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, we will select patients with a high chance to respond to immunotherapy. These patients will be treated with immunotherapy alone, thereby evaluating whether these patients can be cured without surgery or radiotherapy.
Early-stage non-small cell lung cancer (NSCLC) patients with a pathological complete response (pCR) to neoadjuvant chemoimmunotherapy are potentially already cured before the local radical treatment is administered. However, treatment de-escalation in these patients is unfeasible since pCR detection before local radical treatment is unreliable. We propose to evaluate whether we can safely omit local radical therapy after immunotherapy in selected patients with stage Ia NSCLC with high probability of immunotherapy benefit. Participants receive three cycles of 350 milligrams of cemiplimab intravenously every three weeks followed by a radiological and metabolic response evaluation with respectively CT and \[18F\]FDG-PET. Thereafter patients will enter the follow-up phase where response will be closely monitored with CT scans 3-monthly. Additionally, blood will be collected for ctDNA analysis at baseline, during treatment with cemiplimab and follow-up will be collected. According to standard of care, patients will undergo a \[18F\]FDG-PET scan if progressive disease is suspected. Participants with disease recurrence will be treated off-study at the discretion of the treating physician.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
three cycles of 350 milligrams of cemiplimab intravenously every three weeks
Netherlands Cancer Institute - Antoni van Leeuwenhoek
Amsterdam, Netherlands
Leids Universitair Medisch Centrum (LUMC)
Leiden, Netherlands
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.
Time frame: 24 months
Estimate event free survival
Time from first cemiplimab administration to disease recurrence/progression as per RECIST 1.1 or death of any cause
Time frame: 24 months
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.
Time frame: 24 months
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)
Time frame: 24 months
Estimate location of disease recurrence
Time from first cemiplimab administration to local, regional and distant disease recurrence/progression
Time frame: 24 months
Objective reponse rate (ORR)
Objective response rate as per RECIST 1.1
Time frame: 24 months
BoR
Best objective response rate as per RECIST 1.1
Time frame: 24 months
DoR
Time between objective response to disease recurrence as per RECIST 1.1
Time frame: 24 months
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