A Study of Atezolizumab to investigate long term safety and efficacy in patients with locally advanced or metastatic non small cell lung cancer (NSCLC)

• Register: EUCTR
• Last refreshed on: 16 May 2022
• Main ID: EUCTR2017-001409-34-SI
• Date of registration: 22/08/2017
• Prospective Registration: Yes
• Primary sponsor: F. Hoffman-La Roche Ltd.
• Public title: A Study of Atezolizumab to investigate long term safety and efficacy in patients with locally advanced or metastatic non small cell lung cancer (NSCLC)
• Scientific title: 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)
• Date of first enrolment: 20/11/2017
• Target sample size: 600
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-001409-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: long-term safety & efficacy study of atezolizumab treatment in patients with Stage IIIb or IV NSCLC If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: F.Hoffmann-La Roche Ltd.

• Name: Trial Information Support Line-TISL
• Affiliation: F.Hoffmann-La Roche Ltd.

Key inclusion & exclusion criteria

Inclusion criteria:
-Signed Informed Consent Form
- Age = 18 years
- Able to comply with the study protocol, in the investigator's judgment
- Histologically or cytologically documented Stage IIIb or Stage IV NSCLC that has progressed following standard systemic chemotherapy (including if given in combination with anti-PD-1 therapy after anti-PD-1 as monotherapy, or after TKI therapy). Patients with a previously detected sensitizing EGFR mutation or ALK fusion oncogene must have received targeted therapy(TKI), followed by at least one line of standard systemic chemotherapy, prior to receiving atezolizumab. Overall, patients should not have received more than two lines of standard systemic chemotherapy. Patients who have discontinued first-line or second-line therapy due to intolerance are also eligible.
–Staging must be according to the UICC/AJCC system, 7th edition (Detterbeck et al. 2009) (see Appendix 8)
–Pathological characterization may be conducted on tumor specimens from earlier stage disease, but the tumor samples must be sufficient to distinguish squamous or non-squamous histology–Chemotherapy regimens will be counted based on interval disease progression, and not on the number of agents or the number of switches in agents (e.g., a first-line or second-line therapy that consists of several cycles of a platinum doublet and subsequent maintenance therapy that introduces or switches to a new chemotherapy agent without interval disease progression will all be considered one chemotherapy regimen)
–Patients with a previously-detected sensitizing EGFR mutation must have experienced disease progression (during or after treatment) on an EGFR TKI (erlotinib, gefitinib, osimertinib, etc.)
–Patients with a previously detected ALK fusion oncogene must have experienced disease progression (during or after treatment) with crizotinib, alectinib, or another ALK inhibitor
–Prior radiation therapy is allowed, provided that the patient has recovered from any toxic effects thereof. Combined radiation/chemotherapy treatment constitutes a single regimen
–Combined radiation/chemotherapy treatment (chemoradiation) counts as one prior chemotherapy regimen if < 6 months have elapsed between the last dose and the date of recurrence
–Adjuvant/neoadjuvant chemotherapy is not counted as a line of treatment
–Debulking surgery and anticancer agents used for pleurodesis are not counted as lines of therapy
- The last dose of prior systemic anticancer therapy or targeted therapy must have been administered = 21 days prior to randomization.
- Measurable disease, as defined by Response Evaluation Criteria for Solid Tumors, Version 1.1 (RECIST v1.1)
- Patients with asymptomatic CNS metastases (treated or untreated), as determined by CT or MRI evaluation during screening and prior radiographic evaluation, are eligible
- ECOG performance status 0, 1, or 2 [Appendix 7]
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab
–A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus)
–Examples of contraceptive methods with a failure rat
Exclusion criteria:
- Symptomatic CNS metastases
- Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for = 2 weeks prior to randomization
- Leptomeningeal disease
- Uncontrolled pericardial effusion or ascites requiring recurrent drainage procedures
- Pregnant or lactating, or intending to become pregnant during the study
–Women who are not postmenopausal (postmenopausal defined as = 12 months of non-drug-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 2 weeks prior to initiation of study drug
- Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome)
- Significant cardiovascular disease, such as New York Heart Association cardiac disease = Class III, myocardial infarction within 3 months, unstable arrhythmias, or unstable angina
–Patients with known coronary artery disease or left ventricular ejection fraction < 50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate
- Major surgical procedure within 4 weeks prior to study treatment initiation or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
- History of autoimmune disease (Appendix 5) are allowed if controlled and on stable treatment (i.e., same treatment, same dose) for the last 12 weeks, with the exception of:
- Patients taking concurrent abatacept or belatacept treatment, unless therapy has been withdrawn for > 8 weeks
–Patients with a history of serious or life threatening immune-related events
–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)
- Treatment with systemic immunostimulatory agents (including, but not limited to, interferons or interleukin-2) within 4 weeks or five half-lives of the drug, whichever is longer, prior to initiation of study treatment
–Prior cancer vaccines and cellular immunotherapy are permitted
- Specifically for patients without autoimmune disease: treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 2 weeks prior to study treatment initiation, or anticipated requirement for systemic immunosuppressive medications during the trial
–For patients with CNS metastases, use of prednisone at a stable dose (or dose equivalent) of = 20 mg/day is acceptable
–Chronic use of prednisone or equivalent should be discussed with the Medical Monitor
–The use of inhaled corticosteroids for chronic obstructive pulmonary disease,

