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 : May 17, 2021
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||181 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Open-Label, Multicenter, Single-Arm Study to Investigate the Efficacy and Safety of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Patients With Stage IB, II, IIIA, or Selected IIIB Resectable and Untreated Non-Small Cell Lung Cancer|
|Actual Study Start Date :||April 20, 2017|
|Actual Primary Completion Date :||May 7, 2020|
|Estimated Study Completion Date :||May 3, 2025|
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 atezolizumab.
Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Atezolizumab was given as 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of each 21-day cycle.
Other Name: RO5541267, MPDL3280A
- Percentage of Participants With Major Pathologic Response (MPR) [ Time Frame: After surgery (approximately 10 weeks) ]Major pathologic response (defined as ≤ 10% of viable tumor cells), scored by a pathologist, based on surgical resection as defined by prior studies.
- Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: After surgery (approximately 10 weeks) ]Objective response rate is the proportion of participants who are objective responders (Complete Response and Partial Response are considered as responders, Stable Disease, Progressive Disease and Not Evaluable are considered as nonresponders) in the PD-L1 positive (TC123IC123) and negative (TC0IC0) groups.
- Percentage of Participants With Major Pathologic Response Rates For Programmed Death Ligand 1 (PD-L1)-Positive Versus PD-L1-Negative Participants [ Time Frame: After surgery (approximately 10 weeks) ]Major pathologic response (defined as ≤ 10% of viable tumor cells), scored by a pathologist, based on surgical resection as defined by prior studies.
- Percentage of Participants With Adverse Events [ Time Frame: From Baseline until 90 days after end of treatment (approximately 16.5 months overall) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927301
|Study Director:||Clinical Trials||Hoffmann-La Roche|