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

A Phase II, Open-Label, Multicenter 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

Sponsor

Lead Sponsor: Hoffmann-La Roche

Fonte Hoffmann-La Roche
Breve riassunto

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.

Stato generale Recruiting
Data d'inizio 2021-04-09
Data di completamento 2027-02-28
Data di completamento principale 2027-02-28
Fase Phase 2
Tipo di studio Interventional
Il risultato principale
Misurare Lasso di tempo
Number of Participants With Surgical Delays Up to approximately 6 years
Number of Participants With Operative and Post-operative Complications Up to approximately 6 years
Number of Participants With Surgical Cancellations Related to Study Treatment Up to approximately 6 years
Percentage of Participants With Adverse Events Up to approximately 6 years
Percentage of Participants Who Achieve Major Pathological Response (MPR) At the time of surgery (approximately Weeks 17-20)
Esito secondario
Misurare Lasso di tempo
Percentage of Participants With Pathological Complete Response (pCR) At the time of surgery (approximately Weeks 17-20)
Event Free Survival (EFS) From baseline to disease progression that precludes surgical resection, or local or distant disease recurrence after surgery, or death from any cause (up to approximately 6 years)
Serum Concentrations of Atezolizumab Day 1 of Cycle 1 (cycle=21 days): pre-dose and 30 minutes (min) post-dose; Day 1 of Cycles 2, 3, 4, 5, 8, 12, 16: pre-dose; at treatment discontinuation (TD) visit (up to approximately 9 months)
Serum Concentrations of Tiragolumab Day 1 of Cycle 1 (cycle=21 days): pre-dose and 30 min post-dose; Day 1 of Cycles 2, 3, 4, 5, 8, 12, 16: pre-dose; at TD visit (up to approximately 9 months)
Percentage of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab Prior to the first infusion on Day 1 of Cycles 1, 2, 3, 4, 5, 8, 12 and 16 (cycle=21 days) and at TD visit (up to approximately 9 months)
Percentage of Participants With ADAs to Tiragolumab Prior to the first infusion on Day 1 of Cycles 1, 2, 3, 4, 5, 8, 12 and 16 (cycle=21 days) and at TD visit (up to approximately 9 months)
Iscrizione 82
Condizione
Intervento

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.

Eleggibilità

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

Ufficiale generale
Cognome Ruolo Affiliazione
Clinical Trials Study Director Hoffmann-La Roche
Contatto generale

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]

Posizione
Servizio, struttura: Stato:
City of Hope Cancer Center; Division of Medical Oncology & Experimental Therapeutics | Duarte, California, 91010, United States Recruiting
University of Southern California | Los Angeles, California, 90033, United States Not yet recruiting
Cedars Sinai Medical Center | Los Angeles, California, 90048, United States Not yet recruiting
Georgetown U; Lombardi Comp Can | Washington, District of Columbia, 20016-1468, United States Not yet recruiting
Washington University School of Medicine; Medical Oncology | Saint Louis, Missouri, 63110, United States Not yet recruiting
NYU Cancer Center | New York, New York, 10016, United States Not yet recruiting
Columbia University | New York, New York, 10032-3725, United States Not yet recruiting
Hospital Univ Vall d'Hebron; Servicio de Oncologia | Barcelona, 08035, Spain Not yet recruiting
Universitaetsspital Basel; Onkologie | Basel, 4031, Switzerland Not yet recruiting
Kantonsspital St. Gallen; Onkologie/Hämatologie | St. Gallen, 9007, Switzerland Recruiting
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie | Zürich, 8091, Switzerland Not yet recruiting
Paesi di posizione

Spain

Switzerland

United States

Data di verifica

2021-04-01

Parte responsabile

Genere: Sponsor

Ha accesso esteso No
Condizione Sfoglia
Numero di armi 2
Braccio di gruppo

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

Dati del paziente Yes
Informazioni sul design dello studio

Assegnazione: Non-Randomized

Modello di intervento: Parallel Assignment

Scopo principale: Treatment

Mascheramento: None (Open Label)

Fonte: ClinicalTrials.gov

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