Trials / Recruiting
RecruitingNCT06680050
Phase II Study of Radiotherapy Followed by Durvalumab and Ceralasertib in Stage III NSCLC Patients With Thoracic Relapses +/- Oligometastases After PACIFIC Regimen
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
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- Sponsor
- Mario Negri Institute for Pharmacological Research · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Durvalumab (MEDI4736) | 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. |
| DRUG | Ceralasertib | 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. |
| RADIATION | radiotherapy | 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. |
Timeline
- Start date
- 2025-08-07
- Primary completion
- 2028-06-01
- Completion
- 2029-01-01
- First posted
- 2024-11-08
- Last updated
- 2025-12-18
Locations
9 sites across 2 countries: Italy, Switzerland
Source: ClinicalTrials.gov record NCT06680050. Inclusion in this directory is not an endorsement.