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

Lead Sponsor: Hoffmann-La Roche

This study will evaluate the surgical safety and feasibility of atezolizumab plus tiragolumab alone or in combination with platinum-based chemotherapy as neoadjuvant treatment for participants with previously untreated locally advanced non-small cell lung cancer (NSCLC). The study will also evaluate the efficacy, pharmacokinetics, immunogenicity, and safety of atezolizumab plus tiragolumab alone or in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by adjuvant atezolizumab plus tiragolumab or adjuvant platinum-based chemotherapy.

• Non-Small Cell Lung Cancer (NSCLC)

Tipo di intervento: Drug

Nome intervento: Atezolizumab

Descrizione: Atezolizumab 1200 mg will be administered by intravenous (IV) infusion on Day 1 of each 21-day cycle.

Altro nome: Tecentriq

Tipo di intervento: Drug

Nome intervento: Tiragolumab

Descrizione: Tiragolumab 600 mg will be administered by IV infusion on Day 1 of each 21-day cycle.

Altro nome: MTIG7192A

Tipo di intervento: Drug

Nome intervento: Carboplatin

Descrizione: Carboplatin at initial target area under the concentration curve (AUC) of 5 or 6 mg/mL/min will be administered by IV infusion on Day 1 of each 21-day cycle.

Tipo di intervento: Drug

Nome intervento: Cisplatin

Descrizione: Cisplatin at 75 mg/m^2 will be administered by IV infusion on Day 1 of each 21-day cycle.

Tipo di intervento: Drug

Nome intervento: Pemetrexed

Descrizione: Pemetrexed at 500 mg/m^2 will be administered by IV infusion on Day 1 of each 21-day cycle.

Tipo di intervento: Drug

Nome intervento: Gemcitabine

Descrizione: Gemcitabine at 1000 or 1250 mg/m^2 will be administered by IV infusion on Days 1 and 8 of each 21-day cycle.

Tipo di intervento: Drug

Nome intervento: Paclitaxel

Descrizione: Paclitaxel at 175 or 200 mg/m^2 will be administered by IV infusion on Day 1 of each 21-day cycle.

Criteri:

Key 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 - 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 Key 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, 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

Genere: All

Età minima: 18 Years

Età massima: N/A

Volontari sani: No

Cognome: Reference Study ID Number: GO42501 www.roche.com/about_roche/roche_worldwide.htm

Telefono: 888-662-6728 (U.S. Only)

E-mail: [email protected]

Spain

Switzerland

United States

2021-04-01

Genere: Sponsor

• Lung Neoplasms
• Carcinoma, Non-Small-Cell Lung

Etichetta: Cohort A (PD-L1 High)

Genere: Experimental

Descrizione: Participants with high programmed death-ligand 1 (PD-L1) expression level will be enrolled in Cohort A and receive neoadjuvant atezolizumab plus tiragolumab for 4 cycles, followed by surgical resection and either adjuvant atezolizumab plus tiragolumab for 16 cycles or adjuvant chemotherapy for 4 cycles at the discretion of the investigator. Chemotherapy may include: cisplatin/carboplatin + pemetrexed (for non-squamous only) cisplatin/carboplatin + gemcitabine (for squamous only) carboplatin + paclitaxel

Etichetta: Cohort B (PD-L1 All Comers)

Genere: Experimental

Descrizione: All comers, which are participants with any PD-L1 expression level, will be enrolled in Cohort B and receive neoadjuvant atezolizumab plus tiragolumab plus chemotherapy for 4 cycles, followed by surgical resection and adjuvant atezolizumab plus tiragolumab for 16 cycles. Chemotherapy may include: cisplatin/carboplatin + pemetrexed (for non-squamous only) cisplatin/carboplatin + gemcitabine (for squamous only) carboplatin + paclitaxel

Assegnazione: Non-Randomized

Modello di intervento: Parallel Assignment

Scopo principale: Treatment

Mascheramento: None (Open Label)