Inserire di nuova l’introduzione
NCT04026412 | SNCTP000003679

Eine Studie mit Nivolumab und Ipilimumab bei zuvor unbehandelten Patienten mit NSCLC im Stadium 3, das entweder inoperabel ist oder bei dem keine chirurgische Entfernung des Tumors geplant ist

Base di dati: BASEC (Importata da 24.05.2020), WHO (Importata da 22.03.2020)
Cambiato: 14.05.2020
Categoria di malattie: Lungenkrebs

Descrizione riassuntiva della sperimentazione (Fonte di dati: 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

Malattie studiate (Fonte di dati: BASEC)

Nicht-Kleinzelliges Lungenkarzinom (NSCLC)

Health conditions (Fonte di dati: WHO)

Non-Small Cell Lung Cancer (NSCLC)

Malattia rara (Fonte di dati: BASEC)

No

Interventi esaminati (p. es. medicamento, terapia, campagna) (Fonte di dati: 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 (Fonte di dati: WHO)

Drug: Nivolumab;Drug: Ipilimumab;Drug: Durvalumab

Criteri per la partecipazione alla sperimentazione (Fonte di dati: 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

Criteri di esclusione (Fonte di dati: 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 (Fonte di dati: WHO)


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)
histologically-confirmed NSCLC, according to 8th TNM classification.

- Newly diagnosed and treatment-naïve, 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 patient from adhering to the protocol
or would increase the risk associated with study participation.

- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or
any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint
pathways.

- Active infection requiring systemic therapy within 14 days prior to randomization.

- Prior malignancy active within the previous 3 years except for locally curable cancers
that have been apparently cured,

- Participants with an active, known or suspected autoimmune disease or a condition
requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone
equivalent) or other immunosuppressive medications within 14 days of start of
randomization.

- History of organ or tissue transplant that requires systemic use of immune suppressive
agents.

- Clinical evidence of hearing loss and prior thoracic radiotherapy.

Other protocol defined inclusion/exclusion criteria could apply

Altri dati sulla sperimentazione nel registro primario dell’OMS

https://clinicaltrials.gov/show/NCT04026412

Altri dati sulla sperimentazione dalla banca dati dell’OMS (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT04026412

Altre informazioni sulla sperimentazione

Data di registrazione della sperimentazione

18.07.2019

Inserimento del primo partecipante

20.08.2019

Stato di reclutamento

Recruiting

Titolo scientifico (Fonte di dati: 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)

Tipo di sperimentazione (Fonte di dati: WHO)

Interventional

Disegno della sperimentazione (Fonte di dati: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Fase (Fonte di dati: WHO)

Phase 3

Punti finali primari (Fonte di dati: WHO)

Progression Free Survival (PFS) Assessed by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm A and Arm C;Overall Survival (OS) for Arm A and Arm C

Punti finali secondari (Fonte di dati: WHO)

Overall Survival (OS) for Arm B and Arm C;Progression Free Survival (PFS) Assessed as per BICR for Arm B and Arm C;Objective Response Rate (ORR) and Complete Response Rate Assessed as per BICR;Duration of Response (DOR) Assessed as per BICR;Time to Response (TTR) Assessed as per BICR;Time to Death or Distant Metastases (TTDM) Assessed as per BICR;Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and select AEs;Percentage of Participants Without Meaningful Symptom Deterioration Following 48 Weeks of Maintenance Therapy Based on Lung Cancer Subscale (LCS) of FACT-L and NSCLC-SAQ

Contatto per informazioni (Fonte di dati: WHO)

Please refer to primary and secondary sponsors

Siti di esecuzione della sperimentazione

Siti di esecuzione in Svizzera (Fonte di dati: BASEC)

Basel, Lausanne, St Gallen

Paesi di esecuzione (Fonte di dati: WHO)

Argentina, Australia, Belgium, Brazil, Canada, Chile, France, Germany, Greece, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Poland, Puerto Rico, Republic of, Romania, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States

Contatto per maggiori informazioni sulla sperimentazione

Dati della persona di contatto in Svizzera (Fonte di dati: BASEC)

Dr. Martin Früh
+41 71 494 10 68
Martin.Früh@kssg.ch

Contatto per informazioni generali (Fonte di dati: WHO)

Bristol-Myers Squibb;Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Bristol-Myers Squibb
please email:
Clinical.Trials@bms.com

Contatto per informazioni scientifiche (Fonte di dati: WHO)

Bristol-Myers Squibb;Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Bristol-Myers Squibb
please email:
Clinical.Trials@bms.com

Responsabile della sperimentazione

Sponsor principale (Fonte di dati: WHO)

Bristol-Myers Squibb

Altri numeri di identificazione delle sperimentazioni

BASEC ID (Fonte di dati: BASEC)

2019-01523

Secondary ID (Fonte di dati: WHO)

2019-001222-98;CA209-73L