A Study of Atezolizumab Compared With a Single-Agent Chemotherapy in Treatment Naïve Participants With Locally Advanced or Recurrent or Metastatic Non-Small Cell Lung Cancer Who Are Deemed Unsuitable For Platinum-Doublet Chemotherapy (IPSOS)
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| ClinicalTrials.gov Identifier: NCT03191786 |
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Recruitment Status :
Completed
First Posted : June 19, 2017
Results First Posted : May 17, 2023
Last Update Posted : November 7, 2023
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
- Study Details
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Non-Small Cell Lung Cancer |
| Interventions |
Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody Drug: Vinorelbine Drug: Gemcitabine |
| Enrollment | 453 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Atezolizumab | Single Agent Chemotherapy (Vinorelbine or Gemcitabine) |
|---|---|---|
 Arm/Group Description |
Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion on Day 1 of each 21-day cycle until loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death. | Participants received single agent chemotherapy; either vinorelbine oral or IV, or gemcitabine IV, according to the label based on investigator's choice. |
| Period Title: Overall Study | ||
| Started | 302 | 151 |
| Completed | 15 | 0 |
| Not Completed | 287 | 151 |
| Reason Not Completed | ||
| Death | 236 | 127 |
| Lost to Follow-up | 9 | 3 |
| Physician Decision | 1 | 0 |
| Study Terminated By Sponsor | 15 | 5 |
| Withdrawal by Subject | 26 | 16 |
Baseline Characteristics
| Arm/Group Title | Atezolizumab | Single Agent Chemotherapy (Vinorelbine or Gemcitabine) | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion on Day 1 of each 21-day cycle until loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death. | Participants received single agent chemotherapy; either vinorelbine oral or IV, or gemcitabine IV, according to the label based on investigator's choice. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 302 | 151 | 453 | |
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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 | 302 participants | 151 participants | 453 participants | |
| 73.6 (9.1) | 73.8 (8.5) | 73.7 (8.9) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 302 participants | 151 participants | 453 participants | |
| Female |
82 27.2%
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43 28.5%
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125 27.6%
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| Male |
220 72.8%
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108 71.5%
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328 72.4%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 302 participants | 151 participants | 453 participants | |
| Hispanic or Latino |
47 15.6%
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23 15.2%
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70 15.5%
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| Not Hispanic or Latino |
242 80.1%
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125 82.8%
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367 81.0%
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| Unknown or Not Reported |
13 4.3%
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3 2.0%
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16 3.5%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 302 participants | 151 participants | 453 participants | |
| American Indian or Alaska Native |
12 4.0%
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9 6.0%
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21 4.6%
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| Asian |
75 24.8%
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38 25.2%
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113 24.9%
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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 |
2 0.7%
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1 0.7%
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3 0.7%
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| White |
203 67.2%
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95 62.9%
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298 65.8%
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| More than one race |
6 2.0%
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6 4.0%
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12 2.6%
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| Unknown or Not Reported |
4 1.3%
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2 1.3%
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6 1.3%
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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 |
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT03191786 |
| Other Study ID Numbers: |
MO29872 2015-004105-16 ( EudraCT Number ) |
| First Submitted: | June 15, 2017 |
| First Posted: | June 19, 2017 |
| Results First Submitted: | April 18, 2023 |
| Results First Posted: | May 17, 2023 |
| Last Update Posted: | November 7, 2023 |