Brief description of trial (Data source: BASEC)
Die klinische Studie dient zur Beurteilung der Sicherheit und Wirksamkeit von Tiragolumab plus Tecentriq® im Vergleich zu einer Behandlung mit Placebo plus Tecentriq® bei Patienten mit unbehandeltem fortgeschrittenem nicht-kleinzelligem Lungenkrebs (NSCLC). Die Gruppe, der die Patienten zugeordnet werden, wird nach dem Zufallsprinzip bestimmt (wie bei dem Werfen einer Münze). Die Wahrscheinlichkeit, einer der beiden Gruppen zugeordnet zu werden, ist gleich hoch. Weder die Patienten noch Ihr Prüfarzt können die Gruppe, der sie zugeordnet werden, auswählen oder kennen.
Health conditions investigated(Data source: BASEC)
Nicht-kleinzelliger Lungenkrebs
Health conditions
(Data source: WHO)
Non-Small Cell Lung Cancer
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Experimenteller Arm A:
Atezolizumab 1200mg + Tiragolumab 600mg über die Vene
Kontrollarm B:
Atezolizumab 1200mg + Placebo über die Vene
Die Gaben erfolgen alle 3 Wochen
Interventions
(Data source: WHO)
Drug: Atezolizumab;Drug: Tiragolumab;Drug: Matching Placebo
Criteria for participation in trial
(Data source: BASEC)
- Histologisch oder zytologisch bestätigter, lokal fortgeschrittener oder wiederkehrender nicht-kleinzelliger Lungekrebs, der nicht für eine operative Entfernung und/oder eine definitive Chemoradiotherapie in Frage kommt oder metastasierter Stufe IV nicht-kleinzelliger Lungenkrebs (Pathologie: Plattenepithel oder nicht-Plattenepithel)
- Keine vorherige systemische Therapie gegen metastasiertes NSCLC
- Tumor positiv für Biomarker PD-L1 getestet (Tumor-Proportionswert über 50%)
Exclusion criteria
(Data source: BASEC)
- Nicht-kleinzelliger Lungenkrebs mit bekannter Mutation im EGFR Gen oder ALK Fusion Onkogen
- Lymphoepitheliom-ähnlicher Karzinomsubtyp des nicht-kleinzelligen Lungentumors in der Lunge
-Symptomatische, unbehandelte oder aktiv wachsende Metastasen im Zentralnervensystem
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Histologically or cytologically documented locally advanced or recurrent NSCLC not
eligible for curative surgery and/or definitive radiotherapy with or without
chemoradiotherapy, or metastatic Stage IV non-squamous or squamous NSCLC
- No prior systemic treatment for metastatic NSCLC
- High tumor tissue PD-L1 expression
- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1
(RECIST v1.1)
- Adequate hematologic and end-organ function
- For participants enrolled in the extended China enrollment phase: current resident of
mainland China or Taiwan and of Chinese ancestry.
Exclusion Criteria:
- Known mutation in the EGFR gene or an ALK fusion oncogene
- Symptomatic, untreated, or actively progressing central nervous system metastases
- 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
- Malignancies other than NSCLC within 5 years, with the exception of those with a
negligible risk of metastasis or death treated with expected curative outcome
- Severe infection within 4 weeks prior to initiation of study treatment
- Positive test result for human immunodeficiency virus (HIV)
- Active hepatitis B or hepatitis C
- Treatment with investigational therapy within 28 days prior to initiation of study
treatment
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies,
anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug elimination
half-lives prior to initiation of study treatment.
-
Further information on trial
Recruitment status
Active, not recruiting
Academic title
(Data source: WHO)
A Phase III, Randomized, Double-Blinded, Placebo-Controlled Study of Tiragolumab, an Anti-Tigit Antibody, in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
Phase
(Data source: WHO)
Phase 3
Primary end point
(Data source: WHO)
Investigator-Assessed Progression-Free Survival (PFS) in the Primary Analysis Set;Overall Survival (OS) in the Primary Analysis Set;Percentage of Participants With Adverse Events (AEs);Percentage of Participants With Cytokine-Release Syndrome (CRS)
Secundary end point
(Data source: WHO)
Investigator-Assessed PFS in the Secondary Analysis Set;OS in the Secondary Analysis Set;Investigator-Assessed Confirmed Objective Response Rate (ORR);Investigator-Assessed Duration of Response (DOR);Investigator-Assessed PFS Rates at 6 Months and 12 Months;OS Rates at 12 Months and 24 Months;Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Score
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Basel, Bern, Lausanne, St. Gallen
Countries
(Data source: WHO)
Argentina, Australia, Austria, Brazil, China, Denmark, France, Germany, Greece, Hungary, Italy, Japan, Korea, Mexico, Netherlands, Peru, Poland, Republic of, Russian Federation, Serbia, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Alexandra Kreutz
+41 61 715 44 93
switzerland.clinical-research@roche.com
Contact for general information
(Data source: WHO)
Clinical Trial
Hoffmann-La Roche
Contact for scientific information
(Data source: WHO)
Clinical Trial
Hoffmann-La Roche
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
Date of authorisation by the ethics committee
23.04.2020
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2020-00166
Secondary ID (Data source: WHO)
2019-002925-31
2022-502482-17-00
GO41717
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