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Malignant neoplasm of bronchus and lung (nsc) adv.
MedDRA version: 20.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: Atezolizumab
Product Code: RO5541267/F03
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: ATEZOLIZUMAB
CAS Number: 1380723-44-3
Current Sponsor code: RO5541267
Other descriptive name: MPDL3280A, Tecentriq
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 60-

Trade Name: Tecentriq
Product Name: Atezolizumab
Product Code: RO5541267/F03
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: ATEZOLIZUMAB
CAS Number: 1380723-44-3
Current Sponsor code: RO5541267
Other descriptive name: MPDL3280A, Tecentriq
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 60-

Primary Outcome(s)

Main Objective: -To evaluate the long-term safety of atezolizumab in previously treated patients with advanced NSCLC

Primary end point(s): •Incidence of serious adverse events (SAEs) related to atezolizumab treatment
•Incidence of immune-related adverse events (irAEs) related to atezolizumab treatment.

Secondary Objective: - To evaluate the efficacy of atezolizumab in previously treated patients with advanced NSCLC
- To further evaluate the efficacy of atezolizumab in previously treated patients with advanced NSCLC
- To further evaluate the long-term safety and efficacy of atezolizumab in previously treated patients with advanced NSCLC

Timepoint(s) of evaluation of this end point: At the end of the study. The end of study and final analysis will occur when all enrolled patients have either died, withdrawn consent, are lost to follow up, or have been followed for 30 months since the last study patient is enrolled, whichever occurs first.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: At the end of the study. The end of study and final analysis will occur when all enrolled patients have either died, withdrawn consent, are lost to follow up, or have been followed for 30 months since the last study patient is enrolled, whichever occurs first.

Secondary end point(s): •Overall survival (OS) rate at 2 years, defined as the proportion of patients remaining alive 2 years after initiation of study treatment
• OS, defined as the time from initiation of study treatment to death from any cause
• Progression-free survival (PFS), defined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first. PFS will be calculated based on disease status evaluated by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) and also by disease status evaluated by the investigator according to modified RECIST
• OS rate at 3 years, defined as the proportion of patients remaining alive 3 years after initiation of study treatment
• Objective response rate (ORR), defined as the percentage of patients who attain complete response (CR) or partial response (PR) according to RECIST v1.1 and also by disease status evaluated by the investigator according to modified RECIST
• Duration of response (DOR), defined as the time from initial response to disease progression or death among patients who have experienced a CR or PR (unconfirmed) during the study. Duration of response will be calculated based on disease status evaluated by the investigator according to RECIST v1.1 and also by disease status evaluated by the investigator according to modified RECIST

Secondary ID(s)

MO39171

Source(s) of Monetary Support

F. Hoffmann-La Roche Ltd.

Ethics review

Status: Approved
Approval date: 14/11/2017
Contact: