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)
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
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.
AdventHealth Orlando
Orlando, Florida, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Best Overall Response (BOR)
Best response recorded is recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Per RECIST v1.1: Complete Response (CR) - Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: Approximately 53.5 months
Duration of Response (DOR)
The length of time that a tumor continues to respond to treatment from first documentation of response until disease progression.Per RECISIt v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Time frame: Approximately 56.5 months
Progression-free Survival (PFS)
The length of time during and after treatment that a patient lives with disease but without disease progression. Per RECISIT v1.1: Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Time frame: Approximately 56.5 months
6-month Progression-free Survival (PFS)
The number of patients alive without disease progression at 6 months, per RECIST v1.1. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Time frame: Up to 6 months
12-month Progression-free Survival (PFS)
The number of patients alive without disease progression at 12 months, per RECIST v1.1. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Time frame: Up to 12 months
24-month Progression-free Survival (PFS)
The number of patients alive without disease progression at 24 months, per RECIST v1.1. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Time frame: Up to 24 months
Overall Survival (OS)
The length of time from start of treatment that patients remain still alive.
Time frame: Approximately 56.5 months
6-month Overall Survival (OS)
The number of participants alive at 6 months.
Time frame: Up to 6 months
12-month Overall Survival (OS)
The number of patients alive at 12 months.
Time frame: Up to 12 months
24-month Overall Survival (OS)
The number of patients alive at 24 months.
Time frame: Up to 24 months
Adverse Events ≥ Grade 3
Number of patients that experienced grade 3 or greater Adverse events per the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 4, determined to be at least possibly, probably or definitely related to treatment, or that result in dose holds or reductions, will be collected and reported. Grade 3 = Severe AE and Grade 4 = Life-threatening or disabling AE. Adverse events and serious adverse events will be tabulated in order of prevalence, with the highest grade reported by each patient.
Time frame: Approximately 56.5 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.