Evaluating the Efficacy of Atezolizumab in Advanced Non-small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Orlando, Florida.

Sponsor
Liza Villaruz, MD
Study ID
NCT03014648
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Non-small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab will be administered through an IV over 60 minutes at a dose of 1200mg on Day 1 of each 21-day cycle. If the first dose is tolerated without any infusion-related adverse events, the following doses can be administered over 30 minutes.

Study Details

This is a phase II clinical trial aimed at evaluating the efficacy of PD-L1 inhibition with atezolizumab in advanced squamous and non-squamous NSCLC patients previously treated with anti-PD-1 therapy with either nivolumab or pembrolizumab. In order to account for the variability of response kinetics to PD-1 directed therapy, patients will be enrolled in 3 parallel cohorts based on the best overall response to PD-1 directed therapy. * Cohort 1 (progressive disease) * Cohort 2 (stable disease with minimum 12 weeks of therapy) * Cohort 3 (partial to complete response followed by progressive disease)

Key Dates

Start date
Jul 18, 2017
Status verified
Nov 2023
Primary completion
Dec 31, 2021
Completion
Mar 31, 2022

Study Design

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

Arms

  • Experimental: Atezolizumab
    Atezolizumab will be given on day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion; can be decreased to 30 (plus or minus 10) minutes for subsequent cycles. Atezolizumab will be given as long as the patient continues to experience clinical benefit in the opinion of the investigator or until unacceptable toxicity, symptomatic deterioration attributed to disease progression. There will be no dose reduction for Atezolizumab. Patients may temporarily suspend study treatment for up to 84 days beyond the scheduled date of delayed infusion if study drug-related toxicity requiring dose suspension is experienced. If Atezolizumab is held because of adverse events for greater than 84 days beyond the scheduled date of infusion, the patient will be discontinued from Atezolizumab and will be followed for safety and efficacy.

Primary Outcome Measure

Best Overall Response (BOR) [ Time Frame: Approximately 53.5 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
AdventHealth OrlandoOrlandoFlorida32804-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-

Find similar trials in Orlando, FL

By research site
AdventHealth Orlando· Orlando, FLUPMC Hillman Cancer Center· Pittsburgh, PA

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