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
Key facts
- Where
- Budapest Viii, Budapest XII, Gyöngyös, Kecskemét, Pécs, Tatabánya és Torokbalint, MagyarországSee the 7 sites
- Phase
- 3. fázis
Where in Magyarország
- Clinic Of Pulmonology Semmelweis UniversityBudapest Viii, MagyarországNo longer taking part
- Koranyi National Institute For PulmonologyBudapest XII, MagyarországNo longer taking part
- Matrai GyogyintezetGyöngyös, MagyarországNo longer taking part
- Bacs-Kiskun Varmegyei OktatokorhazKecskemét, MagyarországNo longer taking part
- University of PecsPécs, MagyarországNo longer taking part
- Komarom-Esztergom Varmegyei Szent Borbala KorhazTatabánya, MagyarországNo longer taking part
- Toeroekbalinti TuedogyogyintezetTorokbalint, MagyarországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- F. Hoffmann-La Roche AG
- Trial code
- EU 2023-506696-10-00
- Record updated
- 2025. november 5.
- Original description
1. To evaluate the safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumabRead full original descriptionShow less
A Phase III, Randomized, Double-Blind Study of Tiragolumab Plus Atezolizumab Compared with Placebo Plus Atezolizumab in Participants with Completely Resected Stage IIB, IIIA, or Select IIIB, PD-L1 Positive, Non-Small Cell Lung Cancer who have received Adjuvant Platinum-Based Chemotherapy
1. To evaluate the safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab
Inclusion: Eastern Cooperative Oncology Group performance status of 0 or 1; Histological or cytological diagnosis of Stage IIB, IIIA, and select IIIB (T3N2) NSCLC of either non-squamous or squamous histology; Participants must have had complete resection of NSCLC (no residual tumor and all surgical margins negative for invasive carcinoma); At a minimum, mediastinal lymph node systematic sampling will have occurred, though complete mediastinal lymph node dissection (MLND) is preferred; 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; Participants must have recovered adequately from surgery and from adjuvant chemotherapy (no Grade > 2 unresolved toxicity).
Exclusion: Any history of prior NSCLC within the last 5 years; Previous NSCLC must have been treated with surgery only; 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; Any evidence of residual disease or disease recurrence following surgical resection of NSCLC, or during or following adjuvant chemotherapy; NSCLC with a mutation in the EGFR gene or an ALK fusion oncogene.