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
Interventions
Trade Name: TECNETRIQ®
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Atezolizumab
CAS Number: 1380723-44-3
Current Sponsor code: RO5541267
Concentration unit: mg mill
Sponsors
F. Hoffmann La-Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age >=18 years at time of signing the Informed Consent Form • Histologically or cytologically documented NSCLC with locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology • Whole-body positron emission tomography–computed tomography (PET-CT) scan (from the base of skull to mid-thighs) for the purposes of staging, performed prior and within 42 days of the first dose of cCRT • At least two prior cycles of platinum-based chemotherapy administered cCRT completed within 1 to 42 days prior to baseline (one cycle of cCRT is defined as 21 or 28 days) • The radiotherapy (RT) component in the cCRT must have been at a total radiation dose of 60 (±10%) gray (Gy) (54 Gy to 66 Gy), administered either as intensity-modulated radiotherapy (IMRT) or by 3D-conforming technique • No progression during or following platinum-based cCRT • Tumor Programmed Cell Death 1–Ligand 1 (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 sample, in either a previously obtained archival tumor tissue sample or a fresh tissue sample obtained from a biopsy collected prior to the first dose of cCRT • Submission of representative formalin-fixed, paraffin-embedded (FFPE) tumor specimens in blocks (preferred) or at least 10 unstained serial slides, along with an associated pathology report to a central laboratory for PD-L1 testing • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 • Life expectancy >=12 weeks • 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: • Any history of prior NSCLC and/or any history of prior treatment for NSCLC (patients must be newly diagnosed with unresectable Stage III disease) • NSCLC known to have a mutation in the epidermal growth factor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene • 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 definitive cCRT prior to baseline • Any Grade > 2 unresolved toxicity from previous cCRT • Grade = 2 pneumonitis from prior cCRT • Concurrent enrolment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study • Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer • Active or history of autoimmune disease or immune deficiency • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest CT scan • History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death • Severe infection within 4 weeks prior to initiation of study treatment • Treatment with therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to initiation of study treatment • Prior allogeneic stem cell or solid organ transplantation • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications • Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during study treatment or within 5 months after the final dose of study treatment • Current treatment with anti-viral therapy for HBV or HCV • Treatment with investigational therapy within 28 days prior to initiation of study treatment • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte–associated protein 4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies • Treatment with systemic immunostimulatory agents (including, but not limited to, IFN and IL-2) within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment • Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor–?? [anti-TNF–?? agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of atezolizumab in patients with locally advanced unresectable Stage III NSCLC who have not progressed after at least two cycles of platinum-based concurrent chemoradiation therapy (cCRT) based on 12-month progression-free survival (PFS) rate.;Secondary Objective: • To evaluate the efficacy of atezolizumab in patients with locally advanced unresectable Stage III NSCLC who have not progressed after at least two cycles of platinum-based cCRT based on independent Review Facility (IRF) and investigator-assessed PFS, overall survival (OS), confirmed objective response rate (ORR), duration of response (DOR), PFS rate, OS rate, and time to death or distant metastasis (TTDM) • To evaluate the safety of atezolizumab in patients with locally advanced unresectable Stage III NSCLC who have not progressed after platinum-based cCRT. ;Primary end point(s): 12-month PFS rate, defined as the proportion of patients who have not experienced disease progression, as determined by an IRF according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), or death from any cause, at 12 months.;Timepoint(s) of evaluation of this end point: At 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. IRF-assessed PFS, defined as the time from initiation of study treatment to the first occurrence of disease progression, as determined by the IRF according to RECIST v1.1, or death from any cause, whichever occurs first 2. Investigator-assessed PFS, defined as the time from initiation of study treatment to the first occurrence of disease progression, as determined by the Investigator according to RECIST v1.1, or death from any cause, whichever occurs first 3. OS, defined as the time from initiation of study treatment to death from any cause 4. Confirmed ORR, defined as the proportion of patients with a confirmed objective response (i.e., complete response [CR] or partial response [PR] on two consecutive occasions = 4 weeks apart), as determined by the IRF and investigator according to RECIST v1.1 5. DOR, in patients with confirmed ORR, defined as the time from the first occurrence of a documented objective response to disease progression as determined by the IRF and investigator according to RECIST v1.1 or death from any cause, whichever occurs first 6. PFS rate at 18 months and 24 months, defined as the proportion of patients who have not experienced disease progression, as determined by the IRF and investigator according to RECIST v1.1, or death from any cause at 18 months and 24 months, respectively 7. OS rate at 12 months, 24 months and 36 months, defined as the proportion of patients who have not died from any cause at 12 months, 24 months and 36 months, respectively 8. TTDM, defined as the time from initiation of study treatment until the first date of distant metastasis or death in the absence of distant metastasis 9. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).;Timepoint(s) of evaluation of this end point: 1-2. From initiation of study treatment to the first occurrence of disease pr | — |
Countries
Brazil, Chile, China, Costa Rica, Kuwait, Romania, Saudi Arabia, Slovakia, Slovenia, Spain, Turkey, Viet Nam
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd
Outcome results
None listed