Clinical trial NCT04794010: A Study in Participants With First-Line Nivolumab Plus Ipilimumb Therapy Combined With Two Cycles of Chemotherapy for Metastatic Non-Small Cell Lung Cancer
Official title: A German, Nationwide, Prospective, Observational, Multicenter Study in Patients With First-line Nivolumab Plus Ipilimumab Therapy Combined With Two Cycles of Chemotherapy for Metastatic Non-Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Non-Small Cell Lung Cancer
NSCLC
Nivolumab
Ipilimumab
Chemotherapy
Metastatic
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-03-11
Enrollment: 825
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: It is planned to include 825 patients at 100 sites in Germany in this observational study from marketing authorization by the European Medicines Agency (EMA) onwards.

The planned recruitment phase is approximately 24 months, the planned follow-up phase 60 months from the day of nivolumab plus ipilimumab plus two cycles of chemotherapy initiation (D0).

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).


Eligibility criteria: 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

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Overall Survival (OS) according to subgroups of interest
timeFrame: Up to 5 years
measure: Progression-free survival (PFS)
timeFrame: Up to 5 years
measure: Duration of treatment
timeFrame: Up to 5 years
measure: Distribution of socio-demographic characteristics of participants
timeFrame: At Baseline
measure: Distribution of clinical characteristics of participants
timeFrame: At Baseline
measure: Description of participant-reported outcomes (PROs) of participants using European Quality of Life-5 Dimensions (EQ-5D) questionnaires
timeFrame: Up to 5 years
measure: Description of participant-reported outcomes (PROs) of participants using Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)
timeFrame: Up to 5 years
measure: Management of AEs: Treatment of AEs
timeFrame: Up to 5 years
measure: Management of AEs: Date of occurrence of AE
timeFrame: Up to 5 years
measure: Management of AEs: Start of treatment
timeFrame: Up to 5 years
measure: Treatment Patterns: Previous therapies
timeFrame: Up to 5 years
measure: Treatment Patterns: Subsequent therapies
timeFrame: Up to 5 years
measure: Treatment patterns: Concomitant medication
timeFrame: Up to 5 years
measure: Treatment patterns : Management of treatment-related adverse events [AEs], previous and subsequent therapies
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Local Institution - 0001
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: