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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

Phase 1
Conditions
on-Small Cell Lung Cancer
MedDRA version: 21.1Level: PTClassification code: 10029520Term: Non-small cell lung cancer stage IIIA Class: 100000004864
MedDRA version: 21.1Level: PTClassification code: 10029518Term: Non-small cell lung cancer stage II Class: 100000004864
MedDRA version: 21.1Level: PTClassification code: 10029521Term: Non-small cell lung cancer stage IIIB Class: 100000004864
Therapeutic area: Diseases [C] - Neoplasms [C04]
Registration Number
CTIS2022-502978-17-00
Lead Sponsor
F. Hoffmann-La Roche AG
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
50
Inclusion Criteria

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, Availability of a representative tumor specimen that is suitable for determination of PD-L1 status via central testing, Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria

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 on screening chest CT scan, NSCLC with an activating EGFR mutation or ALK fusion oncogene

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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