Long-term Safety & Efficacy Study of Atezolizumab in 2L NSCLC subpopulations

PHRR171027-001717

MO39171

2017-CT0422

A Phase III/IV, Single Arm, Multicenter Study Of Atezolizumab (Tecentriq) To Investigate Long-Term Safety And Efficacy In Previously-Treated Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer (TAIL)

Study MO39171 is a phase III/IV, single-arm, multicenter study of the long-term safety and efficacy of atezolizumab treatment in patients with Stage IIIb or Stage IV NSCLC who have progressed following standard systemic chemotherapy (including if given in combination with anti-PD-1 therapy or after anti-PD-1 as monotherapy).  Patients with a previously detected EGFR mutation or ALK fusion oncogene must have received targeted therapy followed by one line of standard systemic chemotherapy prior to receiving atezolizumab.  Overall, patients should not have received more than two lines of systemic chemotherapy.  Patients will also be eligible if they discontinued first-line or second-line therapy due to intolerance.

The study will consist of a Screening Period , a Treatment Period, a Treatment Discontinuation Visit occurring ≤ 30 days after the last dose of study medication, and a Follow-Up Period.  Day 1 (baseline) will be defined as the first day the patient receives atezolizumab.  It is anticipated that the trial will enroll 600 patients at 140 sites globally.

Ongoing

Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

·   Incidence of serious adverse events  related to atezolizumab treatment

·   Incidence of serious and non-serious immune-related adverse events related to atezolizumab treatment

Unspecified

Completed

• Algeria
• Argentina
• Brazil
• Colombia
• Costa Rica
• Denmark
• Egypt
• Greece
• Guatemala
• Italy
• Latvia
• Lebanon
• Malaysia
• Mexico
• Morocco
• Netherlands
• Panama
• Peru
• Philippines
• Poland
• Slovenia
• Spain
• Sweden
• United Arab Emirates
• United Kingdom

Clinical Trial

2017-CT0422

2017-10-09

0000-00-00

10

10

Unspecified

19 Jan 2018

Key inclusion criteria

·       Age ≥ 18 years

·       Patients with stage IIIb or IV NSCLC that has progressed following standard systemic chemotherapy (including if given in combination with anti-PD-1 therapy or after anti-PD-1 as monotherapy)

·       Patients with a previously detected EGFR mutation or ALK fusion oncogene must have received targeted therapy followed by one line of standard systemic chemotherapy prior to receiving atezolizumab

·       Overall, patients should not have received more than two lines of systemic chemotherapy

·       Patients with asymptomatic CNS metastases (treated or untreated)

·       ECOG performance status 0, 1, or 2

·       Life expectancy ≥ 12 weeks

·       Adequate hematologic and end-organ function

Key exclusion criteria

·       Symptomatic CNS metastases

·       Spinal cord compression  and leptomeningeal disease

·       Uncontrolled pericardial effusion, or ascites requiring recurrent drainage procedures

·       Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to study treatment initiation (incl. atezolizumab treatment in 1L)

·       History of autoimmune disease are allowed if controlled and on stable treatment (i.e., same treatment, same dose) for the last 12 weeks, with the exceptions with the exception of:

o   Patients taking concurrent abatacept or belatacept treatment, unless therapy has been withdrawn for > 8 weeks

o   Patients with a history of serious or life threatening immune-related events

o   No more than 1 concomitant autoimmune disease at the time of study entry is allowed unless one of them is:

>Autoimmune-mediated hypothyroidism on a stable dose of thyroid replacement hormone

>Controlled Type I diabetes mellitus on a stable dose of insulin regimen

>A medical history of such entities as atopic disease or childhood arthralgias, where the clinical suspicion of autoimmune disease is low.  In addition, transient autoimmune manifestations of an acute infectious disease that resolved upon treatment of the infectious agent are not excluded (e.g., acute Lyme arthritis)

Interventional

Atezolizumab

The dose of atezolizumab in this study will be 1200 mg administered by intravenous infusion every 3 weeks.  

None

Unspecified

Open Label

Unspecified

Unspecified

The primary objective of this study is to assess the long-term safety profile of atezolizumab in a noncomparative fashion. 

Phase III