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AUSTRAL trial: An open-label, multicenter, phase II study of radiotherapy followed by durvalumab (MEDI4736) and ceralasertib (AZD6738) in stage III NSCLC patients with thoracic relapses +/- oligometastases after PACIFIC regimen

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515942-18-01
Enrollment
17
Registered
2025-07-03
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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)

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

DRUGDURVALUMAB
DRUGCeralasertib

Sponsors

Istituto Di Ricerche Farmacologiche Mario Negri
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026