RADICAL-IO: thRee cycles of immunotherApy without raDical therapy In mediCALly InOperable stage I non-small cell lung cancer

Conditions

Stage I non-small cell lung cancer

Brief summary

Time from first cemiplimab administration to disease recurrence/progression as per RECIST 1.1, fatal TRAEs or NSCLC-related death

Detailed description

Time from first cemiplimab administration to disease recurrence/progression as per RECIST 1.1 or death of any cause, 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, Objective response rate as per RECIST 1.1, Best objective response as per RECIST 1.1, Time between objective response to disease recurrence as per RECIST 1.1, Time from first cemiplimab administration to local, regional and distant disease recurrence/progression, Overall survival: Time from first cemiplimab administration to death of any cause, Disease-specific survival: Time from first cemiplimab administration to NSCLC-related death

Related papers

No related papers found yet.

Interventions

DRUGLIBTAYO 350 mg concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time from first cemiplimab administration to disease recurrence/progression as per RECIST 1.1, fatal TRAEs or NSCLC-related death	—

Secondary

Measure	Time frame
Time from first cemiplimab administration to disease recurrence/progression as per RECIST 1.1 or death of any cause, 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, Objective response rate as per RECIST 1.1, Best objective response as per RECIST 1.1, Time between objective response to disease recurrence as per RECIST 1.1, Time from first cemiplimab administration to local, regional and distant disease recurrence/progression, Overall survival: Time from first cemiplimab administration to death of any cause, Disease-specific survival: Time from first cemiplimab administration to NSCLC-related death	—

Measure

Time frame

Time from first cemiplimab administration to disease recurrence/progression as per RECIST 1.1 or death of any cause, 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, Objective response rate as per RECIST 1.1, Best objective response as per RECIST 1.1, Time between objective response to disease recurrence as per RECIST 1.1, Time from first cemiplimab administration to local, regional and distant disease recurrence/progression, Overall survival: Time from first cemiplimab administration to death of any cause, Disease-specific survival: Time from first cemiplimab administration to NSCLC-related death

—

Outcome results

None listed