A Study of Atezolizumab as First-line Monotherapy for Advanced or Metastatic Non-Small Cell Lung Cancer

Part of paid clinical trials in Fresno, California.

Sponsor
Genentech, Inc.
Study ID
NCT02848651
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Atezolizumab 1200 mg was administered by intravenous infusion on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).

Study Details

This was a Phase II, open-label, prospective, multicenter study designed to evaluate the efficacy and safety of single-agent atezolizumab as a first-line therapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC). In addition, the primary biomarker objective was to measure blood tumor mutational burden (bTMB) and evaluate whether it can predict for improved clinical outcome with atezolizumab.

Key Dates

Start date
Sep 23, 2016
Status verified
Apr 2020
Primary completion
May 14, 2019
Completion
May 14, 2019

Study Design

Enrollment
153 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab
    Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).

Primary Outcome Measure

Percentage of Participants With Objective Response Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Determined by Investigator [ Time Frame: Baseline up to 32 months ]

Locations (20)

FacilityCityStateZIPSite coordinators
Veterans Affairs Central California Health Care SystemFresnoCalifornia93703-
Memorial Regional HospitalHollywoodFlorida33021-
Florida HospitalOrlandoFlorida32803-
St. Alexius Medical CenterHoffman EstatesIllinois60169-
Quincy Medical Group; Canc Ctr at Blessing HospQuincyIllinois62301-
Franciscan St. Francis Health; Research ServicesIndianapolisIndiana46237-
Cancer Center of KansasWichitaKansas67214-
Michigan Cancer Rsch ConsYpsilantiMichigan48197-
Virginia Piper Cancer InstMinneapolisMinnesota55407-
San Juan Oncology AssociatesFarmingtonNew Mexico87401-
Stony Brook University Medical CenterStony BrookNew York11794-
Eastchester Center for Cancer CareThe BronxNew York10469-
Levine Cancer Institute-Carolinas Medical Center; Levine Cancer Institute-Carolinas Medical CenterCharlotteNorth Carolina28204-
The Cleveland Clinic FoundationClevelandOhio44195-
Cancer Treatment Centers of America - Eastern Regional Medical CenterPhiladelphiaPennsylvania19124-
Avera Research InstituteSioux FallsSouth Dakota57105-
Univ of Texas SW Medical CtrDallasTexas75390-
Inova Health Care ServicesFalls ChurchVirginia22042-
Western WA Oncology Inc PSLaceyWashington98503-
University of WisconsinMadisonWisconsin53792-

Find similar trials in Fresno, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Veterans Affairs Central California Health Care System· Fresno, CAMemorial Regional Hospital· Hollywood, FLFlorida Hospital· Orlando, FLSt. Alexius Medical Center· Hoffman Estates, ILQuincy Medical Group; Canc Ctr at Blessing Hosp· Quincy, ILFranciscan St. Francis Health; Research Services· Indianapolis, IN

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