A Study Evaluating the Safety and Efficacy of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab, With or Without Platinum-Based Chemotherapy, in Participants With Previously Untreated Locally Advanced Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer
Megadott ok: Study was terminated as data became available from Phase 3 trials of perioperative regimens combining chemotherapy with immunotherapy showing improved efficacy outcomes versus chemotherapy alone.
Key facts
- Where
- A Coruña, Barcelona, L'Hospitalet de Llobregat, Madrid, Majadahonda és Sabadell, SpanyolországSee the 6 sites
- Phase
- 2. fázis
Where in Spanyolország
- Complejo Hospitalario Universitario A Coruña (CHUAC)A Coruña, SpanyolországNo longer taking part
- Vall d?Hebron Institute of Oncology (VHIO), BarcelonaBarcelona, SpanyolországNo longer taking part
- ICO l'HospitaletL'Hospitalet de Llobregat, SpanyolországNo longer taking part
- Hospital Universitario 12 de OctubreMadrid, SpanyolországNo longer taking part
- Hospital Universitario Puerta de HierroMajadahonda, SpanyolországNo longer taking part
- Corporacio Sanitaria Parc TauliSabadell, SpanyolországNo longer taking part
Trial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT04832854
- Record updated
- 2026. március 11.
- Original description
This study will evaluate the surgical safety and feasibility of atezolizumab plus tiragolumab alone or in combination with platinum-based chemotherapy as neoadjuvant treatment for participants with previously untreated locally advanced non-small cell lung cancer (NSCLC). The study will also evaluate the efficacy, pharmacokinetics, immunogenicity, and safety of atezolizumab plus tiragolumab alone or in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by adjuvant atezolizumab plus tiragolumab or adjuvant platinum-based chemotherapy.Read full original descriptionShow less
A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab, With or Without Platinum-Based Chemotherapy, in Patients With Previously Untreated Locally Advanced Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer
This study will evaluate the surgical safety and feasibility of atezolizumab plus tiragolumab alone or in combination with platinum-based chemotherapy as neoadjuvant treatment for participants with previously untreated locally advanced non-small cell lung cancer (NSCLC). The study will also evaluate the efficacy, pharmacokinetics, immunogenicity, and safety of atezolizumab plus tiragolumab alone or in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by adjuvant atezolizumab plus tiragolumab or adjuvant platinum-based chemotherapy.
Inclusion: Histologically or cytologically confirmed Stage II, IIIA, or select IIIB (T3N2 only) NSCLC of squamous or non-squamous histology; Eligible for R0 resection with curative intent at the time of screening; Adequate pulmonary function to be eligible for surgical resection with curative intent; Eligible to receive a platinum-based chemotherapy regimen; Measurable disease, as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; Availability of a representative tumor specimen that is suitable for determination of PD-L1 status; Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; Normal life expectancy, excluding lung cancer mortality risk; Adequate hematologic and end-organ function; Negative human immunodeficiency virus (HIV) test at screening; Negative serology for active hepatitis B virus (HBV) and active hepatitis C virus (HCV) at screening.
Exclusion: Any prior therapy for lung cancer; Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety; Prior treatment with CD127 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, anti-TIGIT, and anti-PD-L1 therapeutic antibodies; Treatment with systemic immunostimulatory agents; Treatment with systemic immunosuppressive medication; Small cell lung cancer (SCLC) histology or NSCLC with any component of SCLC; Active or history of autoimmune disease or immune deficiency; History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan; Active tuberculosis; Significant cardiovascular disease; History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with negligible risk of metastasis or death; NSCLC with an activating EGFR mutation or ALK fusion oncogene; NSCLC with histology of large cell neuroendocrine carcinoma, sarcomatoid carcinoma, or NSCLC not otherwise specified; Known c-ros oncogene 1 (ROS1) rearrangement; Pregnancy or breastfeeding.