A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combinatio… (NCT04623775) | Clinical Trial Compass
CompletedPhase 2
A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)
United States, Argentina, Australia468 participantsStarted 2021-02-17
Plain-language summary
The purpose of this study is to assess the safety profile of relatlimab plus nivolumab in combination with platinum doublet chemotherapy (PDCT) and to determine if nivolumab plus relatlimab in combination with PDCT improves overall response rate (ORR) when compared to nivolumab plus PDCT in participants with previously untreated Stage IV or recurrent non-small cell lung cancer (NSCLC).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Histologically confirmed metastatic non-small cell lung cancer (NSCLC) of squamous (SQ) or non-squamous (NSQ) histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of less than or equal to 1 at screening and confirmed prior to randomization.
* Measurable disease by computed tomography (CT) or magnetic resonance resources (MRI) per response evaluation criteria in solid tumor version 1.1 (RECIST 1.1) criteria.
* No prior systemic anti-cancer treatment (including epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors) given as primary therapy for advanced or metastatic disease.
Exclusion Criteria
* Participants with EGFR, ALK, ROS-1, or known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF V600E) mutations that are sensitive to available targeted therapy.
* Untreated CNS metastases.
* Leptomeningeal metastases (carcinomatous meningitis).
* Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to randomization (ie, participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization and the participant has no evidence of disease).
* Prior treatment with an anti-programmed cell death protein 1 (PD-1), …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is already completed — does that mean results are available, and if so, what did they find about how well relatlimab plus nivolumab with chemotherapy worked compared to nivolumab with chemotherapy alone for stage IV or recurrent NSCLC?
2Since this was a Phase 2 trial, what does that mean for how confident we can be about the safety and effectiveness of adding relatlimab to the standard nivolumab-plus-chemotherapy regimen — and is a larger Phase 3 trial happening next?
3One of the main things this trial measured was treatment-related side effects serious enough to cause people to stop treatment within the first 12 weeks — based on what's known from this study, how common was that, and what kinds of side effects should I watch out for with this combination?
4Given that this trial tested a first-line treatment for stage IV or recurrent NSCLC, how does adding relatlimab to nivolumab and chemotherapy compare to the standard options already available to me, and would you recommend I consider one of those standard approaches first?
5Is the combination of relatlimab, nivolumab, and chemotherapy being offered anywhere now as a result of this trial's findings, or is it still experimental — and what does that mean for my treatment options today?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
TRAEs Leading to Discontinuation Within 12 Weeks of First Dose in Part 1
Timeframe: from first dose to 12 weeks after first dose