizumab | TC2/3 or IC2/3 Responders | 19.4 | 95% Confidence Interval 13.2 to 27.0 | percentage of participants |
| Percentage of Participants Achieving Objective Response (ORR) Per Response Evaluation Criteria In Solid Tumors (RECIST) Version (v) 1.1 as Assessed by Independent Review Facility (IRF) | Cohort 2: Second Line Atezolizumab | TC2/3 or IC2/3 Responders | 17.2 | 95% Confidence Interval 12.9 to 22.3 | percentage of participants |
1 to 10 of 246Source ClinicalTrials.gov
See all 246 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| May 8, 2015 to January 11, 2019 | STARTED | Cohort 1: First Line Atezolizumab | 138 | |
| May 8, 2015 to January 11, 2019 | STARTED | Cohort 2: Second Line Atezolizumab | 269 | |
| May 8, 2015 to January 11, 2019 | STARTED | Cohort 3: Third Line and Beyond Atezolizumab | 252 | |
| May 8, 2015 to January 11, 2019 | COMPLETED | Cohort 1: First Line Atezolizumab | 0 | |
| May 8, 2015 to January 11, 2019 | COMPLETED | Cohort 2: Second Line Atezolizumab | 0 | |
| May 8, 2015 to January 11, 2019 | COMPLETED | Cohort 3: Third Line and Beyond Atezolizumab | 0 | |
| May 8, 2015 to January 11, 2019 | NOT COMPLETED | Cohort 1: First Line Atezolizumab | 138 | |
| May 8, 2015 to January 11, 2019 | NOT COMPLETED | Cohort 2: Second Line Atezolizumab | 269 | |
| May 8, 2015 to January 11, 2019 | NOT COMPLETED | Cohort 3: Third Line and Beyond Atezolizumab | 252 | |
| Baseline to May 8, 2015 | STARTED | Cohort 1: First Line Atezolizumab | 139 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events771
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort 1: First Line Atezolizumab | 17 | 138 | 33 |
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort 2: Second Line Atezolizumab | 31 | 269 | 54 |
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort 3: Third Line and Beyond Atezolizumab | 22 | 252 | 41 |
| other | HYPOTHYROIDISM | Endocrine disorders | Cohort 1: First Line Atezolizumab | 8 | 138 | 10 |
| other | HYPOTHYROIDISM | Endocrine disorders | Cohort 2: Second Line Atezolizumab | 15 | 269 | 16 |
| other | HYPOTHYROIDISM | Endocrine disorders | Cohort 3: Third Line and Beyond Atezolizumab | 10 | 252 | 16 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Cohort 1: First Line Atezolizumab | 10 | 138 | 12 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Cohort 2: Second Line Atezolizumab | 22 | 269 | 27 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Cohort 3: Third Line and Beyond Atezolizumab | 18 | 252 | 24 |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Cohort 1: First Line Atezolizumab | 5 | 138 | 7 |
1 to 10 of 771Source ClinicalTrials.gov
See all 771 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: First Line Atezolizumab | 89 | 138 |
| Total, all-cause mortality | Cohort 2: Second Line Atezolizumab | 193 | 269 |
| Total, all-cause mortality | Cohort 3: Third Line and Beyond Atezolizumab | 198 | 252 |
| Total, other adverse events | Cohort 1: First Line Atezolizumab | 116 | 138 |
| Total, other adverse events | Cohort 2: Second Line Atezolizumab | 229 | 269 |
| Total, other adverse events | Cohort 3: Third Line and Beyond Atezolizumab | 229 | 252 |
| Total, serious adverse events | Cohort 1: First Line Atezolizumab | 47 | 138 |
| Total, serious adverse events | Cohort 2: Second Line Atezolizumab | 117 | 269 |
| Total, serious adverse events | Cohort 3: Third Line and Beyond Atezolizumab | 113 | 252 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02031458
GET https://conductscience.org/api/trials/v1/NCT02031458/registered?page=2