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Active, Not Recruiting

NCT Number: 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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0001

Leipzig, 04277, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall survival (OS)

    Time frame: Up to 5 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Acronym: FINN

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Mar 11, 2021
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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