Phase III Randomized Double-Blind Trial of Tiragolumab and Atezolizumab Versus Placebo and Atezolizumab in Resected Stage IIB-IIIB PD-L1 Positive NSCLC

The primary objective of this Phase III, randomized, double-blind study is to evaluate the **safety** 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** (NSCLC) who have received adjuvant platinum-based chemotherapy. This evaluation is clinically relevant as it aims to determine the safety profile of the combination therapy, which could potentially offer a new therapeutic option for patients with this specific type of lung cancer. The study does not list any secondary objectives.

The clinical trial involves a total of **574 participants** diagnosed with **Non-Small Cell Lung Cancer** (NSCLC). The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, which typically represent adults and older adults. Participants were selected based on specific criteria, including an Eastern Cooperative Oncology Group performance status of 0 or 1, and a histological or cytological diagnosis of Stage IIB, IIIA, and select IIIB (T3N2) NSCLC. All participants have undergone complete resection of NSCLC with no residual tumor and negative surgical margins for invasive carcinoma. Additionally, they have received between one to four cycles of adjuvant histology-based platinum doublet chemotherapy and have adequately recovered from surgery and chemotherapy. The trial does not include a vulnerable population, and lifestyle factors such as diet and physical activity are not specified as part of the selection criteria.

The clinical trial is a **Phase III**, randomized, double-blind, controlled study designed to evaluate the efficacy and safety 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 (NSCLC) who have received adjuvant platinum-based chemotherapy. The trial aims to assess the safety profile of the investigational combination therapy, with the primary endpoint being the incidence and severity of adverse events, as determined by the NCI CTCAE v5.0. The trial is expected to commence recruitment on May 15, 2024, and is estimated to conclude by April 30, 2039.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as an Eastern Cooperative Oncology Group performance status of 0 or 1, a histological or cytological diagnosis of Stage IIB, IIIA, or select IIIB (T3N2) NSCLC, and complete resection of the tumor. Following the screening, participants will be randomized to receive either the investigational treatment or placebo. Regular follow-up visits will be scheduled to monitor the participants' health status, treatment adherence, and any adverse events. The end-of-study visit will mark the completion of the trial for each participant, where final assessments will be conducted.

The expected length of participant involvement in the trial is contingent upon the individual treatment response and the occurrence of any adverse events. Conditions that may lead to early termination from the study include the development of unacceptable toxicity, withdrawal of consent, or any other medical condition that, in the opinion of the investigator, warrants discontinuation. The trial is structured to ensure rigorous monitoring and adherence to ethical standards, with the safety and well-being of participants being of paramount importance throughout the study duration.

The clinical trial involves the administration of **tiragolumab**, an investigational medication developed by F. Hoffmann-La Roche Ltd. Tiragolumab is a protein-based therapeutic agent, classified under the category of "Protein - Other." The pharmaceutical form, dosage, route, and frequency of administration are not specified in the provided data. The medication is not a pediatric formulation and is not designated as an orphan drug. The trial aims to evaluate the safety and efficacy of tiragolumab in combination with 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.

**Atezolizumab**, another investigational product in the study, is developed by Roche Registration GmbH. It is also a protein-based therapeutic agent, with alternative descriptive names including MPDL3280A, Anti-PDL1, Anti-PD-L1, and aPDL1. The product is authorized under the marketing authorization number EU/1/17/1220/002 and is subject to secondary packaging and labeling for clinical trial use. The pharmaceutical form, dosage, route, and frequency of administration are not detailed in the provided data. Atezolizumab is not a pediatric formulation and is not designated as an orphan drug. The trial evaluates the combination of atezolizumab with tiragolumab or placebo to assess safety and efficacy in the specified patient population.

The study also includes a **placebo** comparator, which is used in combination with atezolizumab to serve as a control group. The placebo is not specified in terms of its pharmaceutical form, dosage, route, or frequency of administration. The inclusion of a placebo group allows for a double-blind study design, ensuring that neither the participants nor the investigators are aware of the treatment assignments, thereby reducing bias and enhancing the reliability of the trial results.

Efficacy in this clinical trial will be assessed by evaluating the primary endpoint, which is the incidence and severity of adverse events. The severity of these adverse events will be determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. This trial involves 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. The study is designed as a Phase III, randomized, double-blind trial comparing tiragolumab plus atezolizumab with placebo plus atezolizumab. The efficacy assessments will be conducted throughout the trial duration, with specific timepoints and methods for data collection and analysis not explicitly detailed in the provided information. The trial aims to provide confirmatory data on the safety and efficacy of the investigational treatment regimen.