Atezolizumab Immunotherapy in Patients With Advanced NSCLC

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Alliance Foundation Trials, LLC.
Study ID
NCT03102242
Phase
PHASE2
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Single arm phase II trial of induction immunotherapy with anti-PD-L1 for patients with unresectable stage III NSCLC and PS 0-1.

Study Details

Phase II trial of induction immunotherapy with atezolizumab for patients with unresectable stage IIIA and IIIB NSCLC eligible for chemoradiotherapy with curative intent.

Key Dates

Start date
Nov 1, 2017
Status verified
Apr 2023
Primary completion
Jun 1, 2020
Completion
Oct 1, 2022

Study Design

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

Arms

  • Experimental: Treatment
    Induction immunotherapy: atezolizumab 1200 mg IV q 21 days x 4 cycles. Restaging after cycle 2 and cycle 4 induction: patients with progression of disease (PD) at the post-cycle 2 assessment will stop atezolizumab and go immediately to chemoradiotherapy if still stage III and eligible for curative intent therapy. Chemoradiotherapy: carboplatin AUC = 2 + paclitaxel 50 mg/m2 IV weekly x 6 weeks concurrent with radiation to a total dose of 60 Gy given in 2 Gy fractions daily M-F x 30 fractions Consolidation chemotherapy: Carboplatin AUC = 6 + paclitaxel 200 mg/m2 IV q 21 days x 2 cycles beginning 3-5 weeks after completion of radiation. Adjuvant immunotherapy: atezolizumab 1200 mg IV q 21 days to complete one year of therapy (from start of induction).

Primary Outcome Measure

Disease Control Rate (DCR) After 12 Weeks Induction [ Time Frame: 12 weeks ]

Locations (13)

FacilityCityStateZIPSite coordinators
Mayo Clinic HospitalPhoenixArizona85054-
UCSD Moores Cancer CenterLa JollaCalifornia92037-
The University of Chicago Medical CenterChicagoIllinois60637-
EMMC Cancer CareBrewerMaine04412-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Saint Joseph Mercy HospitalAnn ArborMichigan48106-
Metro MN Community Oncology Research ConsortiumMinneapolisMinnesota55416-
Washington University School of MedicineSt LouisMissouri63110-
SUNY Upstate Medical UniversitySyracuseNew York13210-
Ohio State University James Cancer CenterColumbusOhio43210-
Lankenau Medical CenterWynnewoodPennsylvania19096-
Prisma Health Greenville Memorial HospitalGreenvilleSouth Carolina29605-
University of Virginia Cancer CenterCharlottesvilleVirginia22908-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic Hospital· Phoenix, AZUCSD Moores Cancer Center· La Jolla, CAThe University of Chicago Medical Center· Chicago, ILEMMC Cancer Care· Brewer, MEDana-Farber Cancer Institute· Boston, MASaint Joseph Mercy Hospital· Ann Arbor, MI

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