Immunotherapy and Chemotherapy for Advanced Non-Small Cell Lung Cancer
This study is for people with newly diagnosed, advanced non-small cell lung cancer (NSCLC) that has spread (Stage IV). It aims to understand if a blood test called circulating tumor DNA (ctDNA) can help doctors decide whether you need only immunotherapy (Nivolumab and Ipilimumab) or if you also need chemotherapy (Carboplatin, Paclitaxel, or Pemetrexed). You must have a certain level of PD-L1 (a protein on cancer cells) and be willing to have regular ctDNA blood tests. The main goal is to see how long people live without their cancer getting worse (Progression Free Survival) for up to 36 months.
- Study design
- This study will enroll 108 participants and involves a 2:1 randomization, meaning more participants will be in one treatment group. Participants will start with immunotherapy, and then some will have their treatment adjusted based on ctDNA test results.
- What's involved
- You will receive intravenous (IV) treatments of Nivolumab and Ipilimumab, and potentially chemotherapy. You will also have regular ctDNA blood tests and CT scans every 12 weeks to check your cancer.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your Progression Free Survival will be measured for up to 36 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy
At a glance
Conditions
Where it's being run
3 sites across 2 statesStudy leadership
- Martin Gutierrez, MD · PRINCIPAL_INVESTIGATOR · Hackensack Meridian Health
Who to contact
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What this trial measures
- Progression Free Survival (PFS)Time from randomization to objective disease progression, or death from any cause, whichever first, up to 36 months
To compare progression free survival in patients with on-treatment-ctDNA guided therapy continuation or escalation by addition of platinum-doublet chemotherapy to therapy continuation with Nivolumab-Ipilimumab regardless of on-treatment-ctDNA results.