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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

Data source: BASEC (Imported from 07.04.2020), WHO (Imported from 22.03.2020)
Changed: 26.03.2020
Disease category: Lungenkrebs

Brief description of trial (Source of data: 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 (Source of data: BASEC)

Nicht-Kleinzelliges Lungenkarzinom (NSCLC)

Health conditions (Source of data: WHO)

Non-Small Cell Lung Cancer (NSCLC)

Rare disease (Source of data: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Source of data: 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 (Source of data: WHO)

Drug: Nivolumab;Drug: Ipilimumab;Drug: Durvalumab

Criteria for participation in trial (Source of data: 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 (Source of data: 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 (Source of data: 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

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT04026412

Further information on the trial from WHO database (ICTRP)

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

Further information on trial

Date trial registered

18.07.2019

Incorporation of the first participant

20.08.2019

Recruitment status

Recruiting

Academic title (Source of data: 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 (Source of data: WHO)

Interventional

Design of the trial (Source of data: WHO)

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

Phase (Source of data: WHO)

Phase 3

Primary end point (Source of data: 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

Secundary end point (Source of data: 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

Contact information (Source of data: WHO)

Please refer to primary and secondary sponsors

Trial sites

Trial sites in Switzerland (Source of data: BASEC)

Basel, Lausanne, St Gallen

Countries (Source of data: 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

Contact for further information on the trial

Details of contact in Switzerland (Source of data: BASEC)

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

Contact for general information (Source of data: 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

Contact for scientific information (Source of data: 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

Principal Sponsor/Investigator

Principal sponsor (Source of data: WHO)

Bristol-Myers Squibb

Further trial identification numbers

BASEC ID (Source of data: BASEC)

2019-01523

Secondary ID (Source of data: WHO)

2019-001222-98;CA209-73L