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]

NCT ID: NCT01846416

Last Updated: 2019-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-30
• Study Completion Date: 2017-12-18

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. Participants with no prior chemotherapy for advanced disease;

2. Participants who progress during or following a prior-platinum based chemotherapy regimen for advanced disease (2L+participants);

3. Participants who are 2L+ and previously treated for brain metastases.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Atezolizumab (MPDL3280): 1L Participants

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Atezolizumab (MPDL3280): 2L+ Participants

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Atezolizumab (MPDL3280): 2L+ Brain Metastases Participants

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Interventions

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

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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:

1. who will not receive prior chemotherapy for advanced disease

2. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

HonorHealth Research Institute - Pima Center

Scottsdale, Arizona, United States

Stanford University/Lucile Packard Children's Hospital

Palo Alto, California, United States

The Angeles Clinic and Research Institute, Santa Monica Office

Santa Monica, California, United States

University Of Colorado

Aurora, Colorado, United States

Yale University School Of Medicine

New Haven, Connecticut, United States

Georgetown University

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

Florida Hospital Cancer Inst

Orlando, Florida, United States

Hematology Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, United States

Florida Cancer Specialists.

St. Petersburg, Florida, United States

H. Lee Moffitt Cancer Center and Research Inst.

Tampa, Florida, United States

Northwest Georgia Oncology Centers P.C.

Carrollton, Georgia, United States

The University of Chicago Medical Center

Chicago, Illinois, United States

Dartmouth Hitchcock Med Center; Norris Cotton Cancer Ctr

Lebanon, New Hampshire, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Duke University Health Systems

Durham, North Carolina, United States

Carolina BioOncology Institute; Can Therapy & Res Ctr

Huntersville, North Carolina, United States

Ohio State Uni Hospital

Columbus, Ohio, United States

Oncology Hematology Care, Inc.

Hamilton, Ohio, United States

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

Hershey, Pennsylvania, United States

Penn Presbyterian Medical Center; Abramson Cancer Center

Philadelphia, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

SCRI-Tennessee Oncology

Nashville, Tennessee, United States

Huntsman Cancer Institute; University of Utah

Salt Lake City, Utah, United States

Virginia Cancer Institute

Richmond, Virginia, United States

University of Washington Seattle Cancer Care Alliance

Seattle, Washington, United States

Sint Augustinus Wilrijk

Wilrijk, , Belgium

Centre Léon Bérard

Lyon, , France

Antoni van Leeuwenhoek Ziekenhuis

Amsterdam, , Netherlands

Queen Mary University of London

London, , United Kingdom

Royal Marsden Hospital - Fulham; Oncology Department

London, , United Kingdom

Royal Marsden Hospital - Fulham

London, , United Kingdom

Countries

United States; Belgium; France; Netherlands; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 33241650 (View on PubMed)

Other Identifiers

2013-000177-69

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GO28625

Identifier Type: -

Identifier Source: org_study_id