A Study in Participants With First-Line Nivolumab Plus Ipilimumb Therapy Combined With Two Cycles of Chemotherapy for Metastatic Non-Small Cell Lung Cancer

Studien-Informationen Einschlusskriterien Studien-Rationale

Rekrutierend

NCT-Nummer:
NCT04794010

Studienbeginn:
Dezember 2020

Letztes Update:
15.09.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Bristol-Myers Squibb

Collaborator:
-

Studienleiter

Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb

Kontakt

BMS Study Connect Contact Center http://www.bmsstudyconnect.com
Kontakt:
Phone: 855-907-3286
E-Mail: Clinical.Trials@bms.com» Kontaktdaten anzeigen

First line of the email MUST contain NCT # and Site #.

Studienlocations
(1 von 1)

Local Institution - 0001
04277 Leipzig
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Site 0001» Ansprechpartner anzeigen

Studien-Informationen

Brief Summary:

The purpose of the study is to collect real-life data during the early post-market

authorization approval period in Germany.

The study aims at describing the outcomes, patient characteristics, safety profile, treatment

patterns and patient-reported Quality of Life of first-line treatment with nivolumab plus

ipilimumab in combination with two cycles of chemo therapy in participants with confirmed

stage IV Non-Small Cell Lung Cancer (NSCLC).

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Diagnosis of stage IV Non-Small Cell Lung Cancer (NSCLC) (histologically or

cytologically confirmed stage), without known Epidermal Growth Factor Receptor (EGFR)-

or Anaplastic Lymphoma Kinase (ALK)-alterations (according to label approved by EU)

- Decision to initiate a first-line treatment with nivolumab plus ipilimumab combined

with two cycles of chemotherapy for the treatment of NSCLC according to the German

label has been made independently of the study

Exclusion Criteria:

- Current primary diagnosis of a cancer other than NSCLC that requires systemic or other

treatment

- Participants with known EGFR- or ALK-alterations

Other protocol-defined inclusion/exclusion criteria apply

Studien-Rationale

Primary outcome:

1. Overall survival (OS) (Time Frame - Up to 5 years)

Secondary outcome:

1. Overall Survival (OS) according to subgroups of interest (Time Frame - Up to 5 years)

2. Progression-free survival (PFS) (Time Frame - Up to 5 years)

3. Duration of treatment (Time Frame - Up to 5 years)

4. Distribution of socio-demographic characteristics of participants (Time Frame - At Baseline):
Age, Sex, Ethnicity, Height, Weight and BMI

5. Distribution of clinical characteristics of participants (Time Frame - At Baseline):
Histology subtype, Tumor stage, Location or primary tumor and Location of metastases

6. Description of participant-reported outcomes (PROs) of participants using European Quality of Life-5 Dimensions (EQ-5D) questionnaires (Time Frame - Up to 5 years)

7. Description of participant-reported outcomes (PROs) of participants using Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) (Time Frame - Up to 5 years)

8. Management of AEs: Treatment of AEs (Time Frame - Up to 5 years)

9. Management of AEs: Date of occurrence of AE (Time Frame - Up to 5 years)

10. Management of AEs: Start of treatment (Time Frame - Up to 5 years)

11. Treatment Patterns: Previous therapies (Time Frame - Up to 5 years)

12. Treatment Patterns: Subsequent therapies (Time Frame - Up to 5 years)

13. Treatment patterns: Concomitant medication (Time Frame - Up to 5 years)

14. Treatment patterns : Management of treatment-related adverse events [AEs], previous and subsequent therapies (Time Frame - Up to 5 years)

Quelle: ClinicalTrials.gov

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