A Study of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Resectable Non-Small Cell Lung Cancer (NSCLC) - Lung Cancer Mutation Consortium (LCMC3)

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02927301
• Other study ID #: ML39236
• Status: Completed
• Phase: Phase 2
• Start date: April 20, 2017
• Est. completion date: September 5, 2023

Study information

• Verified date: January 2024
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: September 5, 2023
• Est. primary completion date: May 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University; Winship Cancer Institute	Atlanta	Georgia
United States	University Of Colorado	Aurora	Colorado
United States	Dana Farber Cancer Institute; Brigham and Womens Hospital	Boston	Massachusetts
United States	The Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	Memorial Sloan Kettering Cancer Center - Commack	Commack	New York
United States	Mass General/North Shore Cancer	Danvers	Massachusetts
United States	Karmanos Cancer Inst; Hematology/Oncology	Detroit	Michigan
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	Memorial Sloan Kettering Cancer Center at Westchester	Harrison	New York
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Memorial Sloan Kettering - Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen	Montvale	New Jersey
United States	Yale Cancer Center	New Haven	Connecticut
United States	Memorial Sloan Kettering - Basking Ridge	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Cancer Center; Memorial Sloan Kettering Cancer Center - Koch	New York	New York
United States	New York University Medical Center	New York	New York
United States	Washington University; Wash Uni. Sch. Of Med	Saint Louis	Missouri
United States	UCLA Cancer Center	Santa Monica	California
United States	Moffitt Cancer Center	Tampa	Florida
United States	Memorial Sloan Kettering Nassau	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Major Pathologic Response (MPR)	Major pathologic response (defined as = 10% of viable tumor cells), scored by a pathologist, based on surgical resection as defined by prior studies.	After surgery (approximately 10 weeks)
Secondary	Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1	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.	After surgery (approximately 10 weeks)
Secondary	Percentage of Participants With Major Pathologic Response Rates For Programmed Death Ligand 1 (PD-L1)-Positive Versus PD-L1-Negative Participants	Major pathologic response (defined as = 10% of viable tumor cells), scored by a pathologist, based on surgical resection as defined by prior studies.	After surgery (approximately 10 weeks)
Secondary	Percentage of Participants With Adverse Events		From Baseline until 90 days after end of treatment (approximately 16.5 months overall)