Long-Term Safety Outcomes and First-Line Treatment Patterns in Patients With Non-Small Cell Lung Cancer and Programmed Death-1 (Pd-L1) <1%

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-22

Study Completion Date

2026-03-01

Brief Summary

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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

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Detailed Description

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Conditions

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Non-small Cell Lung Cancer (NSCLC)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

According to the product label

Intervention Type BIOLOGICAL

Nivolumab + ipilimumab + platinum-based chemotherapy

According to the product label

Intervention Type BIOLOGICAL

Immuno-oncology-based therapy (excluding nivolumab-based regimens) with chemotherapy

According to the product label

Intervention Type BIOLOGICAL

Other dual-immuno-oncology therapy with chemotherapy

According to the product label

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No