A Study of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Resectable Non-Small Cell Lung Cancer (NSCLC) - Lung Cancer Mutation Consortium (LCMC3)
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ClinicalTrials.gov Identifier: NCT02927301 |
Recruitment Status :
Active, not recruiting
First Posted : October 7, 2016
Results First Posted : May 17, 2021
Last Update Posted : August 2, 2022
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Sponsor:
Genentech, Inc.
Information provided by (Responsible Party):
Genentech, Inc.
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Non-Small Cell Lung Cancer |
Intervention |
Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody |
Enrollment | 181 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
The study was conducted in two parts, a Neoadjuvant Atezolizumab Therapy Phase and an Adjuvant Atezolizumab Therapy Phase. Neoadjuvant therapy consisted of two 21-day cycles with atezolizumab. Following surgery, adjuvant therapy consisted of up to 12 months of atezolizumab in participants who demonstrate clinical benefit with adjuvant therapy. Participant Flow data are for the Neoadjuvant Atezo Therapy Phase. Adjuvant Atezo Therapy Phase data are not final as study is ongoing. |
Arm/Group Title | Atezolizumab |
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Participants received two cycles of atezolizumab as neoadjuvant therapy prior to surgery. Participants who demonstrated clinical benefit were eligible to receive up to 12 months of adjuvant atezolizumab. |
Period Title: Overall Study | |
Started | 181 |
Completed | 171 |
Not Completed | 10 |
Reason Not Completed | |
Adverse Event | 7 |
Withdrawal by Subject | 1 |
Physician Decision | 2 |
Baseline Characteristics
Arm/Group Title | Atezolizumab | |
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Participants received two cycles of atezolizumab as neoadjuvant therapy prior to surgery. Participants who demonstrated clinical benefit were eligible to receive up to 12 months of adjuvant atezolizumab. | |
Overall Number of Baseline Participants | 181 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 181 participants | |
65.1 (9.23) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 181 participants | |
Female |
93 51.4%
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Male |
88 48.6%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 181 participants | |
Hispanic or Latino |
8 4.4%
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Not Hispanic or Latino |
159 87.8%
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Unknown or Not Reported |
14 7.7%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 181 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
9 5.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
13 7.2%
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White |
145 80.1%
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More than one race |
0 0.0%
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Unknown or Not Reported |
14 7.7%
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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: | Genentech |
Phone: | 800-821-8590 |
EMail: | genentech@druginfo.com |
Responsible Party: | Genentech, Inc. |
ClinicalTrials.gov Identifier: | NCT02927301 |
Other Study ID Numbers: |
ML39236 |
First Submitted: | October 5, 2016 |
First Posted: | October 7, 2016 |
Results First Submitted: | April 23, 2021 |
Results First Posted: | May 17, 2021 |
Last Update Posted: | August 2, 2022 |