ALK, but without EGFR, HER-2 or MET exon14 skipping mutations, regardless of PD-L1 status, RET or NTRK rearrangements., ROS1, Stage III NSCLC patients with loco-regional relapse > 12 months from the end of CRT +/- < 3 metastatic lesions after PACIFIC regimen or PACIFIC-like regimens (concurrent or sequential chemo-radiotherapy followed by maintenance durvalumab)
Conditions
Brief summary
To assess the safety and tolerability, in terms of number of grade 3 or higher adverse events judged as at least possibly related to study treatment regimen (radiotherapy followed by systemic therapy with ceralasertib and durvalumab) within 6 months from the start of study treatment., To assess the efficacy in terms of PFS, defined as the time from the date of enrolment until the date of first disease progression or death to any cause, whichever comes first
Detailed description
To assess the activity in terms of objective response rate (ORR)., To assess the efficacy in terms of PFS rate at 6 and 12 months, OS, OS rate at 6 and 12 months. OS is defined as the time from enrolment until the date of death from any cause., To assess the safety and tolerability of the treatment.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability, in terms of number of grade 3 or higher adverse events judged as at least possibly related to study treatment regimen (radiotherapy followed by systemic therapy with ceralasertib and durvalumab) within 6 months from the start of study treatment., To assess the efficacy in terms of PFS, defined as the time from the date of enrolment until the date of first disease progression or death to any cause, whichever comes first | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the activity in terms of objective response rate (ORR)., To assess the efficacy in terms of PFS rate at 6 and 12 months, OS, OS rate at 6 and 12 months. OS is defined as the time from enrolment until the date of death from any cause., To assess the safety and tolerability of the treatment. | — |
Countries
Italy