Long-Term Safety Outcomes and First-Line Treatment Patterns in Patients With Non-Small Cell Lung Cancer and Programmed Death-1 (Pd-L1) <1%
Part of paid clinical trials in Fleming Island, Florida.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT07215962
- Status
- Active Not Recruiting
Conditions
- Non-small Cell Lung Cancer (NSCLC)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nivolumab + ipilimumab — BIOLOGICALAccording to the product label
- Nivolumab + ipilimumab + platinum-based chemotherapy — BIOLOGICALAccording to the product label
- Immuno-oncology-based therapy (excluding nivolumab-based regimens) with chemotherapy — BIOLOGICALAccording to the product label
- Other dual-immuno-oncology therapy with chemotherapy — BIOLOGICALAccording to the product label
Study Details
The purpose of this study is to assess the treatment-related adverse events and associated healthcare resource use in programmed death ligand 1 (PD-L1) negative individuals diagnosed with advanced/metastatic non-small cell lung cancer (NSCLC) who received first-line therapy
Key Dates
- Start date
- Nov 22, 2024
- Status verified
- Oct 2025
- Primary completion
- Jul 1, 2025
- Completion
- Mar 1, 2026
Study Design
- Enrollment
- 300 participants (estimated)
Arms
- Arm: Cohort 1Participants receiving nivolumab + ipilimumab treatment
- Arm: Cohort 2Participants receiving nivolumab + ipilimumab + platinum-based chemotherapy
- Arm: Cohort 3Participants receiving immuno-oncology therapy (excl nivolumab) with chemotherapy treatment
- Arm: Cohort 4Participants receiving other dual-IO with chemotherapy
Primary Outcome Measure
Incidence of treatment-related adverse events [ Time Frame: Baseline ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Florida Cancer Specialists & Research Institute | Fleming Island | Florida | 32003 | - |
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