A PHASE III, RANDOMIZED, DOUBLE-BLIND STUDY OF TIRAGOLUMAB PLUS ATEZOLIZUMAB COMPARED WITH PLACEBO PLUS ATEZOLIZUMAB IN PARTICIPANTS WITH COMPLETELY RESECTED STAGE IIB, IIIA, OR SELECT?IIIB, PD-L1 POSITIVE, NON?SMALL CELL LUNG CANCER WHO HAVE RECEIVED ADJUVANT PLATINUM-BASED CHEMOTHERAPY

Phase 3

• Conditions: C34 Malignant neoplasm of bronchus and lung; Malignant neoplasm of bronchus and lung

• Registration Number: PER-055-23
• Lead Sponsor: F. HOFFMANN-LA ROCHE LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-18
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Without startig enrollment
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

Signed Informed Consent Form.

Age >/= 18 years at the time of signing Informed Consent Form.

Eastern Cooperative Oncology Group performance status of 0 or 1.

Histological or cytological diagnosis of Stage IIB, IIIA, and select IIIB (T3N2) NSCLC of either non-squamous or squamous histology.

Participants must have had complete resection of NSCLC (no residual tumor and all surgical margins negative for invasive carcinoma).

At a minimum, mediastinal lymph node systematic sampling will have occurred, though complete mediastinal lymph node dissection (MLND) is preferred. Systematic sampling is defined as removal of at least one representative lymph node at specified stations. MLND entails resection of all lymph nodes at those same stations. Sampling or MLND at a minimum of 2 lymph node N2 stations is required.

Participants must have received between one to four cycles (four preferred) of adjuvant histology-based platinum doublet chemotherapy: cisplatin (preferred) or carboplatin, with pemetrexed (non-squamous), gemcitabine, docetaxel, vinorelbine, etoposide, or paclitaxel. Refer to NCCN/ESMO guidelines for acceptable adjuvant chemotherapy regimens.

Participants must have recovered adequately from surgery and from adjuvant chemotherapy (no Grade > 2 unresolved toxicity).

Patients must begin adjuvant chemotherapy within 12 weeks of their surgery date.

Patients must be randomized no more than 70 days (10 weeks) from last dose of chemotherapy (Day 1 of last cycle)

Tumor PD-L1 expression with a >/= 1% TC as determined by the investigational VENTANA PD-L1 (SP263) CDx Assay, documented through central testing of a representative tumor tissue specimen.

Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to randomization

For participants receiving therapeutic anticoagulation: stable anticoagulant regimen.

Negative HIV test at screening.

Participants meeting one of the following criteria for hepatitis B virus (HBV).

For women of c

Exclusion Criteria

Active tuberculosis.

Major surgical procedure within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study treatment period.

Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.

Any history of prior NSCLC within the last 5 years.

Previous NSCLC must have been treated with surgery only.

Any evidence of residual disease or disease recurrence following surgical resection of NSCLC, or during or following adjuvant chemotherapy.

NSCLC known to have mutation in the EGFR gene or an ALK fusion oncogene.

Prior treatment with systemic therapy (e.g., chemotherapy or immunotherapy) for the treatment of NSCLC, with the exception of adjuvant platinum-based chemotherapy as outlined in the inclusion criteria.

Prior treatment with radiation therapy for NSCLC (including PORT), with the exception of localized symptom-directed radiation prior to surgical resection.

Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, granulomatosis with polyangiitis, Sjögren syndrome, Guillain-Barre syndrome, or multiple sclerosis.

Positive Epstein-Barr virus (EBV) viral capsid antigen IgM test at screening.

History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.

History of malignancy within 5 years prior to initiation of study tr

Study & Design

• Study Type: Interventional
• Study Design: Not specified