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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
Aim of this phase 2 study is to explore the safety and efficacy of thoracic re-irradiation +/- SBRT to oligometastases (\<3) followed after an interval of 2 weeks by durvalumab and ceralasertib for patients with thoracic relapses +/- oligometastases after PACIFIC or PACIFIC-like (concurrent or sequential chemo-radiotherapy followed by maintenance durvalumab) regimens.
Details
| Lead sponsor | Mario Negri Institute for Pharmacological Research |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 21 |
| Start date | 2025-08-07 |
| Completion | 2029-01 |
Conditions
- Non Small Cell Lung Cancer NSCLC
Interventions
- Durvalumab (MEDI4736)
- Ceralasertib
- radiotherapy
Primary outcomes
- Safety and tolerability, in terms of number of grade 3 or higher adverse events judged as at least possibly related to study treatment regimen — within 6 months from the start of study treatment
- PFS — 12 months
PFS is defined as the time from the date of enrolment until the date of first disease progression or death to any cause, whichever comes first.
Countries
Italy, Switzerland