Trial purpose
Cancer treatment
Tumor type
Lung cancer
Age
18+
Clinical summary
Summary
Eligible participants will be assigned to one of two experimental cohorts. Experimental Cohort A will recruit participants with high programmed death-ligand 1 (PD-L1) expressing cancer, and they will receive neoadjuvant atezolizumab plus tiragolumab for 4 cycles, followed by surgical removal of the cancer and either adjuvant atezolizumab plus tiragolumab for 16 cycles or adjuvant chemotherapy for 4 cycles at the discretion of the investigator. Experimental Cohort B will recruit participants with any PD-L1 expression level and they will receive neoadjuvant atezolizumab plus tiragolumab plus chemotherapy for 4 cycles, followed by surgical resection and adjuvant atezolizumab plus tiragolumab for 16 cycles. Atezolizumab (1200mg) will be administered via intravenous (IV) infusion on Day 1 of each 21-day cycle. Tiragolumab (600mg) will be administered by IV infusion on Day 1 of each 21-day cycle. Chemotherapy may include: cisplatin/carboplatin + pemetrexed (for non-squamous only), cisplatin/carboplatin + gemcitabine (for squamous only), or carboplatin + paclitaxel.
Conditions
This trial is treating people with non-small cell lung cancer
Eligibility
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
- 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, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- Active tuberculosis
- Significant cardiovascular disease
- 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 negligible risk of metastasis or death
- 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
- Pregnancy or breastfeeding
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Hoffmann-La Roche
Scientific Title
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
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