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)

• Register: RPEC
• Last refreshed on: 4 September 2023
• Main ID: PER-029-17
• Date of registration: 18/01/2018
• Prospective Registration: Yes
• Primary sponsor: F. HOFFMANN-LA ROCHE LTD.,
• Public 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)
• 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: 27/02/2018
• Target sample size: 10
• Recruitment status: Complete
• URL: https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=029-17
• Study type: Interventional
• Study design: 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 one line of standard systemic chemotherapy (with or without an additional line of targeted therapy) or one line of anti-PD-1 therapy (with or without an additional line of standard systemic chemotherapy).
• Phase: III

Countries of recruitment

Argentina, Argeria, Brazil, China, Colombia, Costa Rica, Denmark, Egypt, Greece, Guatemala, Italy, Latovia, Lebano, Malasya, Mexico, Morocco, Norway, Panama, Peru, Philippines, Poland, Slovenia, Spain, Sweden, United Arab Emirates, United Kindgdom

Contacts

• Name: Leslie Peralta Kikushima
• Affiliation: ROCHE FARMA (PERU) S.A.

• Name: Sandra Paez Viale
• Affiliation: ROCHE FARMA (PERU) S.A.

Key inclusion & exclusion criteria

Inclusion criteria: Age ≥ 18 years, *Histologically or cytologically documented Stage IIIb or Stage IV NSCLC that: 1) has been treated with one line of standard systemic chemotherapy (with or without an additional line of targeted therapy) or one line of anti-PD-1 therapy (with or without an additional line of standard systemic chemotherapy), and 2) has recurred and is currently progressing. *ECOG performance status 0, 1, or 2 *Life expectancy ≥ 12 weeks. *Measurable disease, as defined by Response Evaluation Criteria for Solid Tumors, Version 1.1. *Patients with asymptomatic CNS metastases (treated or untreated), as determined by CT or MRI evaluation during screening and prior radiographic evaluation, are eligible.
Exclusion criteria:
1.Symptomatic CNS metastases. 2.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. 3.Leptomeningeal disease.4.Uncontrolled pericardial effusion or ascites requiring recurrent drainage procedures
5.Pregnant or lactating, or intending to become pregnant during the study. 6.Significant cardiovascular disease, such as New York Heart Association cardiac disease ≥ Class III, myocardial infarction within 3 months, unstable arrhythmias, or unstable angina. 7.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.


Age minimum:
Age maximum:
Gender: --

Health Condition(s) or Problem(s) studied

-C34 Malignant neoplasm of bronchus and lung
Malignant neoplasm of bronchus and lung

C34

Malignant neoplasm of bronchus and lung

Intervention(s)

Vial 1200 mg/20 ml. of atezolizumab solution, The dose of atezolizumab in this study will be 1200 mg administered by intravenous infusion every 3 weeks (21 [± 3] days).

Secondary ID(s)

2017-001409-34

Source(s) of Monetary Support

F. HOFFMANN-LA ROCHE LTD.

Ethics review

Status: Approved
Approval date: 15/08/2017
Contact:

[e-mail]

Via Libre

4331396

[e-mail]

Results

• Results available: Yes
• Date Completed: 05/06/2020