New study examines Real-World side effects of lung cancer therapies
NCT ID NCT07215962
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tracks 300 patients with advanced non-small cell lung cancer whose tumors have low PD-L1 levels (below 1%). Researchers will look at side effects and healthcare use for different first-line treatments, including combinations of immunotherapy drugs like nivolumab and ipilimumab with or without chemotherapy. The goal is to understand how these treatments work in everyday practice, outside of controlled clinical trials.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Nivolumab, ipilimumab, and other immunotherapy drugs combined with chemotherapy
- What this could lead to
- If successful, this could help doctors choose safer and more effective first-line treatments for advanced lung cancer patients with low PD-L1 levels.
- What could go wrong
- This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may not apply to all patients or settings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Nov 2024
- Expected to finish
-
Mar 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population will comprise of programmed death ligand 1 (PD-L1) negative individuals diagnosed with advanced/metastatic non-small cell lung cancer (NSCLC) who received first-line therapy in routine clinical practice at the Florida Cancer Specialists and Research Institute
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Non-small cell lung cancer (NSCLC) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Florida Cancer Specialists & Research Institute
Fleming Island, Florida, 32003, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Wearables guide home prehab for older lung cancer patients
- Can immunotherapy outperform chemotherapy for lung cancer?
- Can a cocktail of immune boosters shrink Hard-to-Treat tumors?
- Wearable tech and digital rehab may shorten recovery between lung cancer surgeries
- Can a targeted pill boost lung cancer treatment?
- A new strategy to tame lung cancer Drug's nerve pain?