NCT03014648

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

A Phase II Clinical Trial Evaluating the Efficacy of Atezolizumab in Advanced Non-small Cell Lung Cancer (NSCLC) in Patients Previously Treated With PD-1-directed Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Liza Villaruz, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

Atezolizumab will be given on day 1 of a 21-day cycle at 1200 mg IV. Radiographic assessments for disease response will occur every 6 weeks while on treatment. Confirmatory scans should be obtained ≥ 4 weeks following initial documentation of objective response or progressive disease on atezolizumab therapy. 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. Patients will be followed for 12 months or until death as per standard of care after discontinuation of Atezolizumab or until death, whichever occurs first.

Conditions

• Advanced Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Atezolizumab	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.

Timeline

• Start date: 2017-07-18
• Primary completion: 2021-12-31
• Completion: 2022-03-31
• First posted: 2017-01-09
• Last updated: 2023-12-13
• Results posted: 2023-12-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study