A Study of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Resectable Non-Small Cell Lung Cancer (NSCLC) - Lung Cancer Mutation Consortium (LCMC3)
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
1 other identifier
interventional
181
1 country
19
Brief Summary
This study was designed to evaluate the safety and efficacy of neoadjuvant and adjuvant atezolizumab in participants with resectable Non-Small Cell Lung Cancer (NSCLC). 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 neoadjuvant therapy. All participants who undergo surgery entered a surveillance period, which consisted of standardized blood sample collection and Chest CT Scans, for up to 2 years. All participants were monitored for disease recurrence and survival for up to 3 years after last dose of study drug.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
Started Apr 2017
Longer than P75 for phase_2 nonsmall-cell-lung-cancer
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2016
CompletedFirst Posted
Study publicly available on registry
October 7, 2016
CompletedStudy Start
First participant enrolled
April 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 7, 2020
CompletedResults Posted
Study results publicly available
May 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 5, 2023
CompletedSeptember 19, 2024
August 1, 2024
3 years
October 5, 2016
April 23, 2021
August 16, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Major Pathologic Response (MPR)
Major pathologic response was defined as ≤10% of viable tumor cells as scored by a pathologist, based on surgical resection as defined by prior studies. Percentages have been rounded off to the nearest decimal point.
After surgery (approximately 10 weeks)
Secondary Outcomes (7)
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) for PD-L1-Positive Versus PD-L1-Negative Participants
Pre-surgery (Day 36 +/- 3 days), after 2 doses of neoadjuvant treatment with atezolizumab
Percentage of Participants With Major Pathologic Response for PD-L1-Positive Versus PD-L1-Negative Participants
After surgery (approximately 10 weeks)
Number of Participants With at Least One Adverse Event
From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months)
Percentage of Participants With Major Pathologic Response (MPR) by Mutation Load
Up to 13 weeks
Percentage of Participants With Major Pathologic Response (MPR) by Neoantigen Score
Up to 13 weeks
- +2 more secondary outcomes
Study Arms (1)
Atezolizumab
EXPERIMENTALParticipants 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.
Interventions
Atezolizumab was given as 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of each 21-day cycle.
Eligibility Criteria
You may qualify if:
- Pathologically documented Stage IB, II, IIIA, or selected IIIB, including T3N2 or T4 (by size criteria, not by mediastinal invasion) NSCLC
- Adequate pulmonary and cardiac function
- Available biopsy of primary tumor with adequate samples
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
You may not qualify if:
- NSCLC that is clinically T4 by virtue of mediastinal organ invasion or Stage IIIB by virtue of N3 disease
- Any prior therapy for lung cancer within 3 years.
- Prior treatment with anti-PD-1 or PD-L1 therapies
- History or risk of autoimmune disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (19)
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
UCLA Cancer Center
Santa Monica, California, 90404, United States
University Of Colorado
Aurora, Colorado, 80045, United States
Yale Cancer Center
New Haven, Connecticut, 06520, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Emory University; Winship Cancer Institute
Atlanta, Georgia, 30308, United States
Dana Farber Cancer Institute; Brigham and Womens Hospital
Boston, Massachusetts, 02115, United States
Mass General/North Shore Cancer
Danvers, Massachusetts, 01923, United States
Karmanos Cancer Inst; Hematology/Oncology
Detroit, Michigan, 48201, United States
Washington University; Wash Uni. Sch. Of Med
St Louis, Missouri, 63110, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Memorial Sloan Kettering - Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Cancer Center - Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Cancer Center at Westchester
Harrison, New York, 10604, United States
New York University Medical Center
New York, New York, 10036, United States
Memorial Sloan Kettering - Basking Ridge
New York, New York, 10065, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Related Publications (1)
Chaft JE, Oezkan F, Kris MG, Bunn PA, Wistuba II, Kwiatkowski DJ, Owen DH, Tang Y, Johnson BE, Lee JM, Lozanski G, Pietrzak M, Seweryn M, Byun WY, Schulze K, Nicholas A, Johnson A, Grindheim J, Hilz S, Shames DS, Rivard C, Toloza E, Haura EB, McNamee CJ, Patterson GA, Waqar SN, Rusch VW, Carbone DP; LCMC study investigators. Neoadjuvant atezolizumab for resectable non-small cell lung cancer: an open-label, single-arm phase II trial. Nat Med. 2022 Oct;28(10):2155-2161. doi: 10.1038/s41591-022-01962-5. Epub 2022 Sep 12.
PMID: 36097216DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Genentech
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2016
First Posted
October 7, 2016
Study Start
April 20, 2017
Primary Completion
May 7, 2020
Study Completion
September 5, 2023
Last Updated
September 19, 2024
Results First Posted
May 17, 2021
Record last verified: 2024-08