Clinical trial · Observational
A Study to Assess Safety of Nivolumab in Routine Oncology Practice in China
The Observational Safety Study for Nivolumab in China Routine Oncology Practice
- 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 this study is to assess the safety of nivolumab in routine cancer practice in China. Part one of the study will investigate nivolumab for non-small cell lung cancer previously treated with platinum-based chemotherapy that has locally advanced or has spread. Part two will investigate nivolumab for post-platinum squamous cell carcinoma of head and neck that is recurrent or has spread. Part three will investigate nivolumab for locally advanced or metastatic non-small cell lung cancer. Part four will investigate nivolumab for recurrent or metastatic squamous cell carcinoma of head and neck.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma of Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (4)
- label
- Cohort 1
- description
- Prospective observation of participants with non-small cell lung cancer (NSCLC)
- label
- Cohort 2
- description
- Prospective observation of participants with squamous cell carcinoma of head and neck (SCCHN)
- label
- Cohort 3
- description
- Retrospective observation of participants with NSCLC
- label
- Cohort 4
- description
- Retrospective observation of participants with SCCHN
Primary outcomes (10)
- measure
- Incidence rate of nivolumab-related immune-related adverse events (irAEs)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Part 1 * Histologically or cytologically confirmed diagnosis of locally advanced/metastatic non-small cell lung cancer (NSCLC) participants * Treatment with nivolumab per physician's prescription Part 2 * Histologically or cytologically confirmed diagnosis of recurrent/metastatic squamous cell carcinoma of head and neck (SCCHN) * Treatment with nivolumab for recurrent or metastatic SCCHN Part 3 * Histologically or cytologically confirmed diagnosis of locally advanced/metastatic NSCLC * Participants with at least one dose of nivolumab administered since June 2018 Part 4 * Histologically or cytologically confirmed diagnosis of recurrent/metastatic SCCHN * Participants with at least one dose of nivolumab administered since September 2019 Exclusion Criteria: * Prior participation in a clinical trial within the past 4 weeks * Current or pending participation in a clinical trial * Current or pending systemic treatment for cancer other than NSCLC for part 1 and SCCHN for part 2 * Previously treated with immune checkpoint inhibitors for part 3 and part 4 * Participants must not have any other concurrent primary tumor(s) for part 3 and part 4 Other protocol-defined inclusion/exclusion criteria apply
References
Publications (0)
Data not yet available