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.
- Conditions
- lung cancerNon-small cell lung cancer1003866610029107
- Registration Number
- NL-OMON51422
- Lead Sponsor
- Roche Nederland B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 9
• 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, as
confirmed by the operating attending surgeon and involved medical oncologist
prior to study enrollment;
• Adequate pulmonary function to be eligible for surgical resection;
• Measurable disease, as assessed by the investigator per RECIST v1.1;
• Adequate tumor tissue for PD-L1 assessment;
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
• Adequate hematologic and end-organ function;
• Negative HIV test at screening;
• Negative for active hepatitis B and hepatitis C at screening.
• NSCLC with histology of large cell neuroendocrine carcinoma, sarcomatoid
carcinoma, or NSCLC not otherwise specified;
• Small cell lung cancer (SCLC) histology or NSCLC with any component of SCLC;
• Any prior therapy for lung 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;
• NSCLC with an activating EGFR mutation or ALK fusion oncogene;
• Known c-ros oncogene 1 (ROS1) rearrangement;
• 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 investigational therapy within 42 days prior to initiation of
study treatment;
• Prior treatment with CD137 agonists or immune checkpoint blockade therapies,
including anti-CTLA-4, anti-PD-1, anti-TIGIT, and anti-PD-L1 therapeutic
antibodies;
• Pregnant or lactating women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety:<br /><br>- To evaluate the safety of Atezo + Tira as neoadjuvant treatment followed by<br /><br>either Atezo + Tira or Chemo as adjuvant treatment<br /><br>- To evaluate the safety of Atezo + Tira + Chemo as neoadjuvant treatment<br /><br>followed by Atezo + Tira as adjuvant treatment.<br /><br><br /><br>Primary Efficacy<br /><br>- To evaluate the efficacy of Atezo + Tira or Atezo + Tira + Chemo as<br /><br>neoadjuvant treatment</p><br>
- Secondary Outcome Measures
Name Time Method <p>Efficacy<br /><br>- To evaluate the efficacy of Atezo + Tira or Atezo + Tira + Chemo as<br /><br>neoadjuvant treatment<br /><br>- To evaluate the efficacy of Atezo + Tira as neoadjuvant treatment followed by<br /><br>either Atezo + Tira or Chemo as adjuvant treatment<br /><br>- To evaluate the efficacy of Atezo + Tira + Chemo as neoadjuvant treatment<br /><br>followed by Atezo + Tira as adjuvant treatment</p><br>