A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower130)
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ClinicalTrials.gov Identifier: NCT02367781 |
Recruitment Status :
Completed
First Posted : February 20, 2015
Results First Posted : April 3, 2019
Last Update Posted : August 9, 2021
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Carcinoma, Non-Squamous Non-Small Cell Lung |
Interventions |
Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody Drug: Carboplatin Drug: Nab-Paclitaxel Drug: Pemetrexed |
Enrollment | 723 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Participants in this study included: histologically or cytologically confirmed, Stage IV non-squamous NSCLC; and no prior treatment for Stage IV non-squamous NSCLC. At the time of study completion a few participants that were still on maintenance treatment with atezolizumab were moved to another study, Post-Trial Access Program, or commercial use. Therefore, the reason for discontinuation was entered "Study terminated by Sponsor" for these participants. |
Arm/Group Title | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | Arm B (Nab-Paclitaxel+Carboplatin) |
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Arm/Group Description | Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit. | Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression. |
Period Title: Overall Study | ||
Started | 483 | 240 |
Completed | 0 | 0 |
Not Completed | 483 | 240 |
Reason Not Completed | ||
Withdrawal by Subject | 20 | 13 |
Protocol Violation | 0 | 1 |
Physician Decision | 7 | 0 |
Randomized in Error | 5 | 4 |
Non-Compliance | 1 | 0 |
Lost to Follow-up | 1 | 2 |
Death | 330 | 176 |
Patient Moving to Roll-Over Study | 17 | 5 |
Prolonged Hospitalization | 1 | 0 |
Death Prior First Dose | 1 | 0 |
Administrative-Change Facility | 1 | 0 |
Request From Sponsor to Withdraw Patient in Survival Follow-Up | 78 | 29 |
Patient Moved to Commercial Atezolizumab Use | 14 | 9 |
Study Terminated by Sponsor | 3 | 1 |
Patient Admitted to Hospital & Couldn't be Dosed for Randomization | 1 | 0 |
Sponsor Decision | 2 | 0 |
3 Year Treatment Completed, Immunotherapy Paused, Continuing Follow-Up Planned | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | Arm B (Nab-Paclitaxel+Carboplatin) | Total | |
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Arm/Group Description | Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit. | Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression. | Total of all reporting groups | |
Overall Number of Baseline Participants | 483 | 240 | 723 | |
Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 483 participants | 240 participants | 723 participants | |
63.8 (9.5) | 64.4 (8.9) | 64.0 (9.3) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 483 participants | 240 participants | 723 participants | |
Female |
206 42.7%
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102 42.5%
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308 42.6%
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Male |
277 57.3%
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138 57.5%
|
415 57.4%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 483 participants | 240 participants | 723 participants | |
Hispanic or Latino |
25 5.2%
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12 5.0%
|
37 5.1%
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|
Not Hispanic or Latino |
426 88.2%
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213 88.8%
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639 88.4%
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Unknown or Not Reported |
32 6.6%
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15 6.3%
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47 6.5%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 483 participants | 240 participants | 723 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
|
0 0.0%
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|
Asian |
14 2.9%
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3 1.3%
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17 2.4%
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|
Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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|
Black or African American |
18 3.7%
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8 3.3%
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26 3.6%
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White |
428 88.6%
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222 92.5%
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650 89.9%
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More than one race |
2 0.4%
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0 0.0%
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2 0.3%
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Unknown or Not Reported |
21 4.3%
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7 2.9%
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28 3.9%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: | Medical Communications |
Organization: | Hoffmann-La Roche |
Phone: | 800-821-8590 |
EMail: | genentech@druginfo.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT02367781 |
Other Study ID Numbers: |
GO29537 2014-003206-32 ( EudraCT Number ) |
First Submitted: | February 13, 2015 |
First Posted: | February 20, 2015 |
Results First Submitted: | March 13, 2019 |
Results First Posted: | April 3, 2019 |
Last Update Posted: | August 9, 2021 |