A Study of Atezolizumab in Participants With Programmed Death-Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) [FIR]

NCT01846416 | Completed Phase 2 Results

• 2 other identifiers: GO286252013-000177-69
• Study Type: interventional
• Target: 138
• Locations: 5 countries
• Sites: 31

Brief Summary

This multicenter, single-arm study will evaluate the efficacy and safety of atezolizumab (MPDL3280A) in participants with PD-L1-positive locally advanced or metastatic NSCLC. Participants will receive an intravenous (IV) dose of 1200 milligrams (mg) atezolizumab (MPDL3280A) on Day 1 of 21-day cycles until disease progression. Eligible participants will be categorized in to three groups as follows:

1. 1.Participants with no prior chemotherapy for advanced disease;
2. 2.Participants who progress during or following a prior-platinum based chemotherapy regimen for advanced disease (2L+participants);
3. 3.Participants who are 2L+ and previously treated for brain metastases.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Objective Response According to Modified Response Evaluation Criteria in Solid Tumors (RECIST)

  Objective response was defined as a complete response (CR) or partial response (PR), as determined by investigator according to modified RECIST criteria. Modified RECIST was derived from RECIST v1.1 conventions and immune related response criteria. CR was defined as disappearance of all tumor lesions (target lesion \[TL\] and non-target lesion \[non-TL\]) and no new measurable or unmeasurable lesions, all lymph node short axes must be less than 10 millimeters (mm), and PR was defined as at least 30 percent (%) decrease in sum of diameter of TLs and all new measurable lesions since baseline in absence of CR, and both confirmed by consecutive assessment greater than or equal to 4 weeks from date first documented. Participants not meeting these criteria, including participants without at least one post-baseline response assessment were considered as non-responders.

  Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)

Secondary Outcomes (13)

• Percentage of Participants With Objective Response According to RECIST Version 1.1 (v1.1)

  Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)

• Duration of Objective Response According to RECIST v1.1

  Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)

• Percentage of Participants With 6-Month Duration of Objective Response

  Month 6

• Percentage of Participants With Disease Progression or Death According to RECIST v1.1

  Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)

• Progression-Free Survival (PFS) According to RECIST v1.1

  Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)

Study Arms (3)

Atezolizumab (MPDL3280): 1L Participants

EXPERIMENTAL

Participants with no prior chemotherapy for advanced NSCLC disease will receive atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.

Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody

Atezolizumab (MPDL3280): 2L+ Participants

EXPERIMENTAL

Participants who progress during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies will receive atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.

Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody

Atezolizumab (MPDL3280): 2L+ Brain Metastases Participants

EXPERIMENTAL

Participants with previously treated brain metastases and who progress during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, will receive atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.

Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody

Interventions

Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody DRUG

Atezolizumab 1200 mg IV on Day 1 of each 21-day cycle until disease progression.

Atezolizumab (MPDL3280): 1L Participants; Atezolizumab (MPDL3280): 2L+ Brain Metastases Participants; Atezolizumab (MPDL3280): 2L+ Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage IIIB (not eligible for definitive chemoradiotherapy), Stage IV, or recurrent NSCLC
• PDL1-positive status as determined by an immunohistochemistry assay performed by a central laboratory. A positive result in chemotherapy, chemoradiation of the tumor sample biopsy will satisfy the eligibility criterion
• Eastern Cooperative Oncology group Performance Status of 0 or 1
• Life expectancy greater than or equal to 12 weeks
• Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors Version 1.1
• Adequate hematologic and end organ function

You may not qualify if:

• Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exceptions are allowed. Hormone-replacement therapy or oral contraceptives, and tyrosine kinase inhibitors approved for treatment of NSCLC discontinued greater than 7 days prior to Cycle 1 Day 1
• Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
• Known central nervous system disease, including treated brain metastases in the following participants:
• who will not receive prior chemotherapy for advanced disease
• who progress during or following a prior-platinum based chemotherapy regimen for advanced disease (referred as 2L+ participants)
• Participants with a history of treated asymptomatic brain metastases are allowed in the 2L+ participants and previously treated for brain metastases.
• Leptomeningeal disease
• Uncontrolled tumor-related pain
• Uncontrolled hypercalcemia

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (31)

HonorHealth Research Institute - Pima Center

Scottsdale, Arizona, 85258, United States

Location

Stanford University/Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

The Angeles Clinic and Research Institute, Santa Monica Office

Santa Monica, California, 90025, United States

Location

University Of Colorado

Aurora, Colorado, 80045, United States

Location

Yale University School Of Medicine

New Haven, Connecticut, 06510, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Florida Hospital Cancer Inst

Orlando, Florida, 32804, United States

Location

Hematology Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, 34952, United States

Location

Florida Cancer Specialists.

St. Petersburg, Florida, 33705, United States

Location

H. Lee Moffitt Cancer Center and Research Inst.

Tampa, Florida, 33612, United States

Location

Northwest Georgia Oncology Centers P.C.

Carrollton, Georgia, 30117, United States

Location

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Dartmouth Hitchcock Med Center; Norris Cotton Cancer Ctr

Lebanon, New Hampshire, 03756, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Duke University Health Systems

Durham, North Carolina, 27710, United States

Location

Carolina BioOncology Institute; Can Therapy & Res Ctr

Huntersville, North Carolina, 28078, United States

Location

Ohio State Uni Hospital

Columbus, Ohio, 43210-1250, United States

Location

Oncology Hematology Care, Inc.

Hamilton, Ohio, 45103, United States

Location

Penn State Univ. Milton S. Hershey Medical Center; MSHMC Cardiology

Hershey, Pennsylvania, 17033, United States

Location

Penn Presbyterian Medical Center; Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

SCRI-Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Huntsman Cancer Institute; University of Utah

Salt Lake City, Utah, 84112, United States

Location

Virginia Cancer Institute

Richmond, Virginia, 23226, United States

Location

University of Washington Seattle Cancer Care Alliance

Seattle, Washington, 98195, United States

Location

Sint Augustinus Wilrijk

Wilrijk, 2610, Belgium

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Antoni van Leeuwenhoek Ziekenhuis

Amsterdam, 1066 CX, Netherlands

Location

Queen Mary University of London

London, EC1M 6BQ, United Kingdom

Location

Royal Marsden Hospital - Fulham; Oncology Department

London, SW3 6JJ, United Kingdom

Location

Royal Marsden Hospital - Fulham

London, SW3 6JJ, United Kingdom

Location

Related Publications (1)

• Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685.

  PMID: 33241650 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2013
• First Posted: May 3, 2013
• Study Start: May 30, 2013
• Primary Completion: January 7, 2015
• Study Completion: December 18, 2017
• Last Updated: January 8, 2019
• Results First Posted: December 16, 2016

Record last verified: 2018-12

Locations

US (25); GB (3); BE (1); FR (1); NL (1)