Clinical trial · Observational
A Study in Participants With First-Line Nivolumab Plus Ipilimumb Therapy Combined With Two Cycles of Chemotherapy for Metastatic Non-Small Cell Lung Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Cohort 1
- description
- Participants with Metastatic Non-Small Cell Lung Cancer
Primary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
- Up to 5 years
Secondary outcomes (14)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available