Traditionally, chemotherapy and/or immunotherapy are combined with surgery or radiotherapy to cure patients with lung cancer. However, some patients treated with immunotherapy appear to be cured before surgery or radiotherapy. In this study, patients with a high chance to respond to immunotherapy will be selected. These patients will be treated with immunotherapy alone, thereby evaluating whether these patients can be cured without surgery or radiotherapy.
Have pathologically proven newly diagnosed, treatment-naive stage IA (i.e. tumor diameter ≤ 3 cm) NSCLC according to the 9th AJCC/UICC staging classification (30).
Be willing and able to provide written informed consent/assent for the trial.
Be 18 years of age on day of signing informed consent.
Should have measurable disease according to RECIST 1.1.
Has a known driver mutation associated with lack of cemiplimab efficacy (e.g. EGFR, ALK, HER2, RET or ROS1). Patients with smoking-related targetable driver mutation (e.g. KRAS or BRAF non-V600E) are eligible for this study. If this is unavailable, a patient should have smoked ≥10 packyears to be eligible.
Has a known mutation in STK11 and/or KEAP1 predictive of poor response to PD-(L)1 inhibitors.
Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the 1st dose of treatment.
Has received prior therapy with any antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways other than PD-(L)1 blockade, e.g. anti-CD137 or a CTLA-4 antibody.
Single group
Cemiplimab 350 mg IV
Drugthree cycles of 350 milligrams of cemiplimab intravenously every three weeks
Recurrence free survival (RFS) as per RECIST 1.1
Time from first cemiplimab administration to disease recurrence/progression as per RECIST 1.1, fatal TRAEs or NSCLC-related death.
Estimate event free survival
Time from first cemiplimab administration to disease recurrence/progression as per RECIST 1.1 or death of any cause
Evaluate safety
Grade \>3 TRAEs classified by NCI-CTCAE v5 up until 90 days after the last cemiplimab cycle, in particular pneumonitis. Rate of local radical therapy after disease recurrence.
Estimate survival
Overall survival (time from first cemiplimab administration to death of any cause) and disease specific survival (time from first cemiplimab administration to NSCLC related death)
Estimate location of disease recurrence
Time from first cemiplimab administration to local, regional and distant disease recurrence/progression
Click on the lead sponsor to view all of their trials.
The Netherlands Cancer Institute
Lead sponsor
Leiden University Medical Center
Collaborator
Regeneron Pharmaceuticals
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
