Non-small cell lung cancer (NSCLC) MedDRA version: 21.1 Level: PT Classification code 10029519 Term: Non-small cell lung cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age>= 18 years - Eastern Cooperative Oncology Group Performance Status of 0 or 1 - Histologically or cytologically documented NSCLC with locally advanced unresectable Stage III NSCLC of either squamous or nonsquamous histology - Whole-body positron emission tomography (PET)-CT scan for the purposes of staging, performed prior and within 42 days of the first dose of concurrent chemoradiotherapy (CRT) - At least two prior cycles of platinum-based chemotherapy concurrent with RT (cCRT), which must be completed within 1 to 42 days prior to randomization in the study (one cycle of cCRT is defined as 21 or 28 days) - The RT component in the cCRT must have been at a total dose of radiation of 60 Gy±10% (54 Gy to 66 Gy) administered by intensitymodulated radiotherapy (preferred) or 3D-conforming technique - No progression during or following concurrent platinum-based CRT - Tumor PD-L1 expression, as determined by the investigational Ventana PD-L1 (SP263) CDx assay and documented by means of central testing of a representative tumor tissue, in either a previously obtained archival tumor tissue or fresh tissue obtained from a biopsy collected prior to the first dose of cCRT - Adequate hematologic and end-organ function. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 170 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 138
Exclusion criteria
Exclusion criteria: - Any history of prior NSCLC - NSCLC known to have a mutation in the epidermal growth factor mutation and/or an anaplastic lymphoma kinase translocation - Any evidence of Stage IV disease - Treatment with sequential CRT for locally advanced NSCLC - Patients with locally advanced NSCLC who have progressed during or after the definitive concurrent CRT prior to randomization - Any Grade > 2 unresolved toxicity from previous CRT - Grade >=2 pneumonitis from prior CRT - Active or history of autoimmune disease or immune deficiency, history of idiopathic pulmonary fibrosis, organizing pneumonia - History of malignancy other than NSCLC within 5 years prior to screening - Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in the opinion of the investigator, could impact patient safety - Prior allogeneic stem cell or solid organ transplantation - Active Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection at screening - Treatment with investigational therapy within 28 days prior to initiation of study treatment - Prior treatment with CD137 agonists or immune checkpoint blockade therapies - Any prior Grade >= 3 immune-mediated adverse event or any unresolved Grade > 1 immune-mediated adverse event while receiving any previous immunotherapy agent other than immune checkpoint blockade agents - Current treatment with anti-viral therapy for hepatitis B virus or hepatitis C virus - Active EBV infection or known or suspected chronic active EBV infection at Screening - Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated protein 4, anti-T-cell immunoreceptor with Ig and ITIM domains, anti-PD-1, and anti-PD-L1 therapeutic antibodies - Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor-[antiTNF-alpha]agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressivemedication during study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the efficacy of atezolizumab in combination with tiragolumab compared with durvalumab in the intent to treat (ITT) and the programmed death-ligand 1 (PD-L1)-positive populations based on an independent review facility-assessed progression-free survival.;Secondary Objective: • To evaluate the efficacy of atezolizumab plus tiragolumab compared with durvalumab in the ITT and the PD-L1-positive populations based on OS after randomization, Investigator -assessed progression-free survival, , time to death or distant metastasis, confirmed objective response rate, duration of response in patients with confirmed objective response rate, progression-free survival rate, OS rate, time to confirmed deterioration • To evaluate the safety and tolerability of tiragolumab plus atezolizumab compared with placebo plus durvalumab • To characterize pharmacokinetics of tiragolumab and atezolizumab • To evaluate the immune response to tiragolumab plus atezolizumab.;Primary end point(s): 1. Independent review facility-assessed Progression Free Survival in ITT and PD-L1 positive populations.;Timepoint(s) of evaluation of this end point: 1. Up to 90 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Overall survival 2. Investigator -assessed Progression Free Survival 3. Time to death or distant metastasis 4. Confirmed Objective response rate 5. Duration of Response in patients with confirmed ORR 6. Progression Free Survival rate at 12 months, 18 months, and 24 months 7. Overall Survival rate at 12 months, 24 months, 36 months, and 48 months 8. Time to confirmed deterioration 9. Incidence and severity of adverse events 10. Serum concentrations of tiragolumab and atezolizumab at specified timepoints 11. Prevalence and incidence of anti-drug antibodies (ADAs) to tiragolumab and atezolizumab at baseline and during the study.;Timepoint(s) of evaluation of this end point: 1-5. Up to 90 months 6. At 12 months, 18 months, and 24 months 7. At 12 months, 24 months, 36 months, and 48 months 8-9. Up to 90 months 10 and 11. Day 1 of Cycle 1-4,8,10,12 and at treatment discontinuation or completion visit; for tiragolumab: Day 1 of cycle 3. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Republic of, Netherlands, Poland, Portugal, Russian Federation, Spain, Taiwan, Thailand, Turkey, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
Genentech Inc. c/o F. Hoffmann-La Roche Ltd
Outcome results
None listed