Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Atezolizumab

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

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.

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.

Liza Villaruz, MD

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.

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

PD-L1 protein expression will be measured as positive (present) or negative (absent) in tissue from a biopsy conducted after discontinuation of the prior therapy and before initiation of study drug.

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.

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.

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.

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.

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.

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.

The length of time from start of treatment that patients remain still alive.

The number of participants alive at 6 months.

The number of patients alive at 12 months.

The number of patients alive at 24 months.

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.

Genentech, Inc.

Assistant Professor of Medicine

CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2

Patients with Complete Response (CR) or Partial Response (PR) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min

CR/PR Cohort

Patients with Stable Disease (SD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min

SD Cohort

Patients with Progressive Disease (PD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min

PD Cohort

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Histology

Patients with advanced non-small cell lung cancer (NSCLC) patients previously treated with PD-1-directed therapy, treated with atezolizumab.

Barbara M Stadterman, Regulatory Supervisor, Clinical Research Services

Progressive Disease

Partial Response

Stable Disease

Unknown

Patients treated with atezolizumab who were previously treated with anti-PD-1 therapy and had at least one scan for evaluation of radiologic response.

Best Overall Response (BOR)

Patients treated with atezolizumab who were previously treated with anti-PD-1 therapy and evaluated for radiologic response.

Duration of Response (DOR)

Progression-free Survival (PFS)

6-month Progression-free Survival (PFS)

12-month Progression-free Survival (PFS)

Patients with Complete Response (CR) or Partial Response(PR) Atezolizumab was given on Day1 of a 21-day cycle at 1200 mg IV over60 (plus or minus15) minutes for first infusion, or decreased to 30+/-10 min

24-month Progression-free Survival (PFS)

Overall Survival (OS)

6-month Overall Survival (OS)

12-month Overall Survival (OS)

24-month Overall Survival (OS)

Diarrhea

Fatigue

Infusion related reaction

Lipase increased

Serum amylase increased

Generalized muscle weakness

Patients treated with atezolizumab who were previously treated with anti-PD-1 therapy.

Adverse Events ≥ Grade 3

PD-L1 Expression

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

Spots Global Cancer Trial Database for Evaluating the Efficacy of Atezolizumab in Advanced Non-small Cell Lung Cancer (NSCLC)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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