Clinical trial · Observational
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
NCT07215962CI-TRIAL-00096525active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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 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
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 |
|---|---|---|---|
| Non-small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immuno-oncology-based therapy (excluding nivolumab-based regimens) with chemotherapy | Biological | — | UNRESOLVED |
| Nivolumab + ipilimumab | Biological | Ipilimumab/Nivolumab Regimen | ALIAS |
| Nivolumab + ipilimumab + platinum-based chemotherapy | Biological | — | UNRESOLVED |
| Other dual-immuno-oncology therapy with chemotherapy | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Cohort 1
- description
- Participants receiving nivolumab + ipilimumab treatment
- interventionNames
- Biological: Nivolumab + ipilimumab
- label
- Cohort 2
- description
- Participants receiving nivolumab + ipilimumab + platinum-based chemotherapy
- interventionNames
- Biological: Nivolumab + ipilimumab + platinum-based chemotherapy
- label
- Cohort 3
- description
- Participants receiving immuno-oncology therapy (excl nivolumab) with chemotherapy treatment
- interventionNames
- Biological: Immuno-oncology-based therapy (excluding nivolumab-based regimens) with chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.