The primary objective of this study is to determine the feasibility of four weeks of preoperative immunotherapy with Nivolumab, and Nivolumab plus Relatlimab in patients with early stage or locally advanced non-small cell lung cancer eligible for curative resection.
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:
* Patients with histologically confirmed non-small cell lung cancer (NSCLC) eligible for anatomic resection (Clinical stages I B, II and selected stage III A)
* Eastern Cooperative Oncology Group (ECOG) ≤ 1
* Sufficient pulmonary function to undergo curative lung cancer surgery
* Adequate hematological, hepatic and renal function parameters:
* Sufficient cardiac left ventricular defined as left ventricular ejection fraction (LVEF) ≥ 50% documented either by echocardiography or multigated acquisition scan (MUGA)
* Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures
Exclusion Criteria:
* Active or history of autoimmune disease or immune deficiency
* Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration
* Subjects who have undergone organ transplant or allogeneic stem cell transplantation
* Uncontrolled or significant cardiovascular disease
* Patients with active neurological disease
* Active malignancy or a prior malignancy within the past 3 years
* Receipt of live attenuated vaccine within 30 days prior to the first dose of study medication
* Peripheral polyneuropathy NCI CTCAE Grade ≥ 2
* History of gastric perforation or fistulae in past 6 months
* Serious or non-healing wound, ulcer, or bone fracture within 28 days …
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 tested nivolumab alone or combined with different doses of relatlimab before surgery in Stage I, II, or IIIA non-small cell lung cancer — based on what the results showed, does this kind of pre-surgery immunotherapy approach look promising enough for someone in my stage to consider?
2Since this was a Phase 2 trial focused on whether the four-week pre-surgery treatment was even feasible to complete, what do we know so far about safety — were there immune-related side effects that could delay or complicate surgery?
3The trial is now completed — have any results been published yet, and if so, what did they find about how the tumor responded to nivolumab with or without relatlimab before surgery?
4Relatlimab was tested at two different doses in this trial — does the dose used affect what risks I'd need to think about, and does my doctor know which dose showed a better profile?
5Given that this trial has finished enrolling, are there similar or follow-up trials now open that build on what this study found, or would standard treatment before surgery be a more established option for me to consider first?
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
Feasibility of four weeks of preoperative immunotherapy with Nivolumab, Nivolumab plus Relatlimab (80 mg), and Nivolumab plus Relatlimab (240 mg)
Timeframe: Within 43 days after first study medication