At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓ECOG Performance Status 0-2
- ✓Life expectancy ≥6 months at start of treatment
- ✓Body weight >30kg
- ✕Discontinued durvalumab due to local or systemic progression <12 months after CRT
- ✕Grade ≥3 immune-related toxicity (except fully recovered endocrine toxicities) or grade ≥3 radiation-induced pneumonitis during durvalumab maintenance
- ✕Unresolved toxicity from prior anticancer therapy except alopecia, vitiligo, and specified lab values
- ✕Toxicity that led to permanent discontinuation of prior immunotherapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Durvalumab (MEDI4736), Ceralasertib, and 1 other intervention for Non Small Cell Lung Cancer NSCLC. Currently recruiting, targeting 21 participants across 9 sites in 2 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Durvalumab will be administered via IV infusion at a dose of 1500 mg on day 8 Q4W until confirmed disease progression unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.
Ceralasertib dose will be administered orally, 240mg BID, approximately 12 ± 2 hours apart, days 1 to 7 q28 (Q4W), up to progression or unacceptable toxicity.
Loco-regional recurrences of the primary tumor and regional lymph node metastases will be treated with a total dose of 36 to 50 Gy in daily fractions with a dose of 2 to 3 Gy per fraction. Two weeks from the last dose of radiotherapy, a systemic treatment with durvalumab and ceralasertib will be started.