A 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.

Phase 1

• Conditions: on-Small Cell Lung Cancer.; MedDRA version: 21.1Level: PTClassification code 10029518Term: Non-small cell lung cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10029520Term: Non-small cell lung cancer stage IIIASystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-002853-11-NL
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-23
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 82

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;
• 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 27
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

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;
• 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 clinical trial of medicinal product
• Study Design: Not specified