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SNCTP000004453 | NCT04294810 | BASEC2020-00166

Eine Studie zur Untersuchung von Sicherheit und Wirksamkeit von Tecentriq® und Tiragolumab im Vergleich zu Tecentriq® allein bei Patienten mit nicht vorbehandeltem lokal fortgeschrittenem, inoperablem oder metastasiertem nicht-kleinzelligem Lungenkrebs

Data source: BASEC (Imported from 29.11.2021), WHO (Imported from 18.04.2021)
Changed: 14.10.2021
Disease category: Lung Cancer

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)


Inclusion Criteria:

- 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

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- 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

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 the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT04294810

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04294810

Further information on trial

Date trial registered

02.03.2020

Incorporation of the first participant

04.03.2020

Recruitment status

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 Population;Overall Survival (OS) in the Primary Population

Secundary end point (Data source: WHO)

Investigator-Assessed PFS in the Secondary Population;OS in the Secondary Population;Investigator-Assessed PFS in Participants With High Tumor Programmed Death-Ligand 1 (PD-L1) Expression;OS in Participants With High Tumor PD-L1 Expression;Investigator-Assessed Confirmed Objective Response Rate (ORR);Investigator-Assessed Duration of Response (DOR);Percentage of Participants With ADAs to Atezolizumab;Percentage of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab;Cmax of Atezolizumab;Cmin of Atezolizumab;Maximum Serum Concentration (Cmax) of Tiragolumab;Minimum Serum Concentration (Cmin) of Tiragolumab;Percentage of Participants With Adverse Events (AEs);Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Score;OS Rates at 12 Months and 24 Months;Investigator-Assessed PFS Rates at 6 Months and 12 Months

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;Reference Study ID Number: GO41717 www.roche.com/about_roche/roche_worldwide.htm
Hoffmann-La Roche
888-662-6728 (U.S. Only)
global-roche-genentech-trials@gene.com

Contact for scientific information (Data source: WHO)

Clinical Trial;Reference Study ID Number: GO41717 www.roche.com/about_roche/roche_worldwide.htm
Hoffmann-La Roche
888-662-6728 (U.S. Only)
global-roche-genentech-trials@gene.com

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

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
GO41717