Non-small cell lung cancer (NSCLC) MedDRA version: 21.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10079440 Term: Non-squamous non-small cell lung cancer 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: • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 • Histologically or cytologically documented locally advanced unresectable or metastatic non-squamous NSCLC • No prior systemic treatment for metastatic non-squamous NSCLC • Known tumor PD-L1 status • Measurable disease, as defined by RECIST v1.1 • Life expectancy >= 12 weeks • Adequate hematologic and end-organ function • Negative HIV test at screening • Serology test negative for active hepatitis B virus or active hepatitis C virus at screening 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: • Patients with NSCLC which harbors a mutation in the EGFR gene or an ALK fusion oncogene • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases • 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 peumonitis • History of malignancy other than NSCLC within 5 years prior to randomization, 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 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 within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment • Treatment with systemic immunosuppressive medication 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 tiragolumab in combination with atezolizumab plus pemetrexed and carboplatin/cisplatin (Arm A) compared with placebo in combination with pembrolizumab plus pemetrexed and carboplatin/cisplatin (Arm B) on the basis of confirmed objective response rate (ORR) and progression-free survival (PFS), as assessed by investigators according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).;Secondary Objective: • To evaluate the efficacy of tiragolumab in combination with atezolizumab plus pemetrexed and carboplatin/cisplatin (Arm A) compared with placebo in combination with pembrolizumab plus pemetrexed and carboplatin/cisplatin (Arm B) on the basis of overall survival, duration of response and time to confirmed deterioration in patient-reported physical functioning and global health status/quality of life (GHS/QoL), and in patient-reported lung cancer symptoms for cough, dyspnea (a multi-item subscale), and chest pain • To evaluate the safety of tiragolumab in combination with atezolizumab plus pemetrexed and carboplatin/cisplatin (Arm A) compared with placebo in combination with pembrolizumab plus pemetrexed and carboplatin/cisplatin (Arm B) • To characterize the pharmacokinetics of tiragolumab and atezolizumab • To evaluate the immune response to tiragolumab and atezolizumab.;Primary end point(s): 1. Investigator-Assessed Confirmed Objective Response Rate (ORR) 2. Investigator-Assessed Progression-free survival (PFS).;Timepoint(s) of evaluation of this end point: 1-2. Up to 5 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Overall survival 2. Duration of response for patients with a confirmed objective response, defined as the time from first occurrence of a confirmed objective response to disease progression or death from any cause (whichever occurs first) 3. Time to confirmed deterioration (TTCD) in patient-reported physical functioning and global health status/quality of life (GHS/QoL), as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core (QLQ-C30), and in patient-reported lung cancer symptoms for cough, dyspnea (a multi-item subscale), and chest pain, as measured through the use of the EORTC Quality-of-Life Questionnaire Lung Cancer Module (QLQ-LC13) 4. Percentage of Participants with Adverse Events (AEs) 5. Frequency of patients’ response of the degree they are troubled with treatment symptoms, as assessed through use of the single-item EORTC IL46 6. Serum concentrations of tiragolumab and atezolizumab 7. Percentage of participants with anti-drug antibodies (ADAs) to tiragolumab 8. Percentage of participants with ADAs to atezolizumab.;Timepoint(s) of evaluation of this end point: 1-5. Up to 5 years 6-8. Day 1 of Cycle 1, 2, 3, 4, 8, 12, 16 and at treatment discontinuation (up to 5 years). | — |
Countries
Belgium, Canada, Denmark, France, Germany, Hong Kong, Italy, Korea, Republic of, New Zealand, Spain, Switzerland, Taiwan, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
Genentech Inc. c/o F. Hoffmann-La Roche Ltd
Outcome results
None listed