Brief description of trial (Data source: BASEC)
Das primäre Ziel der Studie ist es die Effizienz von Nivolumab + CCRT gefolgt von Nivolumab + Ipilimumab (Arm A) vs CCRT gefolg von Druvalumab (Arm C) in Patienten mit unbehandeltem, lokal fortgeschrittenem Nicht-Kleinzelligem Lungenkarzinom zu vergleichen
Health conditions investigated(Data source: BASEC)
Nicht-Kleinzelliges Lungenkarzinom (NSCLC)
Health conditions
(Data source: WHO)
Non-Small Cell Lung Cancer (NSCLC)
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
- Nivolumab, Arzneimittel, Arm A+B, bestimmte Dosis an bestimmten Tagen
- Ipilimumabh, Arzneimittel, Arm A, Q6W in der Erhaltungsphase in Arm A
- Durvalumab, Arzneimittel, Arm C, Q2W in der Erhaltungsphase in Arm C
Interventions
(Data source: WHO)
Biological: nivolumab;Biological: ipilimumab;Biological: durvalumab
Criteria for participation in trial
(Data source: BASEC)
- Eastern Cooperative Oncology (ECOG) Performance Status ≤ 1
- Lokal fortgeschrittener NSCLC im Stadium IIIA, IIIB, IIIC (T1-2 N2-3 Mo, T3 N1-3 M0, or T4 N0-3 M0), der histologisch nach TNM-Klassifikation (8. Edition) bestätigt wurde
- Neu diagnostiziert und chemo-naiv, mit keiner lokalen oder systemischen vorherigen Anti-Krebstherapie, die als primäre Therapie für die lokal-fortgeschrittene Krankheit gegeben wurde
Exclusion criteria
(Data source: BASEC)
- Jeder Zustand, einschließlich medizinischer, emotionaler, psychiatrischer oder logistischer Natur, der nach Ansicht des Prüfers den Patienten von der Einhaltung des Protokolls ausschließen oder das mit der Teilnahme an der Studie verbundene Risiko erhöhen würde.
- Vorbehandlung mit einem anti-PD-1-, anti-PD-L1-, anti-PD-L2- oder anti-CTLA-4-Antikörper oder einem anderen Antikörper oder Medikament, das speziell auf die T-Zell-Costimulation oder die Kontrollpunkte ausgerichtet ist.
- Aktive Infektion, die eine systemische Therapie innerhalb von 14 Tagen vor der Randomisierung erfordert.
- Vorherige aktive Malignität innerhalb der letzten drei Jahre, mit Ausnahme von lokal heilbaren Krebsarten, die offensichtlich geheilt wurden
- Teilnehmer mit einer aktiven, bekannten oder vermuteten Autoimmunerkrankung oder einer Erkrankung, die eine systemische Behandlung mit Kortikosteroiden (> 10 mg Prednisonäquivalent täglich) oder anderen immunsuppressiven Medikamenten innerhalb von 14 Tagen nach Beginn der Randomisierung erfordert
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 =1
- Locally advanced stage IIIA, IIIB, or IIIC (T1-2 N2-3 M0, T3 N1-3 M0, or T4 N0-3 M0)
pathologically-confirmed NSCLC, according to 8th TNM classification. Participants who
are not planned for potential curative surgical resection are eligible.
- Newly diagnosed and treatment-na?ve, with no prior local or systemic anticancer
therapy given as primary therapy for locally advanced disease
Exclusion Criteria:
- Any condition including medical, emotional, psychiatric, or logistical that, in the
opinion of the Investigator would preclude the participant from adhering to the
protocol or would increase the risk associated with study participation
- Active infection requiring systemic therapy within 14 days prior to randomization
- History of organ or tissue transplant that requires systemic use of immune suppressive
agents
- Prior thoracic radiotherapy
Other protocol-defined inclusion/exclusion criteria apply
-
Further information on trial
Recruitment status
Active, not recruiting
Academic title
(Data source: WHO)
A Phase 3, Randomized, Open Label Study to Compare Nivolumab Plus Concurrent Chemoradiotherapy (CCRT) Followed by Nivolumab Plus Ipilimumab or Nivolumab Plus CCRT Followed by Nivolumab vs CCRT Followed by Durvalumab in Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Data source: WHO)
Phase 3
Primary end point
(Data source: WHO)
Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm A vs Arm C
Secundary end point
(Data source: WHO)
Overall Survival (OS) for Arm A vs Arm C;PFS by RECIST 1.1 per BICR for Arm B vs Arm C;OS for Arm B vs Arm C;PFS by RECIST 1.1 per BICR for Arm A vs Arm B;OS for Arm A vs Arm B;Objective Response Rate (ORR) by RECIST 1.1 per BICR;Duration of Response (DoR) by RECIST 1.1 per BICR;Time to Response (TTR) by RECIST 1.1 per BICR;PFS by RECIST 1.1 per Investigator assessment;ORR by RECIST 1.1 per Investigator assessment;DoR by RECIST 1.1 per Investigator assessment;TTR by RECIST 1.1 per Investigator assessment;Time to Death or Distant Metastases (TTDM) by RECIST 1.1 per Investigator assessment;Incidence of Adverse Events (AEs);Incidence of Serious Adverse Events (SAEs);Incidence of select AEs;Proportion of participants without symptom deterioration based on NSCLC-SAQ
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, Lausanne, St. Gallen
Countries
(Data source: WHO)
Argentina, Australia, Belgium, Brazil, Canada, Chile, China, France, Germany, Greece, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Poland, Puerto Rico, Republic of, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Prof. Dr. Martin Früh
+41 71 494 10 68
martin.Frueh@kssg.ch
Contact for general information
(Data source: WHO)
Bristol-Myers Squibb
Bristol-Myers Squibb
Contact for scientific information
(Data source: WHO)
Bristol-Myers Squibb
Bristol-Myers Squibb
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Ethikkommission Ostschweiz (EKOS)
Date of authorisation by the ethics committee
16.01.2020
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2019-01523
Secondary ID (Data source: WHO)
2019-001222-98
CA209-73L
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