Status:
ACTIVE_NOT_RECRUITING
Long-Term Safety Outcomes and First-Line Treatment Patterns in Patients With Non-Small Cell Lung Cancer and Programmed Death-1 (Pd-L1) <1%
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Non-small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Brief Summary
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/met...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Have positive or unknown EGFR or ALK mutation before the index date
- Have a gap of \> 120 days between metastatic NSCLC diagnosis and index date
- Were included in a clinical trial for 1L therapy
- Enter a hospice within 6 months of the follow-up will be excluded
- Have other concurrent primary cancer diagnoses
Key Trial Info
Start Date :
November 22 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07215962
Start Date
November 22 2024
End Date
March 1 2026
Last Update
October 14 2025
Active Locations (1)
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1
Florida Cancer Specialists & Research Institute
Fleming Island, Florida, United States, 32003