NCT07215962Completed
Long-Term Safety Outcomes and First-Line Treatment Patterns in Patients With Non-Small Cell Lung Cancer and Programmed Death-1 (Pd-L1) <1%
Real-World Long-Term Safety Outcomes and First-Line Treatment Patterns in Patients With Non-Small Cell Lung Cancer and Pd-L1 <1% in the Florida Cancer Specialists & Research Institute Database
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 300 (actual)
- First submitted
- 9 Oct 2025
- Start date
- 22 Nov 2024
- Primary completion date
- 1 Jul 2025
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Lung cancer
- NCT number
- NCT07215962
What you commit to
- Study type: Observational
- Participants enrolled: 300
- From 22 Nov 2024 to the primary completion date, 1 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Were included in a clinical trial for 1L therapy
- Have other concurrent primary cancer diagnoses
Lab values
- Have positive or unknown EGFR or ALK mutation before the index date
Other
- Have a gap of \> 120 days between metastatic NSCLC diagnosis and index date
- Enter a hospice within 6 months of the follow-up will be excluded
Who the study is looking for
- Are ≥ 18 years of age at the index date
- Have a confirmed diagnosis of advanced/metastatic non-small cell lung cancer (NSCLC) (stage IIIB-IV) (squamous and non-squamous)
- Have PD-L1\< 1% level as reported
- Received one of the following 1L treatments:
- Cohort 1: nivolumab + ipilimumab
- Cohort 2: nivolumab + ipilimumab + platinum-based chemotherapy
- Cohort 3: Immuno-oncology (IO)-based therapy (excluding nivolumab-based regimens) with chemotherapy
- Cohort 4: Dual-IO with chemotherapy (eg. tremelimumab-actl + durvalumab + carboplatin + albumin-bound paclitaxel, tremelimumab-actl + durvalumab + \[carboplatin or cisplatin\] + gemcitabine, tremelimumab-actl + durvalumab + carboplatin + albumin-bound paclitaxel, tremelimumab-actl + durvalumab + \[carboplatin or cisplatin\] + pemetrexed)
- Have ≥ 6 months of documented post-index (follow-up) period after the index date - Participants who die within 6 months of follow-up will be included
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Florida Cancer Specialists & Research Institute Coordinator of this site? Confirm its status | Fleming Island | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.