A Study designed to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab administered in participants with PD-L1 = 1% TC Stage IIB, IIIA, or select IIIB (T3N2 only) NSCLC following resection and adjuvant platinum-based chemotherapy
- Conditions
- on-Small Cell Lung CancerMedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10029519Term: Non-small cell lung cancer stage III Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10029518Term: Non-small cell lung cancer stage II Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-506696-10-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1150
1. Eastern Cooperative Oncology Group performance status of 0 or 1, 2. Histological or cytological diagnosis of Stage IIB, IIIA, and select IIIB (T3N2) NSCLC of either non-squamous or squamous histology, 3. Participants must have had complete resection of NSCLC (no residual tumor and all surgical margins negative for invasive carcinoma), 4. At a minimum, mediastinal lymph node systematic sampling will have occurred, though complete mediastinal lymph node dissection (MLND) is preferred, 5. Participants must have received between one to four cycles (four preferred) of adjuvant histology-based platinum doublet chemotherapy: cisplatin (preferred) or carboplatin, with pemetrexed (non-squamous), gemcitabine, docetaxel, vinorelbine, etoposide, or paclitaxel, 6. Participants must have recovered adequately from surgery and from adjuvant chemotherapy (no Grade > 2 unresolved toxicity)
1. Any history of prior NSCLC within the last 5 years, 2. Previous NSCLC must have been treated with surgery only, 3. Any evidence of residual disease or disease recurrence following surgical resection of NSCLC, or during or following adjuvant chemotherapy, 4. NSCLC with a mutation in the EGFR gene or an ALK fusion oncogene, 5. Prior treatment with systemic therapy (e.g., chemotherapy or immunotherapy) for the treatment of NSCLC, with the exception of adjuvant platinum-based chemotherapy as outlined in the inclusion criteria
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1. To evaluate the efficacy of tiragolumab plus atezolizumab compared with placebo plus atezolizumab based on DFS in the PD-L1 = 50% TC and PD-L1 = 1% TC populations;Secondary Objective: 1. To evaluate the safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab, 2. To evaluate the efficacy of tiragolumab plus atezolizumab compared with placebo plus atezolizumab based on OS and 3-year, 5-year, and 7-year DFS rates, 3. To evaluate the health-related quality of life of participants treated with tiragolumab plus atezolizumab compared with placebo plus atezolizumab, 4. To characterize the PK of tiragolumab plus atezolizumab, 5. To evaluate the immune response to tiragolumab and atezolizumab;Primary end point(s): 1. Disease-Free Survival (DFS) in PD-L1 =1 % TC and PD-L1 = 50% TC
- Secondary Outcome Measures
Name Time Method Secondary end point(s):1. Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5.0;Secondary end point(s):2. Overall Survival;Secondary end point(s):3. 3-year, 5-year, and 7-year DFS rates;Secondary end point(s):4. Health-related quality of life on the basis of proportion of participants who maintain or meaningfully improve from baseline in patient-reported role, emotional, and physical functioning and GHS/QOL over the course of treatment.;Secondary end point(s):5. Serum concentration of tiragolumab at specified timepoints;Secondary end point(s):6. Serum concentration of atezolizumab at specified timepoints;Secondary end point(s):7. Prevalence of ADAs to tiragolumab at baseline and incidence of ADAs to tiragolumab during the study;Secondary end point(s):8. Prevalence of ADAs to atezolizumab at baseline and incidence of ADAs to atezolizumab during the